LCQ12: Medical device administrative control system
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Question:
The Medical Device Administrative Control System (MDACS) currently implemented by the Department of Health (DH) operates on a voluntary listing basis. The Government plans to introduce a legislative proposal on the statutory regulation of medical devices in due course. In this connection, will the Government inform this Council:
(1) of the respective numbers of General Medical Devices and In Vitro Diagnostic Medical Devices of each class listed under MDACS in each of the past three years; whether the Government has estimated the percentage of currently listed devices relative to all applicable medical devices in circulation in Hong Kong;
(2) whether DH will consider working with the Innovation, Technology and Industry Bureau (for example, through the Hong Kong Laboratory Accreditation Scheme administered by the Hong Kong Accreditation Service) to support the development of and accredit more local testing institutions and conformity assessment bodies, with a view to progressively establishing a "Hong Kong Medical Device Certification Centre" with international legal credibility and an independent brand; and whether, it will mandate the adoption of Unique Device Identification in the post-market surveillance system and link it with the Electronic Health System (eHealth) mobile applications and the Hospital Authority's clinical database, so as to establish a proactive, regional-level medical device safety surveillance centre; if so, of the details; if not, the reasons for that;
(3) as there are views suggesting that Hong Kong lacks interdisciplinary talents who are well-versed in the medical device regulatory science, biomedical engineering and compliance management under common law, whether the Government has assessed the gap between manpower supply and demand in the relevant sector over the next five years, and discussed with post-secondary institutions the introduction of relevant transdisciplinary programmes and/or the establishment of statutory certification of professional qualifications; and
(4) whether the Government will seize the opportunity of hosting the annual meeting of the Global Harmonization Working Party in Hong Kong in December this year to discuss with regulatory authorities of other jurisdictions the signing of mutual recognition agreements on medical device regulation, so that medical devices registered and certified in Hong Kong, together with their testing reports and related legal compliance services, may be directly exported to other markets; if so, of the specific work plan?
Reply:
President,
Since 2004, having made reference to the recommendation of the Global Harmonization Task Force (now known as the International Medical Device Regulators Forum), the Department of Health (DH) has implemented the voluntary Medical Device Administrative Control System (MDACS). The MDACS covers a listing system for local manufacturers, importers and wholesalers (collectively referred to as traders) and for medical devices, as well as a post-market monitoring system for medical devices.
The Chief Executive has, in the Policy Addresses from 2023 to 2026, successively put forward measures to develop Hong Kong into an international health and medical innovation hub. The measures include enhancing the current approval and registration mechanism for drugs and establishing an internationally recognised regulatory authority for drugs and medical devices (collectively referred to as medical products), namely the Centre for Medical Products Regulation (CMPR). The First Five-Year Plan for Economic and Social Development of the Hong Kong Special Administrative Region (2026-2030) further affirms that the Government will comprehensively intensify the regulatory reform of medical products and enhance the regulatory regime to consolidate the regulatory functions for Chinese medicines, Western medicines and medical devices and align with international standards, develop the capacity for independent evaluation and approval of medical products, and participate actively in international regulation of medical products to pursue recognition from international authorities.
As regards the regulation of medical devices, the Government will take forward legislative reform to replace the existing voluntary MDACS with a new statutory regulatory regime for medical devices, with a view to enhancing the regulation of medical devices supplied in Hong Kong in respect of safety, quality and performance. To this end, the Chief Executive's 2026 Policy Address announced that the Government would set up the CMPR and submit a legislative proposal on regulating medical devices in 2026.
The Government is drafting the Medical Devices Bill to provide a legal basis for the proposed statutory regulatory regime for medical devices. It will maintain close communication with different stakeholders and brief the Legislative Council Panel on Health Services on the relevant content on November 13. It will listen carefully to their views in further formulating and refining the details of the proposed regulatory regime and implementation arrangements. The aim is to ensure that the system is clear, practicable, forward-looking, tailored to Hong Kong's circumstances and aligned with international standards, thereby helping to safeguard public health, promote the orderly and sustainable development of the medical device trade, and support Hong Kong in becoming an international health and medical innovation hub.
Our reply to the question raised by the Hon Nick Chan, after consultation with the Education Bureau, the Labour and Welfare Bureau and the DH, is as follows:
(1) Under the current MDACS, the listing arrangement for medical devices is based on risk levels. General medical devices are classified into Classes I, II, III and IV in ascending order of risk. In vitro diagnostic medical devices (IVDMDs) are classified into Classes A, B, C and D in ascending order of risk. Class I general medical devices and Class A IVDMDs, which carry the lowest risk, are not subject to listing; Class II to IV general medical devices and Class B to D IVDMDs, which carry higher risk, are subject to listing. Since the implementation of the system in 2004, more than 11 000 medical devices have been listed. Following the Government's announcement in 2023 that it would establish the CMPR, the number of medical devices listed under the MDACS has continued to increase. The cumulative number of listed medical devices increased from 4 782 at the end of 2023 to 11 052 at the end of October 2026, representing an increase of more than 130 per cent.
From 2023 to 2026 (up to October), the numbers of newly listed relevant medical devices are as follows:
| Category of medical device | Class of medical device | Number of newly listed medical devices per year |
|||
| 2023 | 2024 | 2025 | 2026 (up to October) | ||
| General medical devices | II | 159 | 241 | 1 129 | 836 |
| III | 120 | 234 | 727 | 571 | |
| IV | 117 | 179 | 405 | 309 | |
| IVDMDs | B | 43 | 131 | 617 | 434 |
| C | 54 | 156 | 878 | 218 | |
| D | 12 | 20 | 83 | 58 | |
As participation in the MDACS is voluntary and the system lacks statutory power, not all medical devices supplied in Hong Kong are currently listed under the MDACS. Having regard to factors such as Hong Kong's population and economic size and the experience of neighbouring economies in implementing medical device regulatory regimes, the Government's preliminary estimate is that there may be about 35 000 medical devices on the local market that will need to be registered (including products already listed under the existing MDACS, which will transition to the statutory regime as registered medical devices without having to register separately). As mentioned above, with the drafting of the Medical Devices Bill and the progress of the related legislative work, the Government will be able to better ascertain the overall supply situation of medical devices in the local market.
(2) Under the existing MDACS, there are four Conformity Assessment Bodies (CABs) recognised by the DH. They provide traders with conformity assessment services for medical devices in accordance with the essential principles of safety, quality and performance formulated by the DH to support their listing applications. These bodies must comply with the DH's requirements, including being a quality management system certification body accredited by an accreditation body that is a signatory member of the Global Accreditation Cooperation Incorporated. The DH will continue to identify suitable CABs and actively expand the number of such recognised bodies, with a view to increasing market choice and laying a stronger foundation for the device evaluation and registration mechanism under the future statutory regulatory regime for medical devices.
In addition, under the existing MDACS, the DH has imposed specific labelling requirements on listed medical devices, including indicating the specific listing number assigned by the DH and the manufacturer's information, for identification and traceability. The DH has also set up an electronic platform to facilitate traders' submission of listing applications for medical devices, reports of medical device-related adverse events, etc, as well as the DH's processing of the relevant applications and following up on the relevant cases. Drawing on its current operating experience, the DH will continue to maintain communication with the medical device industry, healthcare institutions and other stakeholders. In taking forward the statutory regulatory regime for medical devices, the DH will review and enhance the post-market monitoring system for medical devices, including exploring the interfacing of relevant information systems and the application of data, so as to more effectively monitor the continued compliance of such devices with safety, quality and performance requirements.
(3) In the report on the Mid-term Update of Manpower Projection published by the Government in September this year, projections were made on the manpower supply and requirement for the international innovation and technology centre, covering key technology areas such as life and health technology. The projection results indicate that, by 2028, the overall manpower shortage in the international innovation and technology centre will be about 12 000 to 17 000. The report also points out that life and health technology-related occupations will be in high demand in the coming three years, and that possessing regulatory knowledge related to innovation and technology is a relevant essential skill.
The Government has all along encouraged post-secondary institutions to offer programmes that meet the development needs of Hong Kong. Among other things, through the Strategic Platform on Talent Development in Higher Education under the triennial Planning Exercise, the Government maintains close communication with the University Grants Committee-funded universities and the relevant industries on manpower needs, and encourages the universities to offer relevant programmes and refine their planning and content to align with market trends. As Hong Kong takes forward the statutory regulatory regime for medical devices and endeavours to develop into an international health and medical innovation hub, the Government will continue to take forward the above work.
(4) Hong Kong has been actively participating in the Global Harmonization Working Party (GHWP), in collaboration with member countries/regions worldwide, to advance the convergence and harmonisation of global medical device regulation, including through the formulation and revision of technical guidance documents and the conduct of research projects.
This year's GHWP Annual Meeting, which coincides with the 30th anniversary of the establishment of the GHWP, will be hosted by Hong Kong. The meeting will be held in December 2026, bringing together experts from around the world in Hong Kong for high-level and professional discussions on global medical device regulation. By hosting this meeting, Hong Kong will be able to strengthen exchanges and co-operation with the rest of the world on medical device regulation and bring into play its role as a "super connector" and a "super value-adder".
With the establishment of the CMPR by the end of this year, together with the formulation and implementation of the statutory regulatory regime for medical devices, Hong Kong's regulatory regime for medical products will be further enhanced, so as to dovetail with the pace of national development and align with international regulatory systems and standards. This will lay a stronger foundation for Hong Kong to continue deepening collaboration with regulatory authorities and authoritative organisations in the Chinese Mainland and overseas on medical products, and support Hong Kong in becoming an international health and medical innovation hub.
Ends/Wednesday, November 11, 2026
Issued at HKT 15:55
Issued at HKT 15:55
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