A list of recently published and updated articles regarding medical device regulatory updates from the PFDA and other governing bodies in the Philippines.

Philippines Issues Guidance on Medical Device Labeling

On April 5th, the CDRRHR provided guidance for CMDR medical device labeling in the Philippines related to previously CMDN labeled stock.

Philippines FDA Extends CMDN Deadline to 2024

The Philippines Center for Device Regulation, Radiation Health and Research (CDRRHR) has announced that Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to September 30, 2024.

Philippines Incentivizing Local Medical Device Manufacturing

On March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.

Philippines FDA Bans Mercury-Added Products

Released on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.

What is CSDT Documentation?

Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”

Philippines FDA Announces New Fee Schedule for Medical Devices

On November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes.

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 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 FDA to Implement New Guidelines to Respond to Future National Health Emergencies

The Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.”

Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices

On December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).