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.

Philippines Extends Grace Period for Registration of Certain Medical Devices

The Philippines FDA released a draft Circular announcing an extension of the grace period for certain medical devices by 12 months.

Philippines FDA to Expedite Applications Approved Under AMDD-CSDT

Products approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.

PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

Philippines FDA Issues New Draft IVD Regulations

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).

Philippines Announces New PEMDL Essential Medical Device List

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.

Philippines Extends Grace Period for Non-Notified Class B, C, and D Medical Device Registration

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.

Philippines Releases New Guidance on Class A Medical Devices

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).

The Philippines FDA Releases List of VAT Exempt Therapeutic Products

On September 14th, the Philippines FDA released FDA Advisory No.2021-2293, outlining the list of VAT-Exempt Products pursuant to Republic Act No. 11534, otherwise known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act.”

The Philippines FDA Issues Guidance for Retailers of Medical Devices

On October 7, 2021, the Philippines FDA released FDA Circular No.2021-0021. The new regulations apply to establishments that provide medical devices Direct to Consumers (DTC) including pharmacies and eCommerce storefronts.