柬埔寨与泰国、马来西亚、越南的准入对比

1. Key takeaway

Among the six core ASEAN markets, Cambodia’s market access structure differs from Thailand, Malaysia and Vietnam in three essential respects:

(The Thailand, Malaysia and Vietnam columns are grade B/C secondary sources; verify each item against the official texts of the country concerned.)

GRZAN note: the three essential differences are 1 legislative gap (no dedicated law), 1 grouping prohibition (not permitted) and 1 timing mechanism (committee rounds every 3 to 4 months); Cambodia holds 0 regional recognition arrangements.

2. Regulatory basis

3. Expert commentary

1. Legislative form determines regulatory certainty. Thailand, Malaysia and Vietnam all have written device regulations that can be searched and checked directly; Cambodia does not, leaving companies dependent on the local entity and the DDF’s current interpretation. This turns Cambodia from a ”technical problem” into an ”information problem”.

1. “No product grouping” is a cost amplifier unique to Cambodia. Thailand, Malaysia and Vietnam all support family or group submissions in practice (Vietnam’s grouping rules are the most explicit); Cambodia does not. For the same product family, the workload in Cambodia can be several times that in Vietnam.

1. Regional recognition is reshaping ASEAN, but Cambodia is for now absent. Malaysia and Thailand moved their reliance scheme to full implementation on 1 May 2026; a recognition arrangement also exists between Singapore and Malaysia; Vietnam achieves de facto acceleration through a reference authority fast track (including China’s NMPA). Cambodia has not entered any such arrangement — which means that, as regional recognition keeps expanding, Cambodia’s relative cost of market access may rise rather than fall.

4. Practical recommendations

1. In ASEAN multi-country planning, treat Cambodia as a ”high-touch-cost” market. Neither budget nor timeline should be extrapolated from the Thai, Malaysian or Vietnamese experience.
2. Obtain a Malaysian or Thai registration certificate first, then use it as reference-market evidence to support the Cambodian submission. Although there is no recognition channel, reference-market evidence still carries real weight in Cambodian review.
3. For Vietnam, assess eligibility for the reference authority fast track. Vietnam lists China’s NMPA among its reference authorities, so manufacturers holding NMPA certificates may find a faster path in Vietnam than in Cambodia (grade B, to be verified separately).

5. Verification checklist

• □ Confirmed that Cambodia has no dedicated device law, in contrast to Thailand, Malaysia and Vietnam
• □ Cambodia’s SKU workload recalculated on the ”no product grouping” basis
• □ Confirmed that Cambodia is not part of the Malaysia–Singapore or Malaysia–Thailand recognition/reliance arrangements
• □ Cambodia’s timeline modelled separately in multi-country scheduling (including committee windows)
• □ Specific regulatory details for Thailand, Malaysia and Vietnam flagged for verification against each country’s official texts
• □ The ”obtain Malaysia/Thailand certificate first, then support the Cambodian submission” pathway assessed

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, whereas Cambodia still has no dedicated Medical Device Law. The current rules are assembled from three layers: the legal basis for registration numbers 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 of the ASEAN Medical Device Directive. Regulatory certainty is therefore markedly lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN may act as the manufacturer’s statutory representative in Cambodia, carrying registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist and pharmaceutical import/export enterprise licence requirements. Third, quality system and testing support: assisting with the establishment of a quality management system meeting ISO 13485 requirements, and organising the technical dossier in accordance with the ASEAN Common Submission Dossier Template (CSDT).

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