药品进出口企业许可证与注册药剂师：绕不开的两项门槛

I. Key takeaways

To distribute medical devices in Cambodia, the entity must hold all three of the following:

1. Certificate of Incorporation (Certificate of Incorporation / Certificate of Corporate) — issued by the Ministry of Commerce (MoC);
2. Import-Export Pharmaceutical Company Licence — issued by the Ministry of Health (MoH);
3. A Cambodian registered pharmacist — must be of Cambodian nationality, hold a pharmacy diploma recognised by the MoH, have no criminal record, be in good health, and be a member of the Pharmacy Council of Cambodia; under Article 4 (new) of the 2007 Amendment Law, technical manufacturing, storage, distribution and wholesale must be handled and borne by this pharmacist.

In addition, opening, closing or relocating the business, and changing ownership or technical staff, all require prior approval from the MoH.

GRZAN note: the distribution entity must meet 3 conditions (2 licences + 1 pharmacist); the pharmacist must simultaneously meet 5 qualifications; business changes require the MoH’s prior approval.

II. Legal basis

III. Expert commentary

1. “Prior approval for changes in technical staff” is a continuing obligation that is easy to overlook. Companies focus on licensing at set-up but later neglect the approval requirement when replacing the pharmacist. The Amendment Law lists opening, closing, relocation, change of ownership and change of technical staff all as matters requiring approval, which means the pharmacist’s departure is itself a regulatory event, not merely an HR event.

1. The pharmacist’s responsibility covers “storage and distribution” — the core operations of a device company. Article 4 (new) of the Amendment Law states that technical manufacturing, storage, distribution and wholesale must be handled by the pharmacist. For a device company, warehousing conditions (Cambodia is hot and humid) and distribution records (the basis of post-market traceability) are both the pharmacist’s responsibility; the practical weight of this role exceeds what most companies expect.

1. The “pharmacist on site at every pharmacy” rule extends to wholesale and import-export operations. Article 8 (new) 4 of the Amendment Law extends the on-site requirement from pharmacies to manufacturing enterprises, import-export companies and wholesale companies. Together with the distribution restrictions discussed in article 35 (only licensed pharmacies may sell to end users), this forms a complete “person-premises-channel” control system.

IV. Practical recommendations

1. Make the pharmacist’s qualifications an annual review item. Each year verify the validity of the Pharmacy Council of Cambodia membership and the on-site status, and obtain MoH approval for the substitute before the pharmacist departs.
2. Bring warehousing and distribution records into the pharmacist’s signature scope. Make temperature and humidity logs, goods-in/goods-out records and batch traceability records pharmacist-signed documents; this satisfies the regulatory requirement and provides evidence for post-market traceability.
3. Start the approval process early for relocation and equity changes. Both require prior MoH approval; build them into the transaction timetable, as they cannot be regularised afterwards.

V. Verification checklist

• □ Certificate of Incorporation (MoC) obtained and within its validity period
• □ Import-Export Pharmaceutical Company Licence (MoH) obtained and within its validity period
• □ The registered pharmacist is a Pharmacy Council of Cambodia member in good standing
• □ On-site arrangement for the pharmacist and absence substitution plan in place
• □ Relocation, ownership change and technical staff change included in the prior approval process
• □ Warehousing and distribution records covered by pharmacist sign-off

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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