Food and Drug Administration (FDA) Philippines - CDRRHR

The Center for Device Regulation, Radiation Health, and Research (CDRRHR) is the specialized branch of the Philippine FDA responsible for the regulation of medical devices, ensuring they meet national standards for safety, quality, and efficacy.

1. Regulatory Role

Under Republic Act No. 9711, the FDA mandates that all medical device establishments must obtain a License to Operate (LTO) and register their products before they can be legally distributed in the country.

2. Licensing of Establishments (LTO)

The provided eServices portal facilitates the application for the LTO. This license is required for:

• Manufacturers
• Traders
• Distributors (Importers, Exporters, and Wholesalers)

3. Product Classification and Registration

In alignment with ASEAN Harmonized Templates, the Philippines classifies devices based on risk:

• Class A (Low Risk): Requires a Certificate of Medical Device Notification (CMDN).
• Class B (Low-Moderate Risk): Requires a Certificate of Medical Device Registration (CMDR).
• Class C (Moderate-High Risk): Requires a CMDR.
• Class D (High Risk): Requires a CMDR.

4. Digital Transformation (eServices)

The FDA has transitioned to an online platform for LTO applications to streamline the process, reduce manual paperwork, and enhance transparency in the regulatory pipeline.