Out of Scope: Class I GMD and Class A IVDMD Under MDACS

1. Key takeaways

The listing scope of MDACS covers Class II, III and IV general medical devices (GMD) and Class B, C and D in vitro diagnostic medical devices (IVDMD). Class I GMD and Class A IVDMD sit at the lowest risk level and are outside the listing scope: no listing application can be submitted and no listing number exists. Some products that still meet the medical device definition are also excluded from the current MDACS scope, and the list appears at paragraph 3.2.1 of GN-01. The exclusion is not a waiver but a boundary of scheme design: low-risk devices do not consume administrative capacity and are instead constrained indirectly by other ordinances and by procurement rules.

For a manufacturer the consequence is asymmetric. A product correctly classified at Class I needs no listing and cannot obtain one, so any tender requirement framed around a listing number has to be answered by other evidence. A product wrongly placed at Class I loses both the listing route and the tender route at once, and there is no appeal against a classification that was never submitted.

The GRZAN view. The cheapest correction is the one made before the dossier is written, because a classification error discovered after submission costs both the fee-free window and the procurement calendar.

2. Legal basis

Scope is defined by two documents. GN-01, current version updated and issued on 1 September 2026, states at paragraph 3.2.1 which products fall outside the existing MDACS scope despite meeting the definition. Classification itself is governed by technical reference documents: TR-003 for general medical devices, with rules derived from the GHTF harmonisation documents, and TR-006 for in vitro diagnostic medical devices. The MDD overview uploaded on 8 October 2025 restates the coverage and the device categories, and GN-00 supplies the definitions and abbreviations used across the scheme, in a Chinese version updated on 2 October 2025.

Two official classification tools exist. MDD publishes a general medical device classification programme and an in vitro diagnostic medical device classification programme. Their output is the practical basis for a written determination, and it should be retained with the date and the tool version recorded.

3. Expert insights

Risk classification is a scope switch, not merely a difficulty switch. Under the NMPA system in the Chinese mainland, a Class I device still requires filing. Under MDACS in Hong Kong, China, a Class I GMD and a Class A IVDMD do not enter the application channel at all. That difference is often read as Hong Kong, China taking a lighter view of low-risk devices. The better reading is resource allocation: assessment capacity is concentrated on devices at Class II and above, and the low-risk tier is left to general product safety law.

No listing does not mean no constraint. A low-risk device supplied in the territory must still satisfy other ordinances. Consumer goods for private use fall under the Consumer Goods Safety Ordinance (Cap. 456), and promotional statements fall under the Trade Descriptions Ordinance (Cap. 362). At the same time, the Phase C procurement rules define applicable medical devices as covering only Class II, III and IV GMD and Class B, C and D IVDMD, so low-risk devices are outside the procurement requirement for listing as well. The compliance file for such a product is therefore a product safety file, not a registration file.

Misclassification is the most expensive error in the set. Treating a Class II product as Class I means no application can be filed and tender eligibility is lost outright. Treating a Class I product as Class II means paying for documentation that no authority needs and adding months to a launch that required none. The two errors point in opposite directions but share a cause: classifying by analogy to a similar product instead of by applying the rules.

The exclusions in paragraph 3.2.1 deserve a separate check. A product can be a medical device in the ordinary sense and still be outside the scheme. Where that is the case, no amount of dossier quality changes the outcome, and the correct move is to document the exclusion and switch to the ordinances that do apply.

4. Practical recommendations

• Classify before committing budget. Run the official online classification programme at project initiation, keep the written output, and record the determination date and tool version alongside it.
• Check paragraph 3.2.1 for borderline products. Where a product meets the definition but may be excluded, test it against the exclusion list first, so that a submission is not returned after preparation.
• Use an alternative evidence route for low-risk products. Where listing is unavailable, support the tender file with a screenshot of the official public list and the classification record, together with compliance evidence under Cap. 456 and Cap. 362.
• Reassess after any change of intended use. A change in intended purpose, technical characteristics or target population can move the product into the listing scope, and the earlier determination then becomes misleading rather than protective.
• Keep the determination with the product record. The classification note belongs in the technical file, not in a personal folder, because it will be asked for by purchasers and distributors.

5. Verification checklist

• □ Attribute determination completed and the product confirmed as a medical device.
• □ Classification completed with the official online programme and written output retained.
• □ Product tested against the exclusion list at paragraph 3.2.1 of GN-01.
• □ Where Class I or Class A applies, alternative compliance evidence under Cap. 456 and Cap. 362 prepared.
• □ Definition of applicable medical device in the relevant procurement document confirmed.
• □ Classification record archived with the verification date noted.

Regulatory information verified as at 29 October 2026 against the official sources listed under legal basis; where those sources are updated, the latest published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team manages Medical Device Administrative Control System (MDACS) listings, coordinates import licensing, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com