This issuance aims to provide information regarding the acceptance of applications based on AO 2018-0002, validity of issued Certificate of Exemption (COE), and application fees for identified marketing authorizations. This shall guide establishments engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and where applicable, the use, testing, promotion, advertising, or sponsorship of medical devices. This Circular also aims to provide guidance for the medical device industry and all concerned regarding the classification of medical devices listed in FDA Memorandum Circular No. 2014-005 and FDA Memorandum Circular No. 2014-005-A.
POLICIES AND GUIDELINES
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) shall be accepting applications for the following marketing authorizations a. Certificate of Medical Device Registration (CMDR) for medical devices with risk classification of B, C, and D which are included in FDA Memorandum Circular 2014-005 and 2014-005-A (see annex A). b. Certificate of Medical Device Notification (CMDN) for all medical devices with risk classification A whether or not included in FDA Memorandum Circular No. 2014-005 and FDA Memorandum Circular No. 2014-005-A. c. Certificate of Medical Device Listing (CMDL) for research, clinical trial, exhibit, personal use and/or donated, brand new medical devices.
To access FDA Circular No. 2020-001, please download ATTACHMENT 1.
Source: Philippines FDA
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