Philippine FDA and CDRRHR

The Philippine Food and Drug Administration (Philippine FDA) is the national authority for medical devices, medicines, food, cosmetics, and other health products. Its Center for Device Regulation, Radiation Health, and Research (CDRRHR) is the specialized center responsible for medical devices, in vitro diagnostics, and radiation-emitting products. Companies entering the Philippines deal with both the FDA's establishment-licensing framework and CDRRHR product authorization.

Is CDRRHR the same as the Philippine FDA?

CDRRHR is a center within the Philippine FDA, not a separate national regulator. The FDA provides the overall legal and administrative structure; CDRRHR handles device-focused evaluation and technical functions. Using “Philippines FDA,” “Philippine FDA,” or “CDRRHR” without context can cause confusion, so regulatory documents should identify the specific center and transaction.

How are medical devices classified in the Philippines?

The Philippines uses Classes A, B, C, and D, progressing from low to high risk under an ASEAN-aligned approach. Classification affects whether a product requires notification or registration and how much evidence is reviewed. The intended use, invasiveness, duration, active features, and IVD rules should be assessed before filing.

What are CMDN and CMDR?

A Certificate of Medical Device Notification (CMDN) is the product authorization used for qualifying Class A devices. A Certificate of Medical Device Registration (CMDR) is used for Classes B, C, and D. Since March 10, 2025, the FDA has directed initial Class A CMDN applications through its eServices Portal. Manufacturers should verify current transitional notices and portal instructions for each application type.

Does a foreign manufacturer need a local company?

An overseas manufacturer generally appoints a licensed Philippine establishment, such as an importer, to submit and hold the authorization. The local company must have the applicable License to Operate before the product application. Its responsibilities can include authority correspondence, importation, distribution records, vigilance, recalls, and renewal or change submissions.

What documentation is commonly required?

The dossier can include an ASEAN Common Submission Dossier Template, device description and intended use, classification, authorization letters, quality-system and conformity evidence, labeling and instructions, risk-management files, and performance or clinical evidence. The exact package and review depth depend on the class and device.

How do I contact the Philippine FDA or CDRRHR?

Use the Philippine FDA website and current advisories for official portal and service information. The agency lists info@fda.gov.ph for general inquiries and cdrrhr.lrd@fda.gov.ph for CDRRHR licensing and registration concerns.

Related Philippines regulatory topics

See our Philippines medical device registration overview for the practical licensing and product-authorization sequence.