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, free of charge, 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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