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

Philippines Incentivizes Local Medical Device Manufacturing

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July 31st, 2024: Philippines established its first inaugural Pharma-Med Development Hub, which will contribute to local medical development.

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What is CSDT Documentation?

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

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Philippines Issues Guidance on Medical Device Labeling

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

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Philippines FDA Extends CMDN Deadline to 2024

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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.

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Philippines Incentivizing Local Medical Device Manufacturing

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

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Philippines FDA Bans Mercury-Added Products

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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.

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Philippines FDA Announces New Fee Schedule for Medical Devices

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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.

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Philippines FDA to Expedite Applications Approved Under AMDD-CSDT

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

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Philippines FDA Issues New Draft IVD Regulations

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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).

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

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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.”

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