The Eight Recognised Reference Jurisdictions and the Independence Test for MDACS Listing

1. Key takeaways

The Medical Device Division (MDD) recognises 8 reference jurisdictions under the Medical Device Administrative Control System (MDACS): the Chinese mainland (National Medical Products Administration), the United States (Food and Drug Administration), the European Union (member states that have implemented the Council directives or regulations on medical devices), Canada (Health Canada), Japan (Ministry of Health, Labour and Welfare), Singapore (Health Sciences Authority), Korea (Ministry of Food and Drug Safety) and Australia (Therapeutic Goods Administration). The decisive point is not that an approval exists, but that the approval is valid, independent and class-matched, with all three tests satisfied at the same time.

• The reference jurisdiction list is closed and finite: an approval from a regulator outside the 8 cannot open Route two, however stringent that regulator may be.
• Validity is measured at the submission date and has to be projected across the review period, not merely confirmed on the day the dossier is signed.
• Independence is a separate test from validity: an approval that stands only because another approval remains in force may fail it.
• Class matching is checked against the Hong Kong, China classification, so an approval that carries no class, or a lower class, needs supporting explanation.
• The list itself has been extended over time, which means the version consulted before each filing has to be the current one.

2. Legal basis

The list of recognised regulators and the definition of an independent approval both sit in the notes to the expedited approval scheme, while the documentary expectations for reference approvals are carried in the two listing guidances that apply by device type. The table below sets out the instruments and provisions used in this article.

The notes operate at the level of eligibility, while GN-02 and GN-06 set out what has to be placed in the dossier to demonstrate that eligibility. In practice the two layers are read together: the notes say which approvals count, and the guidances say how an applicant proves that a particular approval counts for a particular device.

3. Expert insights

First, independence is the requirement most often underestimated. Paragraph 4 of the notes defines an independent approval as one whose status does not depend on another marketing approval document. The typical risk scenario is an approval that depends for its validity on an EU CE certificate. A post-Brexit United Kingdom approval, or a Southeast Asian approval that relies on a reference country approval, may both be questioned on independence grounds. The applicant has to submit the whole set of marketing approval documents, including licences, certificates, approval letters and declarations, in order to demonstrate both validity and independence.

Second, the European Union wording refers to member states, not to EU institutions. The list uses the phrase member states that have implemented the Council directives or regulations on medical devices. That means an EU-based approval should be cited by naming the specific member state and the issuing body, rather than describing the product loosely as CE marked. A dossier that names only the marking invites a request for the underlying national approval, and that request consumes review time.

Third, the list expands, so the latest version governs. The Chinese mainland, Singapore and Korea were added as reference jurisdictions at a later stage than the original entries. Companies planning over a multi-year horizon should assume that the list will change again, and should re-check the version published on the MDD website before every submission rather than relying on a list captured in an earlier project file. A jurisdiction that was outside the list when a regulatory strategy was written may be inside it by the time the dossier is filed, and the reverse can also happen where wording is refined.

Fourth, class matching is the second filter. The notes require the approval document to carry an appropriate risk classification. Where an approval in a given jurisdiction does not state a class, or states a class lower than the one determined for Hong Kong, China, supplementary material explaining the classification has to be added (practical estimate). This is a documentary exercise rather than a new technical assessment, but it still has to be prepared in advance, because it is the point at which otherwise strong approvals are set aside.

4. Practical recommendations

• Build a three-check table for approval documents. Check whether the jurisdiction is among the 8, whether the approval is independent, and whether the classification matches. Only when all three pass should dossier preparation begin.
• Submit the whole set rather than a single page. File the licence, certificate, approval letter and declarations together, so that the evidence cannot be characterised as insufficient on its own terms.
• Name the member state for EU approvals. State the specific member state and the name of the issuing body in the dossier, and attach a link that allows the entry to be verified.
• Explain intra-group approvals specifically. Where approval documents are relied on within a corporate group, describe the legal basis for the approval and the source of its independence, rather than leaving the relationship implicit.

5. Verification checklist

• □ The issuing authority of the approval documents is on the list of 8 recognised jurisdictions
• □ The complete set of approval documents is ready (licence, certificate, approval letter, declarations)
• □ A written statement confirms that the approval does not depend on another approval document
• □ The approval documents carry an appropriate risk classification consistent with the Hong Kong, China determination
• □ EU-type approvals identify the specific member state and issuing body
• □ All approval documents are valid on the submission date

Regulatory information verified to 29 October 2026. The legislation, guidance and effective dates described in this article are limited to what the official sources listed under Legal basis had published on that date; where an official document has since been updated, the most recent 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 MDACS listing applications across all risk classes, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com