MDACS and NMPA: Reference Approvals, Dual Track and Greater Bay Area Access

1. Key takeaways

An NMPA registration certificate from the Chinese mainland cannot replace an MDACS listing in Hong Kong, China, but it can be used in a listing application as a marketing approval from a reference jurisdiction. MDD recognises 8 such jurisdictions: the Chinese mainland (National Medical Products Administration), the United States (Food and Drug Administration), the European Union (member states that have implemented the relevant Council directives or regulations), Canada (Health Canada), Japan (Ministry of Health, Labour and Welfare), Australia (Therapeutic Goods Administration), Korea (Ministry of Food and Drug Safety) and Singapore (Health Sciences Authority). The practical optimum is a dual track: mainland registration for domestic sale and a Hong Kong, China listing for local procurement and re-export credibility, with one set of underlying technical documentation serving both.

The dual track is cheaper than it sounds, because the expensive part of either filing is the technical file, and that file is largely the same. What differs is the wrapper: the mainland submission argues against the classification catalogue and technical requirements, while the Hong Kong, China submission argues against MDACS classification rules and the evidence categories in GN-02 or GN-06.

The GRZAN view. The mistake to avoid is assuming that one approval travels with the product. Evidence travels; jurisdiction does not.

2. Legal basis

Reference approvals and the expedited scheme. GN-02 sets out the documents required for Class II, III and IV general medical devices and lists the reference jurisdiction approvals at item D002. GN-06 does the same for Class B, C and D in vitro diagnostic devices. The notes to the expedited listing scheme, reference ExpSch-Notes, list the recognised regulatory authorities at paragraph 3 and define an independent approval at paragraph 4. The MDD overview uploaded on 8 October 2025 describes the second route, built on a reference approval, as distinct from the conformity assessment body route. The Greater Bay Area work plan on regulatory innovation and development of medicinal products and medical devices, published by the NMPA in November 2020, provides the basis for the Hong Kong and Macao medicine and device connect arrangement.

Independence is a defined term. Paragraph 4 of the expedited scheme notes requires that an approval not depend on another approval, that is, it must not be one granted by reliance on a different approval, and that it carry an appropriate risk classification. For the European Union, the approval must come from a member state that has implemented the relevant Council directives or regulations.

3. Expert insights

Evidence may be borrowed; jurisdiction is not mutual. Hong Kong, China and the Chinese mainland are two separate customs territories with two regulatory systems. An NMPA certificate has no legal effect in Hong Kong, China, and an MDACS listing number creates no market access on the mainland. The common misunderstanding, that an NMPA certificate permits sale in Hong Kong, China, has no legal basis: there is no automatic extension of that kind in either direction.

Reference approvals must be independent and class-matched. The expedited scheme notes impose both conditions. An approval granted in reliance on another approval does not qualify, which excludes a number of fast-track approvals that were themselves built on a prior authorisation. The approval must also carry a risk classification appropriate to the product. A product listed at a different class abroad may therefore require an explanation, and in some cases the file has to rely on the conformity assessment body route instead.

One mainland approval can unlock two accelerated routes. Where a product already holds approval in the Chinese mainland and in another recognised jurisdiction, it satisfies the expedited scheme threshold of 2 or more valid approvals from independent regulatory authorities. This is a relative advantage that mainland manufacturers hold and European or American manufacturers do not, and it is often overlooked because the second approval is treated as a marketing asset rather than a regulatory one.

The Greater Bay Area offers a third route. The Hong Kong and Macao medicine and device connect arrangement allows designated medical institutions in the Greater Bay Area to use medical devices that are in clinically urgent demand and already procured and used by public hospitals in Hong Kong, China. As at 30 September 2026, 100 medical devices had been approved for use in 71 designated institutions. The direction of travel is the reverse of listing, from Hong Kong, China use to mainland designated use, but it draws on the same body of local use evidence.

4. Practical recommendations

• Share the underlying documentation. A mainland registration technical file, restructured rather than rewritten, can support a Hong Kong, China listing and remove the need for two parallel drafting exercises.
• Secure two independent approvals early. Treat the NMPA approval as the first and pursue a second from the US FDA, the European Union or Japan, which is the point at which expedited scheme eligibility can be assessed.
• Watch the class match. Where the Hong Kong, China classification differs from the mainland catalogue conclusion, follow TR-003 or TR-006 and explain the difference in the file rather than leaving the reviewer to find it.
• Do not equate re-export with access. A Hong Kong, China listing does not constitute mainland market access, and goods re-exported to the mainland still require mainland procedures.
• Assess the connect route on its own terms. The Greater Bay Area arrangement serves clinically urgent use in designated institutions and should be evaluated as a separate access channel, not as a substitute for listing.

5. Verification checklist

• □ NMPA registration certificate confirmed as valid and covering the models being filed.
• □ Existence of a second independent approval in a recognised jurisdiction confirmed.
• □ Approval documents confirmed to carry a risk classification consistent with the Hong Kong, China determination.
• □ Approval documents confirmed as not dependent on another approval.
• □ Independent Hong Kong, China classification completed, without direct reuse of the mainland catalogue.
• □ Applicability of the Hong Kong and Macao medicine and device connect route assessed.

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