Hong Kong Updates MDACS Guidance on Certificates, Conditional Approval and Inspections

Hong Kong's Medical Device Division (MDD) updated five Guidance Notes and five Codes of Practice under the Medical Device Administrative Control System (MDACS), effective 1 September 2026. The notice covers GN-01, GN-04, GN-07, GN-08 and GN-09, together with COP-01 to COP-05. Listing applications already submitted through the Medical Device Information System (MDIS) are unaffected and need not be resubmitted.

The package concerns device listing applicants, Local Responsible Persons (LRPs), conformity assessment bodies (CABs), importers, local manufacturers and distributors. These are final administrative guidance documents within the voluntary MDACS; they are not new legislation or statutory product registration. The September notice covers different documents from the July GN-02/GN-06 update and GN-10 revision.

Conditional approvals and certificate checks

GN-01, clause 5.10, expressly describes rejection, approval and conditional approval of device listing applications. Any special conditions are stated in the approval letter; failure to comply can lead to delisting. Corresponding provisions appear in GN-04, clause 6.6, for CABs, GN-07 clause 7.5 for importers, GN-08 clause 5.7 for local manufacturers, and GN-09 clause 4.9 for distributors. An applicant should read the actual conditions of its grant rather than assume every approval will carry them.

GN-01 clauses 5.6.2–5.6.3 add certificate-validity and verification provisions, mirrored in the other four updated Guidance Notes:

• Certificates must be valid when the application is submitted. If one expires during assessment, a renewed, valid certificate must be supplied on request.
• An electronic certificate is sufficient when it carries a valid, verifiable electronic signature of an authorized person and its authenticity can be checked through the issuer's designated official website.
• Other electronic documents have a separate condition: a verifiable authorized signature under the issuing company's domain, with a timestamp.
• Where authenticity or accuracy is in question, MDD may request a certified copy, check the certifier's qualifications, or verify directly with the issuer.

The provisions therefore support electronic submissions subject to verification. They do not guarantee acceptance of an unverifiable scan or eliminate MDD's ability to request supporting evidence.

Local manufacturers: inspections, validity and a conflicting clause

GN-08, clause 4.10, requires cooperation with MDD inspections on request during an application or after approval. This includes supplying records and documented procedures and permitting inspection of business premises and related storage or transportation facilities.

Clause 5.6.1 states that manufacturer listings last five years unless the Local Manufacturer Listing Approval Board decides otherwise. Clause 5.8.1 requires renewal submissions between 12 weeks and one year before expiry, inclusive; applications outside that window are not accepted. An expired listing requires a new application. The revision history identifies the validity clause as a September addition, but records an earlier renewal clause in December 2025: the whole renewal mechanism should not be described as newly introduced this September.

There is an unresolved inconsistency in COP-03, clause 2.12.1. It addresses a listed local manufacturer but refers to a three-year period and the List of Distributors. This conflicts with GN-08's manufacturer-specific five-year wording. Pure Global's comparison suggests a drafting inconsistency; the reviewed notice does not establish which text takes precedence or provide a correction. Manufacturers should confirm their listing expiry and renewal treatment with MDD, citing both clauses.

Importers, distributors and Codes of Practice

GN-07, clauses 4.1.2–4.1.3, lists a Hong Kong business registration certificate and either the specified documented procedures or an ISO 13485/ISO 9001 certificate covering those procedures together with the quality manual. Clause 5.1.2 requires supply-record retention for at least the projected device service life or seven years from supply, whichever is longer.

GN-07 clause 8.1 and GN-09, clause 6.1, specify three-year importer and distributor listings, subject to their stated approval qualifications. Their renewal provisions use the same 12-week-to-one-year submission window. COP-04, clause 2.5, and COP-05, clause 2.6, address those renewals.

COP-01, clauses 3.14–3.15, addresses the LRP's renewal of a device listing, with five-year validity and the same submission window. It is not a five-year registration of the LRP itself. COP-02, section 4, adds the MDIS application route for CAB recognition-scope changes. The package also adds express provisions on compliance with the existing Prevention of Bribery Ordinance; it does not create a new anti-bribery law.

Practical review for listing teams

Pure Global's analysis is that teams should make three targeted checks: map certificate expiry and verification methods to the submission timetable; assign responsibility for any conditions in approval letters and inspection requests; and calendar renewals using the relevant listing type and actual approval expiry. Local manufacturers should resolve the GN-08/COP-03 discrepancy before relying on an assumed expiry date.

For the wider listing framework, see our Hong Kong medical device market page.