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. INJECTION PAD (IN FOREIGN CHARACTERS
The FDA verified through post-marketing surveillance that the above mentioned medical device products are not notified and no corresponding Product Notification Certificates have 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.
Furthermore, FDA has verified that the above-stated unnotified medical device product is not imported by St. Tyke, Inc.
Additionally, with the issuance of FDA Circular No. 2020-010 entitled “Prohibition of Online Selling of Unregistered/Unnotified Medical Devices,” the FDA prohibits the online selling of medical devices and supplies without their corresponding authorizations.
All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Notification Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified 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 on the product label in the form of DVR-xxx, MDR-xxx or CMDN-xxx.
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 unnotified 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 unnotified medical device, contact the the online reporting facility eReport through e-mail at [email protected].
Dissemination of this advisory to all concerned is hereby requested.