Philippines FDA issues implementation schedule of AO 2018-002
The Philippines FDA issued Circular no. 2021-002 on Monday 4th January 2021, which contains the implementation scheduleof 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.
Administrative Order (AO) no. 2018-002 section IX stipulates that the requirement of registration for all medical devices not indicated in the list of registrable medical devices (Annex A of Circular no. 2020-001) shall be implemented in phases and that the schedule of implementation shall be issued in separate memoranda.
Circular No 2021-002 lists the three phases, as follows:
Phase 1:Non-registrable Class B, C and D medical devices (i.e., they are not listed in Annex A of Circular no. 2020-001) must apply for a Certificate of Medical Device Notification (CMDN).
Nota bene: Annex A of Circular no. 2020-001 lists those medical devices which are required to be registered with the FDA. This list has now been updated and can be accessed here.
Phase 2:All Class D medical devices must apply for a Certificate of Medical Device Registration (CMDR). Please note that CMDNs of Class D medical devices shall cease during this phase.
Phase 3:All Class B and C medical devices must apply for a CMDR. Please note that CMDNs of Class B and C medical devices shall cease during this phase.
As expected, the Philippines should move into Phase 1 once Circular no. 2021-002 becomes effective at some point in the first quarter of 2021; this circular shall take effect fifteen (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. Follow our Linkedin page to remain informed.
Circular no. 2021-002 provides the following guidelines to medical device manufacturers, traders, importers, distributors and concerned parties:
- The Center for Device Regulation, Radiation Health and Research (CDRRHR) shall accept CMDN applications for non-registrable Class B, C and D medical devices once Circular no. 2021-002 becomes effective.
- Filing for CMDN application of Class B, C and D medical devices shall follow the existing procedure of filing for CMDN application of Class A medical devices.
- CMDN for Class B, C and D medical devices will have a validity of two (2) years
- Companies shall apply for a CMDR for the concerned product three (3) months prior to expiration of the CMDN. Application for CMDR of Class B, C and D medical devices covered in this Circular shall follow the existing CMDR policies and procedures.
- 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 the AMDD as reiterated in item 2, Section V. General Guidelines of Administrative Order no. 2018-0002.
- 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.
- The fee for CMDN shall be ₱3,000.00 (three thousand Philippine Peso) plus an additional 1% for Legal Research Fee (LRF).
- The fee for the CMDR shall be in accordance with the fees at the time of application.
The full circular can be read here.
If you would like more information about this important regulatory change impacts your market access or are interested in registering your medical device in the Philippines please send us an email to [email protected]