Two MDACS Listing Pathways: CAB Certification Assessment or Reference Jurisdiction Approval

1. Key takeaways

Under the Medical Device Administrative Control System (MDACS) there are only two evidence routes to a listing. Route one is a certification assessment carried out by an accredited Conformity Assessment Body (CAB), together with the certificate that the CAB issues on completion. Route two is the submission of marketing approval documents issued in a recognised reference jurisdiction. The selection test fits into a single sentence: where a reference approval already exists, Route two applies; where it does not, Route one is the only option. The difference between the two is not one of difficulty but of the source of evidence. Route two is shorter and cheaper, on the condition that the applicant already holds an approval from one of the 8 recognised jurisdictions.

• Route one rests on a CAB certificate, so the CAB must be accredited and its scope must cover the category and class of the device being listed.
• Route two rests on an approval issued in one of the 8 recognised reference jurisdictions, and that approval has to be valid, independent and aligned in classification.
• Route two is faster and less costly, but it is open only to applicants who already hold such an approval at the moment of submission.
• Whichever route is used, the certificate or approval must stay valid through the review, because a lapse can interrupt the assessment rather than merely delay it.
• Switching from Route two to Route one after filing means obtaining a CAB certificate from the beginning, so eligibility should be settled before anything is submitted.

2. Legal basis

The two routes are not a matter of administrative preference. They are set out in the overview of the listing process published by the Medical Device Division (MDD), while the obligations that surround certificate validity and verification sit in the guidance documents governing applications. The table below records the instruments relied on in this article and the provisions that carry the operative rules.

GN-02 and GN-06 carry the dossier requirements that apply once a route has been chosen, and the two routes differ only in the evidence that opens the dossier, not in the substance of what the dossier must establish. That is why the choice of route belongs at the very start of a project: it determines which set of documents is assembled, which party signs them, and how long the assembly takes.

3. Expert insights

First, the CAB is a framework rather than a roster of bodies. The full title of GN-04 refers to the certification assessment framework and to the certification assessment bodies, which shows that MDD defines the framework before it accredits any body to operate within it. The list of accredited CABs is published openly on the MDD website under the conformity assessment bodies list. When a CAB is selected, its accreditation scope has to be checked against the category and class of the product being listed; a body that is accredited for a different device family cannot supply usable evidence for this application.

Second, the revision of 1 September 2026 turned certificate validity into a hard clause. Clauses 5.6.2 to 5.6.3 of GN-01 add rules on the validity period of a certificate and on its verification. The certificate has to be valid at the time the application is submitted, and if it expires while the assessment is running, an updated valid certificate has to be provided on request. Expiry is therefore no longer a minor housekeeping matter: it is an event that can interrupt the assessment, with the delay that interruption implies.

Third, electronic certificates are accepted on conditions. The same provisions make clear that an electronic certificate is sufficient where it carries a valid and verifiable electronic signature of an authorised officer and where its authenticity can be checked on the designated official website of the issuing body. Other electronic documents have to carry a verifiable authorised signature under the domain of the issuing company, together with a timestamp. The practical reading is that a scanned copy is not the same thing as valid evidence; verifiability is what counts, and it has to be demonstrated rather than assumed.

Fourth, a route can be switched, but the price is starting again. If a reference approval is found during a Route two assessment not to be acceptable, converting to Route one means obtaining a CAB certificate afresh, and that cycle is measured in months (practical estimate). The eligibility self-assessment therefore has to be completed before submission, not alongside it. A project that discovers its evidence problem only after filing has already spent the review window it was trying to save.

4. Practical recommendations

• Run an eligibility self-assessment before filing. Check each reference approval document in turn: whether it comes from one of the 8 recognised jurisdictions, whether it covers the models being declared, whether it carries an appropriate risk classification, whether it is within its validity period, and whether it is independent.
• Write a scope clause into the CAB contract. When a CAB is engaged, state in the contract that the assessment scope covers the product category and class, so that a scope mismatch cannot later render the certificate unusable.
• Put expiry dates into a single register. Record the expiry dates of CAB certificates, quality system certificates and reference approval documents in one register, and submit renewals proactively before any date falls during a review.
• Keep the verification path ready. Retain the official verification web address and a description of the verification method for each issuing body, so that MDD can check the documents without a round of correspondence.

5. Verification checklist

• □ Confirmed whether the product holds a marketing approval in any of the 8 recognised jurisdictions
• □ Confirmed that the approval documents cover the declared models and match the risk classification
• □ Confirmed that the approval documents are valid on the submission date, with validity projected across the review period
• □ If Route one is used, confirmed that the CAB accreditation scope covers this product
• □ Verification path or certified copy ready for any electronic certificate
• □ All certificate expiry dates recorded in the register

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