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 Singapore

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

CLASSIFICATION SYSTEM: Medical devices are divided into four classes (1, 2, 3, and 4) based on risk level.

TIMEFRAME: The approval process takes 6-8 months.

LICENSE VALIDITY: Licenses issued in the Philippines expire after one year.

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

Last updated on March 19 2015.

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, MyanmarSingapore, Thailand, Vietnam

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