Philippines FDA consults industry on Class A Medical Devices List
The Philippines Food and Drug Administration (FDA) recently released a draft for comments on the List of Class A Medical Devices for FDA registration in the Philippines.
The List of Class A Medical Devices helps medical device industry stakeholders to determine the appropriate risk classification of their device in order to apply for the correct market authorization; in this instance to apply for a Certificate of Medical Device Notification (CMDN).
A CMDN is the required marketing authorization certificate for all medical device products that are classified as Class A products. In other words, if a medical device is on the List of Class A Medical Devices, then a CMDN should be applied for.
The draft for comments proposes the following:
- Clients shall apply for a CMDN prior to executing activities (manufacture, distribution, import/export, sale, offer for sale, promotion, advertising) for Class A medical devices listed in Annex A
- If a product is not included in the list, then the classification shall be based on its intended use and the classification rules of the ASEAN Medical Device Directive (AMDD). The FDA’s Centre for Device Registration, Radiation, Health and Research (CDRRHR) will verify the classification made by the applicant and reclassify, if necessary.
- The classification of medical devices listed in ANNEX A of the draft will be subject to change if there are any additional indicated uses, claims or changes in the duration of use of the product. Any new classification of the medical device shall follow the classification rules of the AMDD.
- The new guidelines shall take effect fifteen (15 days) following the publication in a newspaper of general circulation and upon filing three (3) certified copies to the University of the Philippines Law Center.
- ANNEX A; the current draft list of Class A medical devices can be found in Annex A of the draft for comments.
Implications for medical device manufacturers and distributors
Medical device manufacturers and distributors should contact the FDA CDRRHR if they have grounds for their medical device to be listed in Annex A and currently isn’t.
No details were given on how to submit comments to the FDA nor a deadline to do so.
If you would like to know how we can help you register to start selling your medical device in the Philippines, please contact us at email@example.com