The Philippines medical device market is continuously growing.
To enter the medical device market, you must report and register medical devices with the Philippines Food and Drug Administration (FDA).
According to the 2018-0002 (Medical Device Registration Requirements), medical devices are classified according to risk, and other procedures and renewals are required.
Philippines medical devices are divided into 4 categories according to risk.
- Class A – Low risk (Mask, etc)
- Class B – Low-Moderate risk (Diagnostic Medical Device, etc)
- Class C – Moderate-High risk (Implant, etc)
- Class D – High risk (Artificial Heart, etc)
Class A is subject to report (Certificate of Medical Device Notification (CMDN)) / Class B, C, D are subject to registration (Certificate of Medical Device Registration (CMDR)), and the validity period is 5 years.
In addition, the Philippines must obtain an Operational License (LTO) for medical device manufacturers, traders, distributors, importers, exporters or wholesalers.
Please refer to the Philippines Food and Drug Administration (FDA) website below.
Home - Food and Drug Administration
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www.fda.gov.ph
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