Classification Overview
FDA Philippines / CDRRHR · ASEAN AMDD · Class A · B · C · D
Four-Class Risk System — ASEAN AMDD
The Philippines uses the ASEAN Medical Device Directive (AMDD) four-class risk classification:
| Class | Risk Level | Certificate | Examples |
|---|---|---|---|
| A | Low | CMDN (Notification) | Bandages, examination gloves (non-sterile), tongue depressors, simple non-invasive accessories |
| B | Low-moderate | CMDR (Registration) | Hypodermic needles, blood pressure monitors, non-implantable patient monitoring |
| C | Moderate-high | CMDR (Registration) | Infusion pumps, ventilators, bone fixation plates |
| D | High | CMDR (Registration) | Heart valves, pacemakers, coronary stents, active implants |
Classification Rules
Classification follows ASEAN AMDD principles based on:
- Intended purpose — as stated by the manufacturer; the starting point for classification
- Invasiveness — non-invasive, orifice-invasive, surgically invasive, implantable
- Duration of contact — transient (< 60 min), short-term, long-term (>30 days)
- Active vs non-active — energy-dependent devices classified higher at equivalent invasiveness
- Anatomical location — CNS, cardiovascular, or blood-stream contact = higher risk
Tie-breaking: Where multiple rules apply, the highest class determined by any applicable rule governs.
IVD Classification — Current Philippines Status — PH-Unique
IVD classification exists within the ASEAN AMDD framework (IVD Class A–D), but as of May 2026:
- IVDs are NOT required to obtain CMDN or CMDR registration in the Philippines
- IVD classification rules exist for when registration requirements are eventually implemented
- LTO is still required for entities importing or distributing IVDs
Monitor the CDRRHR website for the announcement of IVD registration implementation — see IVD Registration Update.
Product Classification Inquiry — PH-Unique
The CDRRHR provides a product classification inquiry process for manufacturers and importers who are uncertain of their device's class or whether their product meets the device definition:
- Prepare a written classification inquiry letter including:
- Full device description
- Intended purpose
- Materials
- Manufacturer information
- Submit to CDRRHR
- CDRRHR provides a written classification determination
The Food and Drug Action Center at the FDA Philippines main office also provides walk-in assistance for classification queries.
Always seek a formal classification determination before investing in registration preparation if there is any doubt about whether a product is a medical device, what class it falls in, or whether it should be handled by CDRRHR vs another FDA center.
CDRRHR List of Registrable Medical Devices
CDRRHR publishes a list of medical devices subject to registration (CMDN/CMDR). Not every instrument or product with a health-related claim meets the regulatory definition of a medical device. Confirm your product appears on or is consistent with the registrable devices list before proceeding.
Monitor the official CDRRHR announcements and FDA Philippines website for updates on IVD registration implementation timeline. As of May 2026, no final implementation date has been announced. Entities distributing or importing IVDs should maintain compliance with all other applicable regulations and ensure valid LTO status in the interim.