Regulatory Updates

On 27 September 2022, the Philippines FDA issued FDA Circular No. 2022-008 which aims to provide guidelines on the abridged processing of application for registration of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements. This Circular shall apply to Class

The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration In Light Of The Extended State Of Public Health Emergency” The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration

On September 9, 2022, the Philippines FDA issued FDA Circular No 2022-007 that provides guidelines on the use of the FDA e-Services Portal System for the LTO Application of Medical Device Retailers. The FDA e-Services Portal System has been developed and updated to provide a streamlined online platform for FDA

On September 6 2022, The Philippines FDA issued FDA Advisory No. 2022-1576 to transfer the product registration of alcohol swab with 70% isopropyl alcohol from the CDRRHR to the CDRR. Alcohol swab with minimum concentration of 70% isopropyl alcohol are within the jurisdiction of the CDRR under Household Remedy Products.