逐批进口许可：从注册证到清关的单据链条

I. Key takeaways

Only registered medical devices may be imported into Cambodia for sale. Holding a registration number does not mean goods can ship directly — Cambodia operates a per-shipment import licence system: after obtaining the registration certificate, an import licence for each consignment must be applied for from the competent authority before that consignment is imported.

The customs document chain typically includes the product registration certificate, the import licence for that consignment, the commercial invoice, the packing list and a certificate of origin, plus a quality certificate conforming to international standards. On arrival at the port, customs clearance is completed against the import licence and the other documents, with the applicable customs duty and VAT payable; duty rates are determined by the specific HS code.

GRZAN note: importation involves 2 procedures (product registration number + per-shipment import licence); customs documents run to at least 5 categories; as an ASEAN member, Cambodia also requires attention to alignment with ASEAN regional rules at import (practical interpretation).

II. Legal basis

III. Expert commentary

1. The “registration number” and the “import licence” are two independent procedures on entirely different rhythms. The registration number is obtained once and is valid for three years (see article 37); the import licence is processed per consignment. If supply chain scheduling assumes that holding the certificate is enough to ship, the first shipment will get stuck.

1. Consistency between documents is the practical risk point at clearance. If product descriptions or model numbers on the commercial invoice differ from the import licence, customs will require an amended declaration and demurrage charges follow. Because Cambodia does not allow product grouping and each model is registered separately, the model list is long in itself; item-by-item checking between invoice and licence should not be underestimated.

1. HS code classification affects both duty rates and release speed. Medical devices have specific HS codes in Cambodia; correct classification smooths clearance, while misclassification not only affects duty but may trigger goods inspection. Complete a pre-confirmation of the classification before the first shipment is despatched (practical interpretation).

IV. Practical recommendations

1. Build the per-shipment import licence into the pre-despatch standard operating procedure. In sales contracts or despatch notices, make “import licence obtained” a release precondition rather than something to fix after arrival.
2. Create a single-source mechanism linking model master data to document generation. Generate the registration certificate list, the import licence application, the commercial invoice and the packing list from the same model master data to avoid manual entry differences.
3. Complete HS code pre-confirmation and document pre-review ahead of the first shipment. Engage an experienced customs broker to pre-review the full document set; this materially reduces demurrage risk on the first shipment (practical interpretation).

V. Verification checklist

• □ Product registration certificate obtained and within its validity period
• □ Import licence for each consignment obtained before despatch
• □ Customs documents complete (registration certificate, import licence, invoice, packing list, certificate of origin)
• □ Product descriptions and model numbers match item by item between invoice and import licence
• □ HS code classification pre-confirmed
• □ Document pre-review completed for the first shipment

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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