Medical Device Registration and Approval in Philippines

General country-specific regulatory information is provided on this page for medical device registration and approval in Philippines. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Philippines, to expedite the preparation of your medical device or IVD registration application.

 

Medical Device Regulations and Classification in the Philippines

REGULATORY AUTHORITY: In the Philippines, medical devices are regulated by the Philippines Food and Drug Administration (FDA) under the Department of Health.

CLASSIFICATION SYSTEM: There is currently no classification for Medical Devices in the Philippines, however, this may change with the implementation of AO2018-002.

Medical Devices: None at this time.

IVD Devices: None, general.

TIMEFRAME: The approval process takes 10-12 months for all medical and IVD devices.

SPECIAL REQUIREMENTS:

Audits: There are no audit requirements in the Philippines.

Technical Local Tests: There are no special requirements for technical local tests.

Clinical Evaluation/studies: When clinical studies are required, foreign clinical data is usually accepted.

LOCAL FEES:

Application review fees: A fee of $35 USD applies for a Medical or IVD Device.

Manufacturer registration: There are no manufacturer registration fees.

LICENSE VALIDITY: Licenses issued in the Philippines expire after one year, initially. After renewal, the license is valid for five years.

LICENSE TRANSFER: Not possible in the Philippines.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: To register a medical device, a company must have a local distributor in the Philippines registered with the Department of Health.

ADDITIONAL INFORMATION: A Certificate of Medical Device Notification (CMDN) must be obtained by a local, FDA licensed entity; the official application processing time is 180 working days (effectively 9 months). AO2018-002 (Guidelines on the documentary requirements for the registration of medical devices in the Philippines based on the provisions of the ASEAN Medical Device Directive) will be implemented as of April 11, 2019.

 

Last updated on April 11, 2019.

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, MyanmarSingapore, Thailand, Vietnam

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