注册与许可两道门：AMDD 第 1 条第 2、3 款与第 7 条

1. Key Takeaway

The AMDD designs market entry for devices as two gates, not one:

• Gate 1 — Registration: under Article 1(2) of the AMDD, the product owner or the authorised representative placing a device on the market of a member state must register the device with that country’s regulatory authority;
• Gate 2 — Licence (Placement Licence): under Article 1(3) and Article 7 of the AMDD, before placing the device on the market, the same parties must also obtain a licence.

In Cambodia, these two gates map to domestic law as the product registration number (Article 8 (new), paragraph 2 of the 2007 amendment) and the entity and activity licences (Article 8 of the 1996 Law and Article 8 (new), paragraph 1 of the amendment, covering business establishment, import and export operations, import and storage, and advertising).

GRZAN note: the AMDD designs 2 gates, set out in Article 1, paragraph 2 and Article 1, paragraph 3 together with Article 7; when mapped to Cambodian domestic law, the registration number rests on Article 8 (new), paragraph 2 of the 2007 amendment.

2. Regulatory Basis

3. Expert Commentary

1. “Registered, therefore sellable” is a widespread but wrong assumption. The structure of the AMDD treats registration and licensing separately, showing that they are parallel conditions, not a hierarchy. In Cambodia, after the product obtains its registration number, the entity must also hold the pharmaceutical import and export enterprise licence, and each consignment needs an import licence before entry. Merging these three into one mental item is a common cause of scheduling gaps.

1. The licensing duty attaches to the act of “placing on the market”, and the duty-holder is the product owner or the authorised representative. This means the duty does not shift by delegating the import to a third party: even where the actual import is performed by another licensed importing company, the pre-placement licensing duty remains with the product owner or its authorised representative.

1. Cambodia’s “pharmaceutical-style” licensing design adds extra activity licences. Article 8 of the 1996 Law and Article 8 (new), paragraph 1 of the amendment list four matters requiring authorisation: business opening, closing or relocation; import and export operations; import and storage; and advertising. Device companies therefore have to handle advertising approval separately, on top of product registration — a stand-alone pre-approval that does not exist in most device markets.

4. Practical Recommendations

1. Run “two gates plus one per-consignment action” as three separate cards. Card 1: product registration number (validity and renewal); Card 2: entity licences (company registration certificate + pharmaceutical import and export enterprise licence + registered pharmacist); Card 3: per-consignment import licence (before each shipment). Assign an owner and an expiry reminder to each card.
2. Schedule advertising planning early. Because advertising requires a DDF advertising licence obtained in advance, and the content must not exceed what the registration certificate states, finalisation of promotional material must precede the product’s arrival at port; otherwise there is a window in which “the goods have arrived but cannot be promoted”.
3. Name the duty-holder for placement in the contract. The agreement between the overseas manufacturer and the local importer should state who bears the pre-placement licensing duty, so that the obligation does not hang in the air.

5. Verification Checklist

• □ Product registration (AMDD Article 1(2)) distinguished from pre-placement licensing (Article 1(3) and Article 7)
• □ Confirmed the legal source of Cambodia’s registration number is Article 8 (new), paragraph 2 of the amendment
• □ Three separate management cards in place: product registration number, entity licences, per-consignment import licence
• □ Confirmed the entity holds the company registration certificate and the pharmaceutical import and export enterprise licence
• □ Promotional material finalised under both constraints: prior approval and no content beyond the registration scope
• □ The party bearing the pre-placement licensing duty named in the agreement

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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