The Food and Drug Administration (FDA) of the Philippines released FDA Circular 2021-002-C on 29 March 2023 for the regulatory flexibility guidelines for Class B, C, and D medical devices that are not included in the registerable medical devices list.
FDA issued the FDA Circular 2021-002-B on 21 April 2022, amending the previous FDAC 2021-002-A by extending the date for manufactured, imported/exported, distributed, transferred, sold, or offered for sale without CMDN until 31 March 2023, directly revoking the section V (1) of FDA C 2021-002-A. Hence, all manufacturers, importers, and traders must secure the Certificate of Medical Device Registration (CMDR) starting from 1 April 2023.
A disruption in the market's supply of medical devices could result from the complete execution of the circulars, which could have an impact on healthcare services. Thus, in accordance with Administrative Order No. 2018-0002 (AO 2018-00002), the FDA offers regulatory flexibility guidelines to help businesses prepare technical documentation that complies with the ASEAN CSDT criteria.
The Regulatory Flexibility guidelines are:
Previously in November 2014, the Philippines agreed on the harmonized medical device regulations and common technical documents so that only those that conform to the provisions of the ASEAN agreements on the Medical Device Directive may be placed on the market of the Member State. Hence, on 26 January 2018, the Department of Health released Administrative Order No. 2018-0002 (AO 2018-00002) to provide guidelines on the registration documentation requirements for the medical devices listed by the Centre for Device Regulation, Radiation Health, and Research (CDRRHR) to align with the AMDD CSDT requirements.
Meanwhile, the AO also mentioned the non-listed medical devices registration requirements and the implementation schedule shall be done in phases:
(Note: All Class B, C, and D medical devices and in-vitro diagnostic (IVD) devices that are not included in FDA Memorandum Circular No. 2014-005 shall considered as non-registrable products)
Through the FDA Circular 2021-002-A, all Class B, C, and D medical devices that are already in the market are allowed to continue the activity of manufacturing, import/export, distribution, transferring, selling, or offering for sale without CMDN until 31 March 2022 and must secure an approved or pending CMDN application by 1 April 2022. However, this issue has been superseded by FDA Circular 2021-002-B.
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