标签与使用说明书：语言、必备项与常见退件点

1. Key takeaways

Cambodia’s language requirements for labelling and for submission documents operate at two different levels:

• Labelling: medical devices must be labelled in Khmer or English;
• Submission documents (including the technical dossier): should be printed clearly in English, French or Khmer; documents in any other language must carry, in addition to the original, a complete certified or notarised translation, and the certification of the translation must be done at the Cambodian embassy or consulate nearest to the country where the document was produced; the applicant or marketing authorisation holder is responsible for the accuracy of the translation.

Under Prakas No. 1258, the mandatory label content includes at least: the product name, the name of the manufacturing organisation and the country of manufacture, the address and country of the party responsible for the product, the manufacturing date/batch number/expiry date, storage conditions, precautions and restrictions on use, and other necessary information. In addition, medical devices that differ in appearance or trade name and are produced by different manufacturers must be registered separately.

GRZAN note: label language is Khmer or English (a 2-way choice); submission document language is English, French or Khmer (a 3-way choice); mandatory label items number at least 6 categories.

2. Legal basis

3. Expert insights

1. Label language and document language are two distinct requirements; mixing them up causes errors on both fronts. Labels accept only Khmer or English; submission documents accept English, French or Khmer. Using French for the label because “documents may be in French”, or assuming that all documents may be supplied in English only because “labels may be in English”, will each trigger rejection.

1. The “party responsible for the product” is a mandatory label item, which directly constrains the local entity’s information disclosure. Prakas No. 1258 requires the label to state the address and country of the party responsible for the product. Because overseas manufacturers cannot file on their own and a licensed local company acts as applicant, the label will normally need to carry the local responsible party’s details. When the local representative changes, the label must be updated in step — the item most easily missed in change management.

1. AMDD Article 10 returns labelling specifics to the member states. Cambodia’s labelling rules therefore rest on domestic requirements, not on Annex 7. With Cambodia’s labelling rules not fully public, the prudent approach is to satisfy both the mandatory items listed in Prakas No. 1258 and the structure of Annex 7, taking the union of the two.

4. Practical recommendations

1. Submit label artwork with the dossier, identical word for word to the online entry and to the labelling section of the technical dossier. Any mismatch among the three is a high-frequency rejection point. Generate all three outputs from one master label file.
2. Prepare label artwork separately for every SKU. Cambodia does not permit product grouping; different models, specifications, appearances or trade names must be registered separately, so labels must also be prepared model by model — one generic artwork will not do.
3. Bring “responsible party” changes into the change management process. A change of local representative, address or contact details triggers a labelling update obligation, to be processed together with the registration certificate variation.

5. Verification checklist

• □ Labels in Khmer or English
• □ Labels contain all 6 categories of mandatory items (name, manufacturing organisation and country, responsible party’s address and country, date/batch number/expiry, storage conditions, precautions)
• □ Submission documents in English, French or Khmer
• □ Originals not in English/French/Khmer accompanied by notarised complete translations
• □ Label artwork prepared separately for every SKU
• □ Label artwork identical word for word to the online entry and to Module E of the technical dossier

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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