Category: Device Advisories

FDA Advisory No. 2020-1233 || Public Health Warning Against the Purchase and Use of the Medical Device Product “Infusion Set with needle in foreign text”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “Infusion Set with needle in foreign text”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the Food and Drug Administration Act of 2009”, the manufacture, promotion, advertising and or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 857-1900 loc. 8301.          

To report any sale or distribution of unregistered medical device, email us at ereport[email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1233

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1233 || Public Health Warning Against the Purchase and Use of the Medical Device Product “Infusion Set with needle in foreign text”

FDA Advisory No. 2020-1232 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Doctor’s Choice® Pregnancy Test”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “Doctor’s Choice® Pregnancy Test”

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Certificate of Product Registration (CPR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1232

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1232 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Doctor’s Choice® Pregnancy Test”

FDA Advisory No. 2020-1231 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Pregnancy Test Kit in Foreign Markings”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “Pregnancy Test Kit in Foreign Markings”

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Certificate of Product Registration (CPR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1231

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1231 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Pregnancy Test Kit in Foreign Markings”

FDA Advisory No. 2020-1230 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

  1. Yuwell Clinical Digital Thermometer (YT308)
  2. Yuwell Clinical Thermometer”

The FDA verified through post-marketing surveillance that the abovementioned medical device products are not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through the evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDRs are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1230

FDA Advisory No. 2020-1229 || Public Health Warning Against the Purchase and Use of the Medical Device Product “HCG Test Paper in Foreign Character”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “HCG Test Paper in Foreign Character”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the Food and Drug Administration Act of 2009”, the manufacture, promotion, advertising and or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1229

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1229 || Public Health Warning Against the Purchase and Use of the Medical Device Product “HCG Test Paper in Foreign Character”

FDA Advisory No. 2020-1228 || Public Health Warning Against the Purchase and Use of the Unnotified/Unregistered Medical Device Product “DR. GU SINGLE-USE MEDICAL RUBBER EXAMINATION GLOVES”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified/unregistered medical device product:

  1. “DR. GU SINGLE-USE MEDICAL RUBBER EXAMINATION GLOVES”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified/registered and no corresponding Certificate of Medical Device Notification (CMDN) / Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified/unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDN/CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified/unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1228

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1228 || Public Health Warning Against the Purchase and Use of the Unnotified/Unregistered Medical Device Product “DR. GU SINGLE-USE MEDICAL RUBBER EXAMINATION GLOVES”

FDA Advisory No. 2020-1227 || Public Health Warning Against the Purchase and Use of the Following Unnotified Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

  1. Nuo Kang Adhesive Bandages
  2. Band-Aid Brand Adhesive Bandages Benzalkonium Chloride Patches

The FDA verified through post-marketing surveillance that the abovementioned medical device products are unnotified and no corresponding product notification certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unnotified medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the product notification certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number in the form of either DVR-xxxx, MDR-xxxx, or IVDR-xxxx on the product label.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unnotified products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1227

FDA Advisory No. 2020-1226 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “KUNGFU® CONDOMS IN FOREIGN CHARACTERS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “KUNGFU® CONDOMS IN FOREIGN CHARACTERS”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1226

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1226 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “KUNGFU® CONDOMS IN FOREIGN CHARACTERS”

FDA Advisory No. 2020-1225 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

  1. LONGTHIN JOYFUL PLAYER 003
  2. THIN (CONDOMS) IN FOREIGN CHARACTERS

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1225

FDA Advisory No. 2020-1224 || Public Health Warning Against the Purchase and Use of the Unnotified/Unregistered Medical Device Product “YUNNAN BAIYAO PLASTER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified/unregistered medical device product:

  1. “YUNNAN BAIYAO PLASTER”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified/registered and no corresponding Certificate of Medical Device Notification (CMDN) / Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified/unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDN/CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified/unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1224

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1224 || Public Health Warning Against the Purchase and Use of the Unnotified/Unregistered Medical Device Product “YUNNAN BAIYAO PLASTER”

FDA Advisory No. 2020-1223 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “NATURAL LATEX RUBBER CONDOM in Foreign Characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “NATURAL LATEX RUBBER CONDOM in Foreign Characters”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.     

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1223

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1223 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “NATURAL LATEX RUBBER CONDOM in Foreign Characters”

FDA Advisory No. 2020-1222 || Public Health Warning Against the Purchase and Use of the following Unnotified/Unregistered Medical Device Products In Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified/unregistered medical device products:

  1. Nuo Kang Adhesive TAPE
  2. Peng Cheng Gauze Bandage (4.8 cm x 6 m)

The FDA verified through post-marketing surveillance that the abovementioned medical device products are not notified/registered and no corresponding Certificate of Medical Device Notification(CMDN)/Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unnotified/unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDN/CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unnotified/unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.    

To report any sale or distribution of unnotified/unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1222

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1222 || Public Health Warning Against the Purchase and Use of the following Unnotified/Unregistered Medical Device Products In Foreign Characters:

FDA Advisory No. 2020-1221 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Device Products in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

  1. SYRINGE NEEDLE
  2. ZYMM SYRINGE WITH NEEDLE (1mL and 2 mL)

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                             

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1221

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1221 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Device Products in Foreign Characters:

FDA Advisory No. 2020-1205 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “THERMOMETER in Foreign Characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “THERMOMETER in Foreign Characters”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

 Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1205

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1205 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “THERMOMETER in Foreign Characters”

FDA Advisory No. 2020-1204 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “STER/LANCE – SOFT LANCETS 26G”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “STER/LANCE – SOFT LANCETS 26G”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.       

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1204

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1204 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “STER/LANCE – SOFT LANCETS 26G”

FDA Advisory No. 2020-1203 || Public Health Warning Against the Purchase and Use of the Unnotified/Unregistered Medical Device Product “GAUZE BANDAGE 8cm x 6m”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified/unregistered medical device product:

  1. GAUZE BANDAGE 8cm x 6m

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified/registered and no corresponding Certificate of Medical Device Notification (CMDN) / Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified/unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CMDN/CMDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified/unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1203

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1203 || Public Health Warning Against the Purchase and Use of the Unnotified/Unregistered Medical Device Product “GAUZE BANDAGE 8cm x 6m”

FDA Advisory No. 2020-1202 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Device Products in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

  1. TRUEMAN CONDOM
  2. SV-V CONDOMS – SMOOTH & THIN FRAGRANCE
  3. DUREX CONDOM – LOVE SEX

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Certificate of Medical Device Registration (CMDR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1202

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1202 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Device Products in Foreign Characters:

FDA Advisory No. 2020-1181 || List of FDA Notified Medical Face Masks

In the interest of protecting public health and safety, the Food and Drug Administration (FDA) hereby provides the list of registered face masks for medical use as of 16 June 2020:

  PRODUCT NAME COMPANY NAME
1 Blue Cross Disposable Surgical Mask Pharmatechnica Laboratory Inc.
2 Disposable Face Mask Hexagon Medical Supplies
3 Face Mask PM2.5 Disposable Mask Funtastic International, Inc.
4 Indoplas Face Masks Indoplas Philippines, Inc.
5 Indoplas KN95 Face Mask Indoplas Philippines Inc.
6 Indoplas Face Mask Indoplas Philippines Inc.
7 KN95 Disposable Face Mask Funtastic International, Inc.
8 McBride Device Name: KN95 Protective Mask AMB HK Enterprises Inc.
9 McBride Face Mask AMB HK Enterprises Inc.
10 Mediclean Device Name: Face Mask AMB HK Enterprises Inc.
11 Resprotec Disposable Surgical Mask Pharmatechnica Laboratory, Inc.
12 Safeplus Face Mask AMB HK Enterprises Inc.
13 Safeplus Face Mask For Kids AMB HK Enterprises Inc.
14 Safeplus KN95 Protective Mask AMB HK Enterprises Inc.
15 Sure-Guard Carbon Face Mask AMB HK Enterprises Inc.
16 Sure-Guard Face Mask AMB HK Enterprises Inc.
17 Sure-Guard® Device Name: KN95 Protective Mask AMB HK Enterprises Inc.

The above list shall be regularly updated. For reference, please click the link: https://docs.google.com/spreadsheets/d/1OAE1MAByyve9wcqKiwlVifGtMUCoaHe7ntgSwV9JMvw/edit#gid=0

Retailers, hospitals and other healthcare facilities are hereby advised to procure only FDA notified medical face masks from FDA licensed manufacturers and distributors.

The public is enjoined to be vigilant in the purchase and use of face masks in light of the proliferation of these products in the market to curb the spread of COVID-19. The public is likewise advised to purchase health products only from legitimate and reputable retailers or establishments.

In addition, the FDA informs all concerned of the list of respirators (N95, KN95 or similar face masks) that failed the performance requirement of greater than or equal to 95 percent (%) filtration efficiency assessed by the United States (US) Centers for Disease Control and Prevention (CDC) – The National Institute for Occupational Safety and Health (NIOSH). These products were recalled and are currently not authorized by the US-FDA. The public is advised not to use these respirators especially healthcare workers who provide care to COVID-19 patients in settings and areas where aerosol generating procedures are undertaken. The list can be accessed at https://www.fda.gov/media/137928/download.

For more information and inquiries, kindly contact the FDA – Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1181

FDA Advisory No. 2020-1081 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical devices:

  1. Neuramis® Lidocaine 1×1 mL/2x(30G 1/2″)
  2. Neuramis® Deep Lidocaine 1×1 mL/2x(27G 1/2″)

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificates of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR is issued, otherwise, regulatory actions and sanctions shall he strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1081

FDA Advisory No. 2020-1079 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device “XUELIAN SURGICAL TAPE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unnotified medical device:

  1. “XUELIAN SURGICAL TAPE”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not notified and no Certificate of Medical Device Notification (CMDN) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CMDN is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857­1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1079

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1079 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device “XUELIAN SURGICAL TAPE”

FDA Advisory No. 2020-1078 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Non-Contact IR Thermometer”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. “Non-Contact IR Thermometer”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1078

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1078 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Non-Contact IR Thermometer”

FDA Advisory No. 2020-1077 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

  1. BELLAST ULTRA PLUS CROSS-LINKED HYALURONIC ACID 24MG WITH LIDOCAINE
  2. STYLAGE IPN — LIKE TECHNOLOGY XXL LIDOCAINE BI-SOFT INJECTION TECHNOLOGY
  3. STYLAGE IPN — LIKE TECHNOLOGY M LIDOCAINE

The FDA verified through post-marketing surveillance that the abovementioned medical device products are not registered and no corresponding Certificate of Product Registration has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CPRs are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at cdr[email protected]or call (02) 8857­1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1077

FDA Advisory No. 2020-1064 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device “Nuo Adhesive Bandage (In Foreign Characters)” 

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unnotified medical device:

  1. “Nuo Adhesive Bandage (In Foreign Characters)”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not notified and the Certificate of Medical Device Notification (CMDN) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CMDN is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1064

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1064 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device “Nuo Adhesive Bandage (In Foreign Characters)” 

FDA Advisory No. 2020-1051 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices in Foreign Characters:

The Food and Drug Administration (FDA) warns the general public and all healthcare professionals against the purchase and use of the unregistered medical devices:

  1. Medical Infusion Paste
  2. Donless Natural Rubber Latex Male Condom
  3. Disposable Vaginal Speculum
  4. Infusion Set for Single Use with Needle

The FDA verified through post-marketing surveillance conducted on 26 May 2020 that the above mentioned medical device is not registered and no Certificate of Product Registration (CPR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at ww2.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected]or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1051

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1051 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices in Foreign Characters:

FDA Advisory No. 2020-1080 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “WIZ BIOTECH Diagnostic Kit (Colloidal Gold) for IgG/ImM Antibody to SARS-CoV-2”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the sale and purchase of the uncertified Covid-19 test kit:

  1. “WIZ BIOTECH Diagnostic Kit (Colloidal Gold) for IgG/ImM Antibody to SARS-CoV-2”

The FDA verified through post-marketing surveillance conducted on 05 June 2020 that the abovementioned medical device is not certified and/or no Special Certification has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

Furthermore, FDA Circular 2020-016 entitled “Prohibition of Online Selling of FDA Certified Covid-19 Antibody Test Kits” prohibits online selling and commercial use of such products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected].

To report any sale or distribution of unregistered/uncertified medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1080

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1080 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “WIZ BIOTECH Diagnostic Kit (Colloidal Gold) for IgG/ImM Antibody to SARS-CoV-2”

FDA Advisory No. 2020-1055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFRARED THERMOMETER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medica device:

  1. “INFRARED THERMOMETER”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of-health products without the proper authorization is prohibited.

Since these unregistered medical devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1055

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFRARED THERMOMETER”

FDA Advisory No. 2020-1054 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the uncertified Covid-19 test kit:

  1. “Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette”

The FDA verified through post-marketing surveillance that the above mentioned medical device is not certified and/or no Special Certification has been issued as of 27 May 2020. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this uncertified medical device has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

Furthermore, FDA Circular No. 2020-016 entitled “Prohibition of Online Selling of FDA Certified Covid-19 Antibody Test Kits” prohibits online selling and commercial use of such products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected].

To report any sale or distribution of unregistered/uncertified medical devices, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested

Attachment:-> FDA Advisory No.2020-1054

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1054 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Testsealabs One Step Rapid Test- SARS-cov-2 IgG/IgM Test Cassette”

FDA Advisory No. 2020-1053 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical devices:

  1. KX white box (Type C, Infusion Sticker)
  2. 10ml Syringe

The FDA verified through post-marketing surveillance conducted on 28 May 2020 that the abovementioned medical device is not registered and no Certificate of Product Registration (CPR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1053

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1053 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices in Foreign Characters:

FDA Advisory No. 2020-1052 || Public Health Warning Against the Purchase and Use of the Following Unnotified BioSwiss Medical Devices

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unnotified medical devices:

  1. Taco Bandage
  2. Pineapple Bandage
  3. Bandage

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not notified and the Certificates of Medical Device Notification (CMDN) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CMDNs are issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected] , or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1052

FDA Advisory No. 2020-1057 || ON THE USE OF RADIATION DEVICES IN THE DIAGNOSIS OF COVID-19 INFECTIONS

Due to the COVID-19 pandemic, techniques in the diagnosis of persons with probable or suspected cases has been rapidly evolving. A review of statements and guidelines issued by international and local expert societies points to an increase in the use of radiation devices to augment such efforts. The American College of Radiology (ACR) issued recommendations last March 11, 2020 which pointed out that radiation devices should be used with caution and for justified clinical indications only. This has been reiterated by the Philippine College of Radiology (PCR) and its associate societies, the CT-MRI Society of the Philippines (CMSP) and the Ultrasound Society of the Philippines (LISP), through the issuance of separate guidelines and recommendations.

In view thereof, the FDA advises all medical radiation facilities to abide by the interim guidelines and protocols set by the Department of Health (DOH) in the diagnosis of COVID­19 infections. Department Memorandum (DM) No. 2020-0138 or the “Adoption of PSMID Clinical Practice Guidelines on COVID-19″ states that real time polymerase chain reaction assay (RT-PCR assay) is the recommended test to confirm COVID-19 infection and chest imaging/radiological procedures are part of patient assessment, monitoring, and guidance to clinical treatment depending on epidemiological risk factors.

As such, diagnostic radiation devices (e.g. x-ray machines, CT Scans, MRIs, point-of­care ultrasound machine, etc.) should not be used as firstline diagnostic tool for COVID­19. No practice involving exposure to harmful radiation should be adopted without proper justification. These devices can instead be utilized to supplement the management of confirmed cases with infection control protocols set-up following the recommendations of the DOH.’

For more information and inquiries, you may contact the Center for Device Regulation, Radiation Health, and Research (CDRRHR) at (02) 8815-9600 or email us [email protected]  or [email protected].

Attachment:-> FDA Advisory No.2020-1057

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