Free Cambodia medical device classification tool

What the Cambodia classifier checks

How are medical devices classified in Cambodia?

Department of Drugs and Food uses a risk-based framework. Possible classes include Class A, Class B, Class C, Class D. Cambodia applies the ASEAN Medical Device Directive risk-class axis rather than a separate national taxonomy. AMDD Article 4(1) fixes four classes — A (low risk), B (low-moderate risk), C (moderate-high risk) and D (high risk) — with the classification rules for general devices in Annex 2 and for IVDs in Annex 3, and Article 4(6) requires a Member State that reclassifies or differs in applying those rules to notify the ASEAN Medical Device Committee with reasons. Cambodia's own implementing instrument is Prakas No. 1258 of 8 November 2012 on the Procedures for the Registration of Medical Devices, which the Department of Drugs and Food cites as the basis of the A–D framework; no official Cambodian domain publishes its text, so the national overlay is recorded in referenceSources as a located-but-unretrieved instrument and the class axis published here rests on the Directive. IVDs are classified on the same A–D axis under Annex 3, and the class is declared in the dossier the applicant files through CamPORS. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Cambodia classifier use?

Current official Department of Drugs and Food classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official Department of Drugs and Food classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.