LCQ9: Regulation of medical devices
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Question:
At present, Hong Kong has only put in place a voluntary Medical Device Administrative Control System (the System), and there is no legislation to regulate such devices. On the other hand, it is learnt that some merchants are promoting and marketing parallel-imported contact lenses on the Internet, but these products do not have any medical device labelling on their packaging boxes, or the labelling shows signs of alteration (e.g. "the unique device identifier" has been cut off or covered), thus making it difficult to identify whether the products belong to problematic batches, and the quality of such products cannot be guaranteed. In this connection, will the Government inform this Council:
(1) given that contact lenses is a class II medical device under the system, of the Government's control over the importation and sale (including online sale) of contact lens products;
(2) of the number of reports and requests for assistance received by the Government in the past three years in relation to parallel-imported contact lenses, as well as the categories of such cases (e.g. improper packaging labels, discomfort after use, etc.); whether it has taken law enforcement actions against merchants who have made unauthorised alterations to the packaging information of contact lenses (including parallel-imported contact lenses); if so, of the details; if not, the reasons for that; and
(3) as the Government indicated in June last year that it was conducting a comprehensive review of the proposed legislative framework for medical device regulation, whether the Government will draw up a concrete timetable for introducing legislative amendments to regulate the manufacture, importation, quality assurance, sale and post-sale follow-up of medical devices; if so, of the details; if not, the reasons for that?
Reply:
President,
In consultation with the Commerce and Economic Development Bureau, the Customs and Excise Department (C&ED) and the Department of Health (DH), the Health Bureau provides a consolidated reply to the question raised by Dr the Hon David Lam as follows:
While there is not yet specific legislation to regulate medical devices in Hong Kong, some products are already regulated by existing pieces of legislation, such as the Pharmacy and Poisons Ordinance (Cap. 138), the Consumer Goods Safety Ordinance (CGSO) (Cap. 456) and the Trade Descriptions Ordinance (TDO) (Cap. 362) etc., depending on the characteristics and features of the products concerned.
To safeguard public health, the DH has made reference to the recommendation of the Global Harmonization Task Force (now known as the International Medical Device Regulators Forum) and introduced the voluntary Medical Device Administrative Control System (MDACS) since 2004, under which a listing system for medical devices and traders as well as a post-market monitoring system for the products are put in place.
According to the prevailing MDACS, contact lenses are usually categorised as Class II (low-moderate risk) general medical devices. To apply for listing under the MDACS, a medical device must be proven to have met the requirements under the Essential Principles of Safety and Performance of Medical Devices that are adopted internationally. As for the listing system for traders (including local responsible person, local manufacturers, importers and distributors), traders must meet relevant requirements including holding a valid business registration certificate, maintaining a quality management system for supply of medical devices, and complying with post-market control for the products in order to hold them accountable for the safety of medical devices. Besides, a dedicated reporting system has been set up under the MDACS to handle the reporting of incidents pertaining to listed medical devices, with a view to enhancing protection for users via early detection of safety alerts.
On the other hand, the C&ED is responsible for enforcing the CGSO and the TDO. The safety of consumer goods which are supplied for private use in Hong Kong, if not covered by other legislation, is subject to the regulation of the CGSO and its subsidiary legislation namely the Consumer Goods Safety Regulation (CGSR). This covers contact lenses as mentioned in the question.
Pursuant to the CGSO, manufacturers, importers and suppliers should ensure that the consumer goods they supply are reasonably safe. The CGSR stipulates that any warning or caution marked on the package of consumer goods must be in both the English and the Chinese languages in a legible and conspicuous manner. Covering both goods and services, the TDO prohibits specified unfair trade practices deployed by traders against consumers, including false trade descriptions, misleading omissions, aggressive commercial practices, bait advertising, bait-and-switch and wrongly accepting payment, which are applicable to the commercial practices of both physical and online traders.
From 2022 to 2024, the C&ED did not receive any complaint on the product safety of contact lenses, but received six complaints of suspected contravention of the TDO. Upon investigation, five cases were closed due to insufficient evidence, with the remaining one under investigation.
Looking ahead, the DH has announced the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) by the end of 2026, with regulation of medical devices as part of its purview. The Government is taking forward preparatory work for the relevant legislation at full steam having regard to the latest international trends in regulation of medical devices in recent years, and will comprehensively review the proposed legislative framework. It is expected that the legislative proposal could be submitted to the Legislative Council within the next year so as to dovetail with the timetable for establishing the CMPR. Upon legislation, all medical devices supplied in Hong Kong, unless otherwise exempted, must be registered, thereby ensuring the compliance with relevant standards in safety, quality and performance.
Ends/Wednesday, July 9, 2025
Issued at HKT 15:30
Issued at HKT 15:30
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