谁可以做持证人：境外厂商能做持证人，但不能做申请人

I. Key takeaways

Cambodia has adopted a separated design between “whose name appears on the certificate” and “who is entitled to submit”:

• Licence holder and manufacturer: may be an overseas entity. The Department of Drugs and Food (DDF) allows a foreign manufacturer or product owner to be named as the licence holder and manufacturer on the registration certificate;
• Applicant: must be a locally licensed Cambodian company, and that local company must employ a Cambodian registered pharmacist.

An overseas entity therefore has only two implementation routes: establish a local entity, or appoint a local representative. Whichever route is chosen, submission and accountability rest with a local company.

GRZAN note: Cambodia separates 2 identities — the licence holder and manufacturer may be overseas entities (2 identities), while the applicant must be a local company (1 entity); there are 2 implementation routes in total.

II. Legal basis

III. Expert commentary

1. This separated design gives overseas manufacturers significant commercial flexibility. Once the certificate is obtained, the licence holder can in principle switch the local company that actually imports and distributes without re-registering the product. This is valuable for manufacturers that want to preserve channel flexibility — provided that the local entity handling submission and the licence-holding rights are clearly separated in the letter of authorisation (see article 16).

1. “The licence holder may be an overseas entity” does not mean that an overseas entity can bear all obligations on its own. Article 1.2 of the AMDD places the registration obligation on both the product owner and the authorised representative; the post-market obligations in Article 12 also require a contactable responsible person in the territory. Naming an overseas entity as licence holder solves the “ownership” question but not the “contact channel” question.

1. In practice, the more robust arrangement is “overseas manufacturer as licence holder plus an independent third-party authorised representative”. Under this structure the registration certificate is unaffected when the distribution network changes. If a single importer serves simultaneously as licence holder, applicant and distributor, ownership and handover of the registration certificate become complicated once the cooperation ends.

IV. Practical recommendations

1. State the three identities separately in the letter of authorisation. Licence holder (overseas manufacturer), manufacturer (overseas manufacturer), and applicant and local authorised representative (local company): list the rights, obligations and termination conditions of each in separate clauses.
2. Prefer the independent third-party authorised representative model. For companies planning multi-brand, multi-channel operations, separating the representative function from the distribution function significantly reduces the compliance cost of future channel changes.
3. Run representative changes as a controlled process. Changing the representative means changing the contact channel to the regulatory authority: update the LoA and the responsible-party information on the labelling, and notify the DDF.

V. Verification checklist

• □ Confirmed that an overseas manufacturer can be named as licence holder and manufacturer on the certificate
• □ Confirmed that the submitting applicant is a locally licensed company
• □ The letter of authorisation states the licence holder, manufacturer and applicant identities separately
• □ Assessed the independent third-party authorised representative model
• □ Confirmed that the local entity employs a Cambodian registered pharmacist
• □ A controlled process for representative changes and DDF notification is in place

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).

Business enquiries: info@grzanglobal.com