Category: Device Advisories

FDA Advisory No. 2020-547 || Updated Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs Release

Due to the rapid spread of COVID-19, the following updated measures are adopted for the expedient release of certain protective equipment (PPE) withn the jurisdiction of the Bureau of Customs.  The PPE include:

  1. Face masks including N95 masks
  2. Shoe Covers
  3. Gloves
  4. Head Covers, and
  5. Gowns

For the abovementioned PPE intended for entry to the local market for commercial use, the presentation of the copy of the importer’s License to Operate (LTO) should be sufficient compliance for customs release.

For foreign donation of the same PPE, clearance from FDA shall not be needed.  These include companies, other than medical device establishments, with employees who use face masks in the performance of their jobs and are strictly for company use.

Strict postmarket surveillance will be implemented to all these PPEs.  All companies who have imported PPEs under this Advisory and will continue to distribute PPEs for commercial purposes shall apply for Certificate of Medical Device Notification (CMDN) within three (3) months after the lifting of Proclamation No. 922 s. 2020 declaring a State of Public Health Emergency throughout the Philippines.  Necesssary regulatory measures will be implemented to those companies who will not comply with this requirement.

Said procedure for clearance of PPE prior to customs release shall be in effect otherwise lifted.

This advisory supersedes FDA Advisory No. 2020-420 issued on 20 March 2020.

For your guidance.

Attachment:->FDA Advisory No.2020-547

FDA Advisory No. 2020-513 || FDA Approves the First Locally Manufactured Test Kit for COVID-19 for Commercial Use

The Food and Drug Administration (FDA) has now approved the Real-Time PCR for the detection of COVID-19 manufactured by the Manila HealthTek, Inc. for commercial use.

The test kit was previously approved by the FDA for field trial. with gene sequencing on 10 March 2020.  Upon the company’s submission of necessary requirements today, the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use.

This is the first locally made PCR based COVID-19 test kit approved by the FDA which was developed in collaboration with the University of the Philippines-National Institute of Health (UP-NIH), funded by the Department of Science and Technology (DOST).

Aside from this PCR based test kit, the FDA has approved one additional rapid test kit today, which brings the total number of COVID-19 approved test kits to 30. The FDA will continue to update the public on COVID-19 testing kits approval.

Attachment:->FDA Advisory No.2020-513

FDA Advisory No. 2020-497 || DISTRIBUTION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS

The Food and Drug Administration (FDA) reiterates to all licensed importer/distributor that COVID-19 test kits is strictly for use of medical professional use and not intended for personal use.

The product should be strictly distributed to appropriate establishments or institutions. Subsequently, this should be acquired by the general public through a prescription from a licensed physician. The administration of the test must be performed by a doctor or a trained health professional. Furthermore, the interpretation of results must be done by a doctor.

Attachment:-> FDA Advisory No.2020-497

FDA Advisory No. 2018-309-A || Lifting the Advisory of the Registered Medical Device Product “Air Life Gauze Bandage 4” x 10 yds, 40’s/40’s 19 x 10 mesh under FDA Advisory No. 2018-309 “Public Health Warning Against the Purchase and Use of Medical Device with Expired Certificate of Product Registration (CPR) “

The Food and Drug Administration (FDA) informs the public that the medical device product Air Life Gauze Bandage 4″ x 10 yds, 40’s/40’s 19 x 10 mesh with CPR No. MDR-08861, has been registered by the Market Authorization Holder (MAH), Airlife International Trading Corporation, in accordance to existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2018-309 is hereby lifted.

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 products, email us at [email protected].

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2018-309-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-309-A || Lifting the Advisory of the Registered Medical Device Product “Air Life Gauze Bandage 4” x 10 yds, 40’s/40’s 19 x 10 mesh under FDA Advisory No. 2018-309 “Public Health Warning Against the Purchase and Use of Medical Device with Expired Certificate of Product Registration (CPR) “

FDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19

In line with the ongoing response to the increasing number of COVID-19 cases in the Philippines, the Food and Drug Administration (FDA)- Philippines hereby provides an initial list of approved Rapid Antibody Test Kits.

PRODUCT NAME MANUFACTURER
1. NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT Biolidics Limited. – 37 Jalan Pemimpin, #02-07, Mapex, Singapore
2. NOVEL CORONAVIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD) Nanjing Vazyme Medical Technology Co., Ltd – Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China
3. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) Zhuhai Livzon Diagnostic Inc. – 1st Building, No. 266, Tongchang Road, Xiangzhou District, Zhuhai, Guangdong Province, People’s Republic of China
4. 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) Innovita (Tangshan) Biological Technology Co., Ltd. – No. 699 Juxin Street, High-Tech Industrial Development Zone, Qian’an 064400, Hebei, China
5. SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD) Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, People’s Republic of China

This list shall be regularly updated. For reference please click the link.

https://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez

To report any sale or distribution of COVID-19 rapid test kits not included in the list, you may email us at [email protected].

Attachment:->FDA Advisory No.2020-483

FDA Advisory No. 2020-178-A || Lifting the Advisory of the Registered Medical Device under FDA Advisory No. 2020-178. Subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Alaris® Secondary Syringe Adapter”

The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device product “Alaris® Secondary Syringe Adapter” has been registered by the Market Authorization Holder (MAH), KSM Healthcare Inc., with FDA registration number MDR-04674 in accordance to existing FDA rules and regulations

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-178 is hereby lifted.

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 products, email us at [email protected]

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2020-178-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-178-A || Lifting the Advisory of the Registered Medical Device under FDA Advisory No. 2020-178. Subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Alaris® Secondary Syringe Adapter”

FDA Advisory No. 2020-447 || WALA PANG APRUBADONG POINT-OF-CARE O INSTANT COVID 19 TEST KITS

Sa gitna ng ating pagresponde sa COVID 19, pinapaalalahanan ng Food and Drug Administration (FDA) ang publiko na wala pang COVID-19 point-of-care test kit o rapid test kit na aprubado ng ahensya sa ngayon. Ang mga point-of-care test kit o rapid test kit ay nagbibigay ng agaran na resulta sa ilang minuto lamang (tulad ng pregnancy test kits).

Ang mga naunang nailabas na listahan ng FDA na aprubadong COVID 19 test kits ay gumagamit ng Real Time Polymerase Chain Reaction (RT-PCR). Ito ay isang proseso na nangangailangan ng PCR Machine sa laboratoryo at mga tauhang may sapat na kaalaman sa paggamit nito.

Ang Department of Health (DOH) ay naglabas din ng pahayag sa pamamagitan ng Department Circular No. 2020-0143 ukol sa COVID-19 laboratory testing na nagsasaad na wala pang malinaw na ebidensyang susuporta sa paggamit ng lateral flow rapid (IgG/IgM) test sa pagkumpirma ng COVID 19. Ayon din sa DOH, tanging ang mga laboratoryo na nasuri ng Research Institute for Tropical Medicine (DOH-RITM) ang maaring magproseso ng mga RT-PCR based kits.

Patuloy na paiigtingin ang mga kilos ng ahensya upang makatulong sa pag sugpo sa sakit na ito. Tingnan ang FDA website para sa dagdag na detalye.

Para sa inyong kaalaman at patnubay.

Attachment:-> FDA Advisory No.2020-447

FDA Advisory No. 2020-434 || Public Health Advisory on the Purchase and Use of the Infared Thermometer for Medical Use Offered for Sale Online

The Food and Drug Administration (FDA) received reports regarding rampant online selling of the infrared thermometer for medical use in different online platforms.

A Certificate of Product Registration is required for infrared thermometers prior to distribution and sale. In view of this, FDA hereby advises all healthcare professionals and the public to purchase and use only infrared thermometer for medical use with Certificate of Product Registration (CPR) issued by FDA.

All concerned establishments are warned not to distribute, advertise, or sell unregistered infrared thermometer until a 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 only registered infrared thermometer are sold or made available in the market or in their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of unregistered above-mentioned medical device 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) 8857-1900 loc. 8301.  

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-434

FDA Advisory No. 2020-178 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Alaris® Secondary Syringe Adapter”

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. “Alaris® Secondary Syringe Adapter”

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, 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.2020-178

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-178 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Alaris® Secondary Syringe Adapter”

FDA Advisory No. 2020-177 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “MEDX Cervical Brush”

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. “MEDX Cervical Brush”

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, 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.2020-177

FDA Advisory No. 2020-157 || Voluntary Recall of Unisepta Foam 2 Medical Device Disinfectant 750ml

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public on the voluntary recall of Unisepta Foam 2 Medical Device Disinfectant 750ml with MDR No. 06986, imported and distributed by Dental Domain:

Product Name

Lot Number

Unisepta® Foam 2 Medical Device Disinfectant 750ml A08702S
A21511S
A31010S
B10630S

Dental Domain has conducted the voluntary recall of the aforementioned product due to the announcement from their supplier, USF Healthcare. According to their supplier, a contamination with gram negative bacteria Burkholderia Capacia commonly found in water has been identified in the manufacturing process of the affected products at their subcontractor. The bacteria pose little medical risk to healthy people. However, immunocompromised patients are at higher risk of infection. They have moved to test their products to ensure the safety and decontamination of the manufacturing facilities has been done.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the said medical device.

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

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

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at cdrrhr@fda.gov.ph, or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-157

FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Volumetric Solution Infusion Set. Please see particulars/details of the original vs. the counterfeit product  on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

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

All concerned establishments are warned not to distribute, the said counterfeit medical device.

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 violative 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 this counterfeit 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) 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.2020-158

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

FDA Advisory No. 2020-156 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Inset Adult without Needle”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Inset Adult without Needle. Please see particulars/details of the original vs. the counterfeit product on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

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

All concerned establishments are warned not to distribute, the said counterfeit medical device.

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 violative 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 this counterfeit 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) 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.2020-156

FDA Advisory No. 2020-122 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Doc Check® – Nebulizer Mask”

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. “Doc Check® – Nebulizer Mask”

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) 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. 2020-122

FDA Advisory No. 2020-121 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

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. We Bare Bears Adhesive Bandage/Plaster
  2. First Aid – Breathable & Waterproof Adhesive Bandage/Plaster (40 count)
  3. First Aid – Breathable & Waterproof Adhesive Bandage/Plaster (50 count)

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 these unregistered medical devices have not gone through evaluation process of the FDA, the agency cannot assure their 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 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 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) 857-1900 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. 2020-121

FDA Advisory No. 2020-055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Condoms 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. Condoms in foreign characters

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 these unregistered medical devices have not gone through evaluation process of the FDA, the agency cannot assure their 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 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 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]da.gov.ph, or call (02) 857-1900 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:-> FDAAdvisory No.2020-055

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Condoms in foreign characters”

FDA Advisory No. 2020-054 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Whiter Smile Home Teeth Whitening Kit”

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. Whiter Smile Home Teeth Whitening Kit”

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, 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.2020-054

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-054 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Whiter Smile Home Teeth Whitening Kit”

FDA Advisory No. 2020-053 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “MC-246 Digital Pencil Thermometer”

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

  1. “MC-246 Digital Pencil Thermometer”

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 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 from FDA is prohibited.

Accordingly, since this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device 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.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-053

FDA Advisory No. 2019-527 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Bio Swiss Cupcake Shaped Bandage”

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

  1. BIO SWISS CUPCAKE SHAPED BANDAGE

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 their 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) 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.2019-527

FDA Advisory No. 2019-526 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Care Touch Oral Medicine Syringe”

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

  1. “CARE TOUCH ORAL MEDICINE SYRINGE”

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 their 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) 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.2019-526

FDA Advisory No. 2019-525 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Surgitech Clinical Fieber Thermometer MT-101”

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

  1. “SURGITECH CLINICAL FIEBER THERMOMETER MT-101”

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 their 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) 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.2019-525

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-525 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Surgitech Clinical Fieber Thermometer MT-101”

FDA Advisory No. 2019-524 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Qinlishu Flex Freely Abacterial Flexible Fabric Bandage”

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

  1. “Qinlishu Flex Freely Abacterial Flexible Fabric  Bandage”

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 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 from FDA is prohibited.

Accordingly, since this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device 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.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2019-524

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-524 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Qinlishu Flex Freely Abacterial Flexible Fabric Bandage”

FDA Advisory No. 2019-523 || Voluntary Recall of Endo GIA Articulationg Reload with Tri-Staple Technology

The Food and Drug Administration (FDA) warns all healthcare professional and the general public on the voluntary recall of Endo GIA Articulating Reload with Tri-Staple Technology with MDR No. 00768, imported and distributed by Medtronic Philippines Inc.:

Product Name Product Code Lot Number
Endo GIA Articulating Reload with Tri-Staple Technology EGIA60AMT N5G0186KX
N5J0492KX
N5J0775KX
N5M0769KX
N5M0582KX
N6C0972KX
N6E0462KX
N6E0600KX
N6F0541KX

Medtronic Philippines Inc. has conducted the voluntary recall of the aforementioned product due to the potential absence of one of the two pin components that maintains the alignment of the device jaws. This potential issue was identified during the in-process quality testing at the manufacturing facility. The use of a product with missing pin may result in incomplete staple formation. This may cause bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. Manufacturing process improvements have been implemented to address this issue. There have been no confirmed complaints associated with this recall.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the said medical device.

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

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

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

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.2019-523

FDA Advisory No. 2019-522 || Public Health Warning Against the Purchase and Use of Unregistered Medical Devices that is being Advertised and Offer for Sale Online

to continue reading, click the attachment below…

Attachment:-> FDA Advisory No.2019-522

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-522 || Public Health Warning Against the Purchase and Use of Unregistered Medical Devices that is being Advertised and Offer for Sale Online

FDA Advisory No. 2019-521 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Ethicon* Mersilk* Black Braided Silk Suture N537”

to continue reading, click the attachment below…

Attachment:->FDA Advisory No.2019-521

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-521 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Ethicon* Mersilk* Black Braided Silk Suture N537”
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