The Philippines FDA issued Circular no. 2021-002 on 4th January 2021, which contains the implementation schedule of the Administrative Order No 2018-002: “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” over three (3) phases.
Section IX of Administrative Order (AO) no. 2018-002 stipulates that the requirement of registration for all medical devices not indicated in the list of registrable medical devices shall be implemented in phases and that the schedule of implementation shall be issued in separate memoranda.
The phases are listed in Circular No 2021-002 as follows:
1. Phase 1: Notification of Class B (low-moderate risk), C (moderate-high | risk)-and D (high risk) that are non-registrable medical devices based: on FDA Memorandum Circular (MC) No. 2014-005. FDA MC 2014-005 was
superseded by the list of medical devices in Annex A of FDA Circular No. 2020-001 entitled “Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a
Medical Device Based on the ASEAN Harmonized Technical Requirements”
2. Phase 2: Registration of Class D (Notification of Class D shall cease during this phase)
3. Phase 3: Registration of Class B and Class C (Notification of Class B and C shall cease during this phase)
Circular no. 2021-002 has following guidelines:-
1. The Center for Device Regulation, Radiation Health, and Research shall be accepting applications for CMDN for Class B, C and D medical devices that are not included in the list of medical devices in Annex A of FDA Circular No. 2020-001 and its subsequent amendment(s) upon the effectivity of this Circular.
2. The filing of an application for CMDN for Class B, C, and D medical devices shall follow the existing procedure for filing an application for CMDN for Class A medical devices.
3. The CMDN for Class B, C, and D medical devices shall be valid for two (2) years.
4. Three (3) months prior to the expiration of the CMDN, the company shall apply for a CMDR for the product. Application for CMDR for Class B, C and D medical devices covered in this Circular shall follow the existing CMDR policies and procedures.
5. Classification of medical devices that are not included in Annex A of FDA Circular No. 2020-001 and its amendment(s) shall follow the classification rules of AMDD as stated in item 2, Section V. General Guidelines of AO 2018-0002.
6. The applicant shall submit the legal and technical requirements specified in Annex A and Annex B, respectively, of AO 2018-0002 when applying for CMDN for Class B, C and D medical devices covered in this Circular.
7. The fee for CMDN shall be P3,000.00 and an additional 1% thereof for the Legal Research Fee (LRF). This LRF imposition is pursuant to FDA Circular No. 2011-003 or the “Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended by PD 1856”.
8. The fee for the CMDR shall be in accordance with the existing fees during the time of the application.
Please refer to the FDA Circular No. 2021-002 || Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements https://www.fda.gov.ph/fda-circular-no-2021-002-full-implementation-of-administrative-order-no-2018-0002-entitled-guidelines-governing-the-issuance-of-an-authorization-for-a-medical-device-based-on-the-aseab-h/
Circular on medical device product standards
The Philippines FDA issued Circular no. 2021-001 on 4th January 2021 on hierarchy of Product Standards for medical devices to be compiled for notification or registration purposes.
Part of the CSDT is the submission of the Declaration/Certificates of Conformity (self-declaration by the manufacturer) with product standards for all classes (Class A, B, C, and D) of the medical devices.
Circular No 2021-001 guides the local manufacturer, importer, and/or distributor of the product standards to refer to and comply with prior to applying for a Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR) for their medical device product. The following hierarchy of product standards shall apply:
- Philippine National Standard (PNS)
- ISO Standard or IEC standard (whichever is applicable) in the absence of PNS
- Standard developed by other International Standard Bodies recognized by the Department of Health (DOH) in the absence of PNS, ISO Standard or IEC standard
- Any foreign standard that may be recognized by the DOH for the purpose of registration in the absence of PNS, ISO standard, IEC standard or standard developed by other International Standard Bodies recognized by the DOH.
All medical devices either imported or manufactured locally that do not comply with any of the above-specified standards shall not be issued with a CMDN or a CMDR.
This Circular shall take effect immediately and shall remain valid unless otherwise revoked, repealed, or rescinded.
Link: FDA Circular No. 2021-001 || Hierarchy of Product Standards for Medical Devices to be Complied with for Notification / Registration Purposes https://www.fda.gov.ph/fda-circular-no-2021-001-hierarchy-of-product-standards-for-medical-devices-to-be-complied-with-for-notification-registration-purposes/