授权书（LoA）与符合性声明（DoC）的写法与常见退件点

1. Key takeaways

The Letter of Authorization (LoA) and the Declaration of Conformity (DoC) are the two most central documents in the administrative dossier for device registration in Cambodia, and both are mandatory items on the Class A and Classes B/C/D lists.

• The LoA addresses “who may file”: issued by the overseas manufacturer or product owner, it authorises a licensed local Cambodian company to act as applicant, to file with DDF, to communicate and to receive the registration certificate on its behalf;
• The DoC addresses “what the product conforms to”: the manufacturer declares that its device meets the essential requirements of Prakas No. 1258 and the AMDD (the Essential Principles of Safety and Performance).

Both documents are legal instruments formed abroad and must enter the translation, notarisation and consular legalisation chain.

GRZAN note: the LoA and DoC are mandatory items on the document lists of all 4 classes; they are the only 2 legal documents that run from Class A to Class D. Their issuers differ — the LoA is issued by the product owner, the DoC by the manufacturer.

2. Legal basis

3. Expert insights

1. The LoA’s scope of authorisation must match Cambodia’s “filer/holder separation” structure. Cambodia allows the overseas manufacturer to be named as registration holder on the certificate, but the filer must be a licensed local company. The LoA should therefore deal with the two separately: authorise the local company to file and communicate, while keeping the overseas manufacturer named on the certificate as holder and manufacturer. An LoA that says only “authorises its agent” without distinguishing filing rights from holding rights creates ownership disputes when the importer changes.

1. The DoC must state that the object of conformity is the essential requirements of Prakas No. 1258 and the AMDD. Cambodia’s technical review rests on Prakas 1258 and the CSDT; a DoC that only broadly declares “conformity with ISO 13485” or “conformity with EU requirements” without pointing to the Cambodian instruments and the ASEAN essential requirements will be treated as citing the wrong benchmark.

1. The validity periods and model coverage of both documents are high-frequency rejection points. Cambodia does not permit product grouping, and different models must be registered separately. An LoA or DoC that covers only one lead model without listing all SKUs, or whose validity is shorter than the expected review period (12 to 18 months), will lapse mid-review.

4. Practical recommendations

1. Draft the LoA with “filing rights + holding rights” stated separately. State in the document that the local company is authorised as applicant to file and to receive official correspondence and the registration certificate; record the overseas manufacturer’s status as holder and manufacturer on the certificate; and set out termination conditions and dossier handover arrangements.
2. Map the DoC item by item against the essential requirements list. The DoC should correspond line by line with CSDT Module B (the Essential Principles checklist), state the method adopted for each principle (standards, recognised technical approaches, comparison with comparable devices already on the market, among other methods), and give the specific document references for each item.
3. Set validity above the expected review period. Given the mainstream practitioner timeline of 12 to 18 calendar months with possible carry-over, set the validity of the LoA and DoC at no less than 24 months, or use wording such as “valid until the date of issuance of the registration certificate”.

5. Verification checklist

• □ LoA issued by the product owner, with filing rights and holding rights distinguished
• □ LoA scope covers all models under application (no grouping assumed)
• □ DoC issued by the manufacturer and pointing to Prakas No. 1258 and the AMDD essential requirements
• □ DoC mapped line by line to the CSDT Module B checklist
• □ Validity periods of both documents set above the expected review period
• □ Both documents through translation, notarisation and consular legalisation

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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