多用途器械如何定级：AMDD 第 4 条第 4 款的判定顺序

1. Key Takeaway

When a device falls into two or more classes simultaneously, Article 4(4) of the AMDD provides the test: classify according to the most critical intended use. The basis is the intended purpose stated by the manufacturer in the product instructions and the functional capability of the device — not the age of the model and not the sales pitch.

In practice, this means that for combination-function devices, platform devices and devices with software modules, the class is determined by the single most critical use, not by the use with the highest sales volume or the latest model.

GRZAN note: classification of multi-purpose devices follows Article 4(4) of the AMDD, resting on 1 criterion — the most critical intended use; the intended purposes needed for classification come from 2 sources — the manufacturer’s instructions and the functional capability of the device; there are 4 classes in total.

2. Regulatory Basis

3. Expert Commentary

1. “Most critical” is a risk-based expression, not a commercial one. It points to the use whose failure would cause the most severe consequences, not the use that generates the most revenue. A device with both physiotherapy massage and electro-stimulation therapy functions is classified by the electro-stimulation use if that use carries the higher risk — even if massage drives most of the sales.

1. The intended purpose is stated by the manufacturer, which makes it a controllable variable. Article 4(4) rests the test on “the data provided by the product owner in the instructions for use” and “the functional capability of the device”. The former is something the manufacturer can actively manage: if the company defines the intended purpose narrowly for the Cambodian market and keeps it consistent across instructions, labelling and promotional material, the classification has a clear basis. Conversely, broad instructions contradicted by the promotional claims give the reviewer grounds to classify at a higher class.

1. The classification conclusion is the upstream variable for everything that follows. It determines not only labelling but how deep the dossier must go, how the licence route runs and how long it takes. The cost of a misclassification rarely appears on submission day; it accrues line by line through deficiency responses, explanations and supplementary verification data.

4. Practical Recommendations

1. Freeze the intended-purpose wording before preparing the technical documentation. Unify the intended-purpose statements across the Cambodian-market versions of the instructions, labelling and promotional material into one passage, signed off by regulatory, marketing and sales. This passage becomes the common baseline for classification, for the depth of clinical evidence and for labelling review.
2. Build a “use list plus risk assessment” cross-table for combination-function products. List each use, the associated risk and the possible class, take the highest class of the most critical item, and record the derivation in the dossier.
3. Reserve documentation headroom for a one-class upgrade. Because the DDF has the power to reclassify and Cambodia has no internal appeal buffer, preparing clinical evidence and technical data to the highest plausible class is more economical than supplementary submissions later.

5. Verification Checklist

• □ All intended purposes of the product listed and risk assessed item by item
• □ Class determined by the most critical use under AMDD Article 4(4)
• □ Intended-purpose wording used for classification unified across instructions, labelling and promotional material
• □ Classification derivation recorded in the technical dossier
• □ Clinical evidence and verification data reserved at the highest plausible class
• □ Classification conclusion confirmed consistent with the annex selection in article 07

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities concentrate on three areas. First, distinguishing the legislative progress of dedicated medical device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established a written device regulatory framework, whereas Cambodia still has no dedicated Medical Device Law; its current rules are assembled from three layers — the registration-number legal basis 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 provided by the ASEAN Medical Device Directive — leaving regulatory certainty materially 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 submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist requirement and the pharmaceutical import and export enterprise licence. Third, quality system and testing support: helping establish a quality management system meeting ISO 13485 requirements and organising the technical dossier according to the ASEAN Common Submission Dossier Template (CSDT).

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