医疗器械定义：七项预期用途与非药理作用判据

1. Key Takeaway

Cambodia’s definition of a medical device follows the AMDD wording and covers both medical equipment and dental equipment in the same expression. A product falls within the device category only if it meets two conditions simultaneously:

(a) The intended purpose falls within the seven listed purposes — (1) diagnosis, prevention, monitoring, treatment or alleviation of disease; (2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (3) investigation, replacement, modification or support of the anatomy or of a physiological process; (4) support or sustenance of life; (5) control of conception; (6) disinfection of medical devices; (7) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.

(b) The principal intended action is not achieved by pharmacological, immunological or metabolic means, although such means may assist the device in achieving its intended function.

The scope of covered articles expressly includes: materials, equipment, instruments, tools, appliances, apparatus, implants, machines, disinfectants, in vitro reagents and calibrators, and software, together with other related products used for medical services.

GRZAN note: Cambodia’s device definition contains 7 intended purposes and 3 excluded modes of action (pharmacological, immunological, metabolic); the scope of covered articles lists 11 categories, with software and disinfectants expressly included.

2. Regulatory Basis

3. Expert Commentary

1. “Dental equipment” is written into the definition alongside “medical equipment” — a distinctive feature of Cambodia’s wording. Many markets define only “medical devices”; Cambodia lists dental equipment separately in the definitional provision and applies the same rules. Companies making dental consumables and equipment do not need a separate dental rulebook; the device pathway applies directly.

1. “Software” is expressly listed as a covered article, but there are no dedicated rules for digital health and mobile medical applications. Cambodia currently has no dedicated regulation for health information technology (digital health) or mobile medical applications; such products are handled under the general device rules. Software products in Cambodia therefore have neither an exemption from registration nor an independent simplified route; in practice they still go through A/B/C/D classification and the CSDT pathway.

1. The exclusionary wording of item (b) is the key to drawing the boundary. The decision sequence is: first check whether the intended purpose falls within the seven, then check whether the principal mode of action is excluded. For drug-device combination products, drug-eluting dressings and drug-coated stents, the judgement turns on the word “principal” in item (b): if the principal action is still physical, the product is a device; if the drug carries the principal action, the product should follow the pharmaceutical pathway — the competent procedures for the two differ completely.

4. Practical Recommendations

1. Make a written “is it a device” determination before classification. Match the product’s intended purpose against the seven purposes one by one, and record the reasoning on the mode of action as part of the executive summary of the technical dossier. If the product’s status is challenged during review in Cambodia, this determination is the first piece of evidence to submit.
2. Build separate files for software and IVDs. Software is handled as a device and IVDs are classified under Annex 3; the documentation emphasis differs from general devices, so do not force both into one template.
3. For drug-device combination products, confirm the categorisation with the local entity in advance. A wrong attribute determination sends the submission into the wrong review channel, and under Cambodia’s single-window structure there is no inter-departmental referral buffer; the cost of correction is high.

5. Verification Checklist

• □ Product attribute determination completed against the seven intended purposes, with written reasons retained
• □ Confirmed under item (b) that the principal mode of action is not pharmacological, immunological or metabolic
• □ Confirmed the product article falls within one of the 11 listed categories
• □ Software products confirmed to have no dedicated digital health rules and handled under the general device rules
• □ IVD products confirmed classified under Annex 3 rather than Annex 2
• □ Written confirmation of the categorisation of drug-device combination products obtained from the local entity

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities concentrate on three areas. First, distinguishing the legislative progress of dedicated medical device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established a written device regulatory framework, whereas Cambodia still has no dedicated Medical Device Law; its current rules are assembled from three layers — the registration-number legal basis provided by the 1996 Law on the Management of Pharmaceuticals and its 2007 amendment, the classification and procedures provided by Prakas No. 1258 of 2012, and the technical framework provided by the ASEAN Medical Device Directive — leaving regulatory certainty materially lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN can act as the manufacturer’s statutory representative in Cambodia, undertaking registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist requirement and the pharmaceutical import and export enterprise licence. Third, quality system and testing support: helping establish a quality management system meeting ISO 13485 requirements and organising the technical dossier according to the ASEAN Common Submission Dossier Template (CSDT).

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