自由销售证明与 ISO／GMP 证书：原产国证据怎么组织

1. Key takeaways

Cambodia requires country-of-origin evidence in risk-based tiers; the document list for Class A differs from that for Classes B/C/D:

The Certificate of Free Sale and the ISO/GMP certificates must be issued by the country of origin; as documents formed abroad, they will inevitably trigger the translation, notarisation and consular legalisation chain (see article 29).

GRZAN note: the Cambodian document list has 2 tiers — 4 items for Class A and 7 for Classes B/C/D; 3 items are required in both tiers (GMP/ISO certificate, Certificate of Free Sale, Letter of Authorization).

2. Legal basis

3. Expert insights

1. “Endorsed by an official body” is the substantive threshold for GMP/ISO certificates. The requirements state that the GMP or ISO certificate must be endorsed by an official body. The ISO 13485 certificate submitted should therefore come from an accredited certification body, and the certificate’s scope must cover the manufacturing site and product range of the product under application. Multi-site manufacturers should provide quality system evidence for each relevant site separately.

1. A Certificate of Free Sale proves “lawfully marketed in the country of origin”, not “registered in the country of origin”. The two are not equivalent in many markets — some issue free sale certificates, others marketing authorisation certificates. Cambodia’s wording is “documents evidencing that the product has been marketed in the country of origin”. In practice, an export sales certificate issued by the competent authority of the country of origin — for China-origin products, the certificate issued by China’s NMPA — is a common way to satisfy this form; because issuing conditions and formats change, confirm the current version with the issuing authority before applying.

1. Class A may substitute “sample or catalogue” for technical documentation, but do not take the Class A dossier lightly. Although Class A does not mandate a full technical file, the GMP/ISO certificate, Certificate of Free Sale and Letter of Authorization are still required. More importantly, Cambodia does not permit product grouping; for a Class A product with many SKUs, preparing these three documents model by model is still a considerable workload.

4. Practical recommendations

1. Build a “certificate validity matrix”. List the validity periods of the ISO 13485 certificate, the Certificate of Free Sale, other countries’ registration certificates and the CoA in one table, with renewal reminders set 6 months ahead. A certificate expiring during review is one of the most common causes of stalled Cambodian projects.
2. Check the scope of the ISO certificate. Confirm that the site addresses and product scope on the certificate match the application; for multi-site or contract manufacturing, attach the subcontractor’s qualifications and a summary of the quality agreement.
3. Arrange the CoA early for Classes B/C/D. The Certificate of Analysis is issued by the manufacturing organisation and must correspond to the applied-for batch or a representative batch; it is likewise a foreign-formed document and must enter the translation and legalisation chain.

5. Verification checklist

• □ Applicable document list confirmed for Class A or Classes B/C/D
• □ GMP or ISO certificate from a recognised body and within its validity period
• □ Site and product scope on the ISO certificate match the application
• □ Certificate of Free Sale issued by the country of origin and evidencing marketing there
• □ Other countries’ registration certificates, CoA and technical documentation assembled for Classes B/C/D
• □ Validity periods of all foreign-issued certificates covered by the 6-month renewal reminder mechanism

Regulatory information verified as of 29 October 2026.

In Southeast Asian markets, GRZAN’s core capabilities concentrate on three points. First, distinguishing 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, whereas Cambodia still has no dedicated Medical Device Law; the current rules are assembled from three layers: the registration-number legal basis provided by the 1996 Law on Drug Management 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. Compliance certainty is therefore markedly 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 submission, regulatory communication and post-market reporting obligations, and assisting with the practical requirements for a Cambodian registered pharmacist and a drug import-export enterprise licence. Third, quality system and testing support: helping establish a quality management system that meets ISO 13485 requirements and organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

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