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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
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