Philippines FDA Issues New Guidance for Vet Products
The Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.
Charmaine joined Asia Actual in 2015 as the Principal Consultant of Asia Actual in Manila. Charmaine is one of the most experienced regulatory affairs professionals in the country with more than 500 successful medical device application approvals to her credit. Prior to Asia Actual, Charmain spent more than 15 year leading medical device registration operations for multinational companies such as Terumo, Becton Dickinson, Baxter Healthcare and B. Braun.
Charmaine holds a BS degree in Pharmacy from Centro Escolar University and maintains certification as a Philippines FDA Qualified Person in Industry for medical devices, drugs and vaccines. Charmaine is one of the founders and officers of the Philippine Association of Medical Device Regulatory Professionals (PAMDRP) and is active as a medical mission volunteer to depressed areas of the Philippines.
The Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.
The Philippines FDA released a draft Circular announcing an extension of the grace period for certain medical devices by 12 months.
The Philippines FDA released new draft IVD guidance for the public’s review and comment in early January 2022 which would harmonize their regulations with the ASEAN Medical Devices Directive (AMDD).
Products approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.
the FDA has released a list of Class A 1,242 product categories in Circular 2021-017 on August 16, 2021. Medical device manufacturers of Class A products specified in Annex A or under the ASEAN MDD, must obtain a Certificate of Medical Device Notification (CMDN).
During this transition period, Class B, C, and D medical devices that are not included in the specified list in Circular No. 2021-001-A may continue to be manufactured, imported/exported, distributed, and/or sold without a CMDN until March 31, 2022.
Notification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.
At this time Indonesia’s Ministry of Health will only regulation Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.
On January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.
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