分销限制：禁止网络销售与仅持牌药房可对终端销售

I. Key takeaways

Cambodia controls medical device distribution channels as strictly as pharmaceuticals, with two hard restrictions:

1. Only licensed pharmacies may sell medical devices to end consumers. Manufacturing enterprises and import-export enterprises may engage in wholesale only, may supply only licensed pharmaceutical companies, and must not sell directly to end consumers;
2. Online sale and distribution of medical devices is prohibited. The Ministry of Health has expressly banned online sales and online distribution of medical devices, consistent with the restrictions on pharmaceuticals.

In addition, only companies registered in Cambodia (holding a Certificate of Incorporation and an Import-Export Pharmaceutical Company Licence) may engage in distribution.

GRZAN note: distribution carries 2 hard constraints (online sales ban; only licensed pharmacies may sell to end users); a distributing entity must hold 2 qualifications; multiple non-exclusive importers and distributors may be appointed simultaneously (practical interpretation).

II. Legal basis

III. Expert commentary

1. These restrictions rule out several common business models outright. Direct-to-consumer e-commerce, factory-direct supply to clinics or patients, and community-marketing despatch are all non-viable in Cambodia. Channel design must start from the chain “manufacturer → licensed pharmacy → end user”, not from the shortest path to the user.

1. “Multiple non-exclusive distributors may be appointed” is one of Cambodia’s rare flexibilities. As long as the agreement between manufacturer and distributor is non-exclusive, several importers and distributors may be appointed simultaneously. This leaves room to preserve channel flexibility — note, however, that non-exclusive does not mean unmanaged: every one of them must still hold a Certificate of Incorporation and an Import-Export Pharmaceutical Company Licence.

1. The ban covers both “sale” and “distribution”, not just “retail”. The wording prohibits online sale and online distribution, which means not only B2C e-commerce to consumers but also distribution to institutions through online platforms is at risk. Online activity should be limited to product information display, and even that content must satisfy the prior advertising licence requirement discussed in article 36.

IV. Practical recommendations

1. State the “wholesale to licensed pharmacies only” obligation in channel agreements. Write this clause into every distributor agreement and require the counterparty to pass the same commitment down its downstream channels.
2. Limit online activity to information display, and secure the advertising licence first. Product pages on the corporate website, social media and e-commerce platforms can all be deemed advertising or promotion; obtain the DDF advertising licence in advance.
3. Use non-exclusive distribution to preserve channel flexibility. At launch, appoint 2 to 3 distributors simultaneously, then consolidate once actual coverage is proven, avoiding lock-in to a single channel.

V. Verification checklist

• □ Channel design follows the statutory chain “manufacturer → licensed pharmacy → end user”
• □ Confirmed that manufacturing and import-export enterprises do not sell directly to end users
• □ Online activity limited to information display, with no online sales
• □ Each distributor’s Certificate of Incorporation and Import-Export Pharmaceutical Company Licence verified
• □ Channel agreements state the “wholesale to licensed pharmacies only” obligation
• □ Non-exclusive distribution arrangement stated in the agreements

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities focus on three areas. First, tracking the legislative progress of dedicated medical device laws across member states: Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established written device regulatory frameworks, while Cambodia still has no dedicated Medical Device Law; the current rules are pieced together from three layers — the registration-number legal basis provided by the 1996 Law on the Management of Pharmaceuticals and its 2007 Amendment Law, the classification and procedures provided by Prakas No. 1258 of 2012, and the technical framework provided by the ASEAN Medical Device Directive (AMDD) — so compliance certainty is markedly lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN acts as the manufacturer’s statutory representative in Cambodia, handling registration submissions, regulatory communication and post-market reporting obligations, and helping resolve the practical issues of the Cambodian registered pharmacist and the Import-Export Pharmaceutical Company Licence. Third, quality system and testing support: establishing a quality management system conforming to ISO 13485 and organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

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