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: In the Philippines, medical devices are regulated by Food and Drug Administration (FDA) under the Department of Health.
Medical devices are divided into four classes (1, 2, 3, and 4) based on risk level.
The approval process takes 6-8 months.
Licenses issued in the Philippines expire after one year.
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.
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