Philippines medical device registration
How to register your medical device with the Philippines FDA
Andaman Medical is a fully licensed Local Authorized Representative for medical devices in the Philippines. We have been representing medical device manufacturers and distributors in the Philippines since 2017 including startups to medium-sized and multinational enterprises, covering all product risk classes and sectors of the medical device industry.
As your in-country representative for the Philippines, we will:
- represent your company in all dealings with the Philippines FDA and other authorities responsible for medical devices and in-vitro diagnostics
- register your product
- ensure that the medical device or IVD is correctly labelled
- import your product and maintain import records
- store and warehouse your product
- submit change notifications
- ensure post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions.
If you are still uncertain about whether your medical device will comply with the regulatory complexities in the Philippines, you can request an Intelligence Report for your product.
You can also check out our latest Insights on the Filipino market and find out more about the Philippines’ medical device market.
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We look forward to hearing from you!