Following is a question by the Hon Nixie Lam and a written reply by the Secretary for Health, Professor Lo Chung-mau, in the Legislative Council today (January 28):

Question:

     It has been reported that in recent years, many different types of medical and health devices or products have emerged in the market, of which some have employed innovative technologies developed by local start-ups and university research teams. However, some members of the medical profession have relayed that the efficacy of such devices or products is not sufficiently supported by independent clinical research and other medical data. There are views that the promotions of such devices or products claiming to serve specific medical purposes may lead to misunderstanding among the public (especially the elderly) about their actual efficacy, rendering it difficult to protect the rights and interests as well as safety of consumers. In this connection, will the Government inform this Council:

(1) regarding the increasing number of devices or equipment incorporating innovative technologies and claiming beneficial health effects emerging in the market, of the mechanism put in place by the Government to assess and verify the safety of the technologies employed, as well as whether the claimed effects are supported by scientific evidence, prior to extensive marketing of such products;

(2) given that the existing Undesirable Medical Advertisements Ordinance (Cap. 231) (the Ordinance) regulates advertisements relating to "medicine, surgical appliance or treatment", whether medical and health devices or products employing newly developed innovative technologies are regulated by the Ordinance; if so, regarding such devices or products containing promotional statements about the prevention, improvement or alleviation of diseases, how the authorities determine whether such promotions have contravened the Ordinance, and of the monitoring measures in place to identify and follow up on non-compliant promotions; if not, whether the authorities will consider reviewing the existing relevant legislation to step up the regulation of such devices or products;

(3) of the number of cases in which the requirements relating to "diseases and conditions in respect of which advertisements are prohibited or restricted" under the Ordinance were contravened in the past five years, the relevant penalties imposed, and the contents of such advertisements; and

(4) to encourage innovations while safeguarding public health, whether the Government will adopt a more forward-looking regulatory mechanism (e.g. providing early legal advice to research teams developing health-promoting devices or products to prevent such products from contravening the relevant ordinances), and step up public education to remind members of the public to exercise greater caution in evaluating the efficacy of emerging devices or products claiming beneficial health effects?

Reply:

President,

     The reply, in consultation with the Commerce and Economic Development Bureau and the Department of Health (DH), to the question raised by the Hon Nixie Lam is as follows:

     Hong Kong is committed to developing into an international health and medical innovation hub, where technological innovation is complemented by institutional innovation, fostering new quality productive forces in biomedical technology and expediting patients' access to advanced diagnostic and treatment services. The Government is expediting the reform of the approval mechanism for drugs and medical devices to raise regulatory standards and spearhead the translation of research findings on innovative drugs and medical devices into practical applications.

     The Chief Executive's 2025 Policy Address announced that the Government will set up the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026 and submit the Medical Products Regulation Bill to the Legislative Council, in order to systematically consolidate the regulatory functions for Western and Chinese medicines as well as medical devices. The objective is to establish the CMPR as an internationally recognised regulatory authority for medical products as soon as possible and foster the development of Hong Kong into an international health and medical innovation hub. The Health Bureau and the DH are making preparations for legislating medical device regulation. A comprehensive review of the proposed regulatory framework is being conducted, having regard to international regulatory trends in recent years. A legislative proposal will be submitted to the Legislative Council this year.

Regulation of medical devices

     While there is no specific legislation to regulate medical devices in Hong Kong, some products are regulated by existing pieces of legislation, such as the Pharmacy and Poisons Ordinance (Cap. 138), the Consumer Goods Safety Ordinance (Cap. 456) and the Trade Descriptions Ordinance (Cap. 362), depending on the characteristics and features of the products concerned. As mentioned above, it is the Government's plan to introduce a legislative proposal on regulating medical devices to the Legislative Council this year to improve the regulatory framework.

     To safeguard public health, the DH introduced a voluntary Medical Device Administrative Control System (MDACS) in 2004, drawing on recommendations from the Global Harmonization Task Force (now known as the International Medical Device Regulators Forum). The system involves approving a list of medical devices to ensure their compliance with relevant safety, quality and performance standards, establishing a trader listing system, and implementing a post-market monitoring system for products. Although there is currently no statutory regulation in place, more than 8 900 medical devices have already been listed under the MDACS. Innovative medical devices must undergo scientific validation, including clinical trials, to provide reliable data demonstrating their safety and efficacy. Members of the public in need should consult healthcare professionals such as medical practitioners before clinical use of medical devices.

Regulation on medical advertisements 

     Advertisements for innovative medical and health appliances or products are also subject to the regulation under the Undesirable Medical Advertisements Ordinance (Ordinance) (Cap. 231). To prevent the public from seeking improper management of certain health conditions, the Ordinance prohibits/restricts the publication of advertisements that will likely lead to the use of any medicine, surgical appliance or treatment for the purpose of preventing or treating diseases or conditions (note 1) specified in Schedules 1 and 2 to the Ordinance. The Ordinance also prohibits/restricts orally consumed products to make six groups of claims (note 2) specified in Schedule 4 in advertisements.

     The DH screens medical advertisements, including the overall content and individual wording, based on its established mechanism. Appropriate actions will be taken in accordance with the law against any contravention of the Ordinance. From 2021 to 2025, the DH reviewed over 200 000 advertisements published across various media in Hong Kong, including newspapers, magazines, leaflets, signs, posters, as well as radio, television and internet advertisements. Depending on the circumstances of individual cases, the DH will issue warnings or initiate prosecution proceedings based on its established mechanisms. During the aforementioned years, the DH issued over 2 200 warning letters concerning advertisements that contravene the Ordinance. After the issuance of warning letters, relevant advertisement contents suspected of contravening the Ordinance were removed or deleted. For cases where the relevant advertisement content is still not removed or deleted upon receipt of warning letters, the DH will initiate the prosecution proceedings based on its established mechanism. Upon first conviction, an offender is liable to a fine of $50,000 and imprisonment for six months; for subsequent convictions for an offence under the same provision, an offender is liable to a fine of $100,000 and imprisonment for one year.

     The Government will continue to closely monitor the regulatory measures in other jurisdictions as well as the local market situation, and will review the Ordinance as appropriate to strengthen the regulation of medical advertisements, including those relating to medical and health appliances or products.

Note 1: Diseases or conditions specified in Schedules 1 and 2, such as diseases of the heart or cardiovascular system and diseases of the musculo-skeletal system.

Note 2: Claims specified in Schedule 4, such as regulation of body sugar or glucose and/or alteration of the function of the pancreas and regulation of blood lipids or cholesterol.

Ends/Wednesday, January 28, 2026
Issued at HKT 18:45

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