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Hong Kong MDACS Five Core Guidelines Updated and Effective on 1 September, Full-Chain Compliance Requirements Upgraded

Time：2026-09-03 11:09:51

On 1 September 2026, the Medical Device Division of the Department of Health, the Government of the Hong Kong Special Administrative Region, rolled out the 2026 edition of core guidelines under the Medical Device Administrative Control System (MDACS). The update covers five core documents: GN-01 Overview of the Medical Device Administrative Control System, GN-04 Conformity Assessment Framework and Conformity Assessment Bodies, GN-07 Medical Device Importer Listing Requirements, GN-08 Medical Device Local Manufacturer Listing Requirements and GN-09 Medical Device Distributor Listing Requirements, together with the accompanying Codes of Practice (COP-01 to COP-05), all officially effective on the same day.

This marks the most significant regulatory revision to Hong Kong’s MDACS framework this year, representing a further upgrade of the city’s medical device administrative regulation in digitalisation, full-chain compliance and anti-corruption risk control. It has direct implications for all medical device manufacturers, importers, distributors and certification bodies operating in the Hong Kong market.

一、Overall Overview of This Update

Hong Kong’s MDACS is the current pre-market administrative listing regime for medical devices in the city. Built on the framework of the International Medical Device Regulators Forum (IMDRF), it operates on a voluntary listing basis and acts as a transitional system ahead of the future mandatory medical device registration in Hong Kong.

This update delivers a comprehensive revision of the 2025 edition, covering five core modules: device listing, conformity assessment, importer management, local manufacturer management and distributor management, with corresponding Codes of Practice updated in parallel.

Important notice：Listing applications already submitted via the Medical Device Information System (MDIS) will not be affected by this update, and applicants are not required to resubmit any applications. Subsequent amendments, renewals and new applications shall follow the requirements of the updated guidelines.

二、Five Core Documents in This Update

GN-01:2026(C) Overview of the Medical Device Administrative Control System：The overarching framework of the entire MDACS regime, defining core requirements including system structure, classification rules, responsibilities of Local Responsible Persons (LRP) and device listing procedures.

GN-04:2026(C) Conformity Assessment Framework and Conformity Assessment Bodies：Specifies qualification accreditation, assessment procedures and supervision rules for Conformity Assessment Bodies (CABs), serving as the core basis for third-party bodies to participate in MDACS certification.

GN-07:2026(C) Guideline on Medical Device Importer Listing：Sets out detailed provisions on application criteria, procedural requirements, quality systems and record management for importer listing.

GN-08:2026(C) Guideline on Medical Device Local Manufacturer Listing：Regulates listing requirements for local medical device manufacturers in Hong Kong, focusing on the ISO 13485 quality management system and production process control.

GN-09:2026(C) Guideline on Medical Device Distributor Listing：Clarifies listing criteria, business premises requirements, traceability and recall management obligations for medical device distributors in Hong Kong.

三、Key Amendments and Interpretation

While retaining the overall MDACS framework, this revision upgrades requirements across four dimensions: anti-corruption compliance, digital adaptation, process transparency and enhanced traceability. The key changes are outlined below.

（一）Prevention of Bribery Ordinance

The most notable common change across all five guidelines is the addition of a dedicated chapter. It explicitly requires all applicants and relevant parties to strictly comply with the Prevention of Bribery Ordinance (Chapter 201 of Hong Kong) in all application procedures, communications and day-to-day regulatory interactions, and prohibits providing any improper benefits as defined by the Ordinance to any government officials.

（二）Unified Recognition Rules for Electronic Documents

All guidelines have refined the validity requirements for application materials:

Certificates submitted must be valid at the time of application; those expiring during the assessment period must be renewed promptly to avoid process disruption.
Electronic certificates issued by official regulatory authorities may be submitted directly if they contain valid and verifiable electronic signatures.
Electronic documents issued by enterprises must bear valid and verifiable electronic signatures of authorised personnel under the company’s domain, together with a timestamp.
The Department of Health reserves the right to request certified copies of questionable documents and to verify authenticity directly with the issuing authority.

（三）Comprehensive Refinement of Process Nodes

This revision has refined all process nodes including application acceptance, approval/rejection notification, appeal and information change:

Clarifies the acknowledgement mechanism for MDIS-submitted applications; applicants may follow up proactively if no acknowledgement is received within 2 weeks.
Refines scenarios for conditional approval and subsequent rectification requirements; failure to meet conditions may result in removal from the listing.
Unifies the appeal period to 14 working days from the date of receiving the decision, and clarifies the appeal process and the final binding effect of the appeal decision.
Sets out clearer time limits and evidentiary requirements for information change notification, to mitigate compliance risks caused by delayed updates.

（四）Aligned Requirements for Supply Chain Entities

Requirements for importers and distributors are further aligned with the manufacturer system:

Unified record retention period of at least 7 years or the expected service life of the device, whichever is longer.
Enhanced traceability requirements for high-risk devices, extending to the level of healthcare institutions and patients.
More detailed procedural requirements for product recall, medical incident reporting and complaint handling, clarifying the collaborative responsibilities of all parties.

四、Industry Compliance Recommendations

For different stakeholders, the following focus areas are recommended in response to this regulatory update:

（一）For enterprises with submitted listing applications

Resubmission is not required. However, if supplementary materials are requested during the subsequent assessment process, they shall be prepared in accordance with the updated guidelines.

（二）For manufacturers / Local Responsible Persons planning to apply for device listing

Sort out certification documents for products intended for listing in advance to ensure validity at the time of application.
Prioritise preparation of officially verifiable electronic certificates to improve assessment efficiency.
Conduct self-checks on labelling and instructions for use to confirm compliance with TR-004 and TR-005 labelling requirements.

（三）For importers and distributors

Conduct self-audits of internal SOPs against the updated guidelines, focusing on record management, warehousing and transportation, traceability and recall, and complaint handling modules.
Incorporate requirements of the Prevention of Bribery Ordinance into internal compliance systems and cooperation agreements with upstream suppliers and downstream customers.
For enterprises approaching listing expiry, plan renewal applications in advance (to be submitted between 12 weeks and 1 year before the expiry date).

（四）For local manufacturers

Ensure that the scope of ISO 13485 certification is consistent with the listed manufacturing scope.
Update the list of marketed products to the Department of Health on a regular basis, at least once a year.

（五）For Conformity Assessment Bodies (CABs)

Verify whether your qualifications meet the requirements of the Global Accreditation Cooperation Initiative (GACI) signatory accreditation bodies.
Improve internal processes to adapt to the supervision and witness assessment requirements of the Hong Kong Department of Health.

五、Conclusion

Since its implementation in 2004, Hong Kong’s MDACS has been continuously aligned with international mature regulatory systems. This revision is not only a systematic improvement of the regime itself, but also a signal that Hong Kong’s medical device regulation is gradually moving towards statutory and refined governance.For further enquiries, please contact Wiselink.

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