The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical devices:
- KX white box (Type C, Infusion Sticker)
- 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