《药品管理法》为什么管得住医疗器械：1996 年法第 8 条与 2007 年修正法

1. Key Takeaway

Cambodia brings medical devices under unified “pharmaceutical” regulation through a clear legal chain: Article 8(1) of the 1996 Law on the Management of Pharmaceuticals lists four matters requiring Ministry of Health authorisation; Article 8 (new), paragraph 2, as revised by the 2007 Law on the Management of Pharmaceuticals (Amendment) (Royal Kram No. NS/RPhM/1207/037), further provides that importing, distributing and displaying pharmaceuticals and all kinds of cosmetics for sale in Cambodia requires a registration number from the Cambodian Ministry of Health. It is through this provision that devices are brought into the pharmaceutical-style registration and licensing framework.

Article 4 (new) of the same amendment resolves another key question: it permits any person, regardless of gender and whether Cambodian or foreign, to operate pharmaceutical manufacturing enterprises, import and export enterprises and pharmaceutical trading, but requires that technical production, storage, distribution and wholesale be handled, and the responsibility borne, by a technical pharmacist who holds Cambodian nationality, a pharmacy diploma recognised by the Ministry of Health and a clean criminal record, is in good health, and is a member of the Pharmacy Council of Cambodia.

GRZAN note: the 1996 Law has 15 articles in total and the 2007 amendment revises 7 of them (Articles 2, 4, 8, 9, 10, 12 and 13); Article 8 (new), paragraph 1 lists 4 licensable matters, and paragraph 2 establishes the registration number requirement.

2. Regulatory Basis

3. Expert Commentary

1. The 1996 Law’s definition of “pharmaceutical” does not directly cover devices; what does the work is the 2007 amendment. Article 2 of the 1996 Law defines pharmaceuticals as “substances” used to prevent or treat disease in humans or animals, used in medical or pharmaceutical research and diagnosis, and used to modify or support organ functions — wording that points to drugs, not devices. Devices are brought in by the registration number requirement of the newly inserted Article 8 (new), paragraph 2 of the amendment, together with the chain of rules formed by Article 7 empowering the Ministry of Health to elaborate procedures by Prakas. Searching only the original 1996 text produces the wrong conclusion that “devices are unregulated”.

1. Article 4 (new) of the amendment is both the key to foreign investment and a staffing threshold. It opens operating eligibility to foreign nationals — a substantive liberalisation aimed at attracting foreign investment; but it immediately requires the technical operations to be handled by a Cambodian registered pharmacist who must be a member of the Pharmacy Council of Cambodia. This means that even with 100% foreign ownership, an investor must resolve a local staffing qualification that cannot be substituted by personnel from abroad.

1. A “registration number” and a “registration certificate” are not the same thing, and neither equals the right to import. Article 8 (new), paragraph 2 of the amendment uses “registered number”, which addresses product-level access; item 3 of Article 8 (new), paragraph 1 separately lists “import of pharmaceuticals, raw materials, packaging materials and pharmaceutical machinery” as a matter requiring authorisation. The product needs a registration number and the entity needs an import and export licence; the two are parallel conditions.

4. Practical Recommendations

1. Front-load the pharmacist question at the entity-structure design stage. Whether the route is a local entity or a designated local representative, verify that the counterpart employs a member of the Pharmacy Council of Cambodia whose membership is current. Until this item lands, no downstream submission can start.
2. Manage “registration number / import-export authorisation / shipment-by-shipment import licence” as three separate items. They rest on different legal bases, are handled by different parties and fall at different points in time; managing them jointly leads to gaps suddenly surfacing at customs clearance.
3. Stay alert to Articles 10, 12 and 13 as revised by the 2007 amendment. The amendment does revise the penalty provisions, but publicly readable text of the revised provisions has not been obtained. For penalty risk assessments, work from the current text and mark the items “to be verified” in deliverables.

5. Verification Checklist

• □ Obtained the original 1996 Law on the Management of Pharmaceuticals and located each item of Article 8
• □ Obtained the 2007 amendment (Royal Kram NS/RPhM/1207/037) and located Article 8 (new), paragraph 2
• □ Confirmed the amendment’s scope is limited to Articles 2, 4, 8, 9, 10, 12 and 13
• □ Verified the local entity’s pharmacist is a member of the Pharmacy Council of Cambodia
• □ Product registration number, import-export authorisation and shipment-by-shipment import licence listed as three separate milestones
• □ External documents touching penalty provisions marked “subject to the current text”

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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