基本安全与性能原则清单：逐条判定与检查表

1. Key takeaways

CSDT Module B requires the applicant to identify the Essential Principles of Safety and Performance applicable to the device, to describe the methods used to demonstrate conformity with each applicable principle, and to record conformity in the form of a checklist.

The Essential Principles consist of two parts:

1. general safety and performance requirements applicable to all medical devices;
2. safety and performance requirements on design and manufacturing, some of which are relevant only to specific devices.

The applicant’s obligation is to determine the applicable essential requirements itself and demonstrate conformity with each applicable one. Methods that may be used to demonstrate conformity include conformity with recognised or other standards, adoption of the state of the art or of in-house industry methods, and comparison with comparable devices already on the market.

GRZAN note: the Essential Principles have 2 parts; there are 3 classes of demonstration method (standards, state of the art or industry methods, comparison with comparable devices); the deliverable is 1 checklist.

2. Legal basis

3. Expert insights

1. “Applicability” is judged by the applicant, not announced line by line by the regulator. The CSDT text states expressly that “the manufacturer needs to determine the applicable essential requirements”. “Not applicable” is therefore also a conclusion that requires a stated reason; it cannot be left blank. Blank entries in the checklist are read during review as omissions, not as non-applicability.

1. The choice of demonstration method directly affects the likelihood of deficiency requests. The three method classes are not equally accepted in Cambodia: citing recognised international standards (the IEC 60601 series, the ISO 10993 series, ISO 11135/11137, for example) offers the strongest traceability; “state of the art or in-house industry methods” requires a methodological explanation; “comparison with comparable devices already on the market” requires marketing evidence for the comparator device and an equivalence argument. Prefer the standards route line by line.

1. The checklist supports the DoC; the two must correspond. The DoC declares “conformity with the essential requirements”; the checklist shows “how conformity is achieved”. A broadly worded DoC over a checklist covering only some principles creates a gap between the two documents — a common deficiency ground in Cambodian review.

4. Practical recommendations

1. Build the checklist with four columns: principle item / applicable or not / reason if not applicable / document reference for conformity evidence. The fourth column must point to specific documents in the dossier (standard certificates, test reports, validation records); writing the word “compliant” alone is not enough.
2. Give a technical reason for each non-applicable principle. For example: “this device contains no software, so the software life-cycle principles do not apply” — one sentence, but it must be there.
3. Send the checklist out for signature together with the DoC. Have both documents reviewed and signed by the same responsible person, ensuring consistent coverage.

5. Verification checklist

• □ All essential principles applicable to the device identified (general + design and manufacturing)
• □ Checklist in four-column format (item / applicability / reason / evidence reference)
• □ Technical reasons given for every non-applicable principle; no blank entries
• □ Conformity evidence document designated and locatable in the dossier for every applicable principle
• □ Recognised international standards preferred as the demonstration method
• □ Coverage of the checklist reconciled with the DoC

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).

Business enquiries: info@grzanglobal.com