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:

1. Intended purpose — as stated by the manufacturer; the starting point for classification
2. Invasiveness — non-invasive, orifice-invasive, surgically invasive, implantable
3. Duration of contact — transient (< 60 min), short-term, long-term (>30 days)
4. Active vs non-active — energy-dependent devices classified higher at equivalent invasiveness
5. 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:

1. Prepare a written classification inquiry letter including:
   • Full device description
   • Intended purpose
   • Materials
   • Manufacturer information
2. Submit to CDRRHR
3. 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.