The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-017 on the 16th of August 2021, to guide manufacturers, importers, distributors, and other stakeholders in the medical device industry regarding the list of medical devices classified as Class A. The circular will also assist the industry in determining the appropriate authorization, specifically Certificate of Medical Notification (CMDN), to secure for their medical device products that fall under Class A classification.
The circular contains information on the 1,242 medical device categories that require a CMDN, which is specified in Annex A. The CMDN must be obtained prior to the manufacture, distribution, importation, exportation, sale, offer for sale, and where applicable, promotion, advertising of the Class A medical devices listed in the annex.
As stipulated in Administrative Order 2018-0002, if a product is not included in the list mentioned, an applicant shall classify the device based on the intended use and on the classification rules of the ASEAN Medical Device Directive (AMDD). The classification of medical devices listed in Annex A is subject to change if there will be additional indicated use, claim and duration of use of the product. New classification of the medical device shall follow the classification rules of the AMDD.
The Circular shall take effect fifteen (15) days following its publication in a newspaper of general circulation and upon filing three (3) certified copies to the University of the Philippines Law Center.
More details can be found in “FDA Circular No. 2021-017 Reference List of Class A Medical Devices, 16 August 2021”: https://www.fda.gov.ph/fda-circular-no-2021-017-reference-list-of-class-a-medical-devices/