Medical device regulation in the Philippines is overseen by the Department of Health’s Center for Device Regulation, Radiation Health, and Research (CDRRHR) as well as the Bureau of Food and Drugs (BFAD). Regulators in the Philippines are currently developing more substantive requirements for medical devices; for now, only specific devices are subject to mandatory registration. Devices not required to register may be sold after obtaining a Certificate of Exemption from the Department of Health.
Let Emergo assist you in evaluating the Filipino medical device regulatory framework as it applies to your device(s)
Emergo's worldwide network of consultants, industry contacts and regulatory sources allows us to provide incisive analysis of multiple medical device markets, including the Philippines.
Our Global Regulatory Overview report service on the Philippines provides in-depth coverage of the following topics:
- CDRRHR and BFAD Regulatory Background
- Product Assessment
- Authorized Representation Issues in the Philippines
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for the Philippines