Circular 2020-001 aims to provide information regarding the acceptance of applications based on AO 2018-002, validity of issued Certificate of exemption, and application fees for marketing authorizations. It also provides guidance regarding the classification of medical devices listed in FDA Memo Circular 2014-005 and 2014-005A according to the risk level.
FDA Circular 2020-001: Initial Implementation AO 2018-002: Guidelines Governing the Issuance of An Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements, was issued by the Food and Drug Administration in the late afternoon January 24, 2020.
The Circular aims to provide information regarding the acceptance of applications based on AO 2018-002, validity of issued Certificate of exemption (COE), and application fees for marketing authorizations. It also aims to provide guidance for the medical device industry and all concerned regarding the classification of medical devices listed in FDA Memo Circular 2014-005 and FDA Memo Circular 2014-005A according to the level of risk.
Specific policies and guidelines of the circular are outlined as follows:
1.) FDA CDRRHR shall be accepting applications for the following marketing authorizations:
Certificate of Medical Device Registration (CMDR) for Class B, C, and D included in the FDA Memorandum Circular 2014-005 and 2014-005A (see Annex A).
Certificate of Medical Device Notification (CMDN) for all Medical Devices with risk classification A whether or not included in FDA Memorandum Circular 2014-005 and 2014-005A.
Certificate of Medical Device Listing (CMDL) for research, clinical trial, exhibit, personal use and/or donated, brand new medical devices.
2.) Classification of Medical Devices not included in Annex A shall follow the classification rules of AMDD.
3.) All COE for Class A medical Devices issued from Feb 25, 2014 shall remain valid only until Nov 3, 2021 or within 2 years from date of effectivity of the Circular whichever is earlier.
4.) All CPR issued for Class A Medical Devices shall be deemed equivalent to CMDN only until validity of the CPR. CMDN shall be issued upon renewal of the issued CPR.
5.) Blood collection tube shall be added under the list of IVD since it has been re-classified as in-vitro diagnostic (IVD) medical devices based on definition of IVD in the ASEAN AMDD.
6.) Issuance of COE shall cease. All Class B, C and D medical devices not included in Annex A and IVD not included in FDA Memo Circular 2014-005 shall be considered non-registrable products. The License to Operate of establishment shall be provided in lieu of COE at the point of entry and/or as part of the bidding requirement.
7.) The fees shall be in accordance with AO 50s. 2001, until such time of modification, supersession, and/or revocation, with the following clarification:
a. Initial application CMDN & CMDR is Php 7,500 + 1% Legal research fee (LRF) x 5 years
b. Renewal applications of CMDN & CMDR is Php 5,000 + 1% Legal research fee (LRF)
c. Application for CMDL is Php 500 + 1% Legal research fee (LRF)
8.) Additional details shall be provided in subsequent issuances regarding the succeeding phases.
Effectivity of the circular shall take effect 15 days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the Office of the National Administrative Register.