LCQ6: Regulation of medical devices
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Question:
The Government put forward a proposed regulatory framework for medical devices last month. Quite a number of members of the beauty industry have relayed to me that at present, beauticians commonly use various types of high-technology devices for cosmetic purposes, and many of them have taken courses and obtained certificates of qualification on the operation of such devices. However, such devices will be categorised under the new legislation as medical devices the use of which requires supervision on site by a registered medical practitioner. They are worried that upon the implementation of the new legislation, quite a number of beauty salons may close down as they fail to recruit medical practitioners to station on site or cannot afford the relevant expenses. Consequently, the livelihood of many beauticians will be affected and the development of the industry will be hindered. In this connection, will the Government inform this Council:
(1) given that there is currently no internationally adopted and full-fledged regulatory approach for medical devices, whether the authorities, apart from adopting the risk-based classification rules recommended by the International Medical Device Regulators Forum and making reference to the measures and requirements implemented among the five major economies (i.e. the United States, Australia, United Kingdom, Mainland China and Singapore), have made reference to the relevant practices and regulations of other overseas countries or regions when formulating the aforesaid regulatory framework; if so, of the relevant countries and regions, and the details;
(2) whether it has assessed the impacts to be brought about by the aforesaid regulatory framework on the business environment of the medical profession, the beauty industry and their related industries, the consumers receiving cosmetic services as well as the Hong Kong economy; if so; of the details; if not, the reasons for that; and
(3) whether it has studied the feasibility of adopting two separate frameworks for regulating matters (including definition, registration, sale and use) concerning medical devices and devices for cosmetic purposes; if so, of the details; if not, the reasons for that?
Reply:
President,
Currently, there is no specific legislation to regulate medical devices in Hong Kong except for those devices which contain pharmaceutical products or emit ionising radiation. To protect the safety and health of the public, there is a pressing need to impose "pre-market control" and "post-market control" for all medical devices, as well as "use control" for specific medical devices.
The Government conducted a Business Impact Assessment between 2011 and 2013 to assess the impact of the proposed statutory regulatory regime for medical devices on the trade. Stakeholders interviewed generally supported enacting legislation to regulate medical devices, as the safety and quality of medical devices placed on the market could be ensured through regulation, thereby protecting public health and reducing patients' risk of complications and injuries caused by problematic medical devices. Besides, Hong Kong has far lagged behind other places in terms of regulating medical devices. The proposal will help bring Hong Kong on par with other major markets in the regulation of medical devices, thus raising industrial standards and facilitating development of the industry.
Recently, we received views from different sectors on the regulation of medical devices, to which I would like to respond. We observe that some medical devices are frequently used for non-medical purposes, of which mostly for cosmetic purposes. The Consumer Council has established an information exchange mechanism with the Department of Health (DH) since October 2012. As of February 5, 2017, the mechanism had recorded a total of 164 complaints by consumers on adverse events related to cosmetic procedures performed at beauty parlours, a large proportion of which involved the use of energy-emitting apparatus (100 complaints). Of these cases, most of them were performed by non-registered healthcare professionals (HCPs). In this connection, to protect public health, there is a need to impose "use control" on specific medical devices which are often used by non-registered HCPs for non-medical purposes. There is a general consensus on the above need, although different sectors have different views regarding "use control" categorisation of the devices.
Besides, some organisations consider that separate regulatory regimes should be put in place respectively for devices used for medical purposes and those used for cosmetic purposes. The definition of "medical devices" made under the current proposed regulatory framework adopts the comprehensive definition of medical device formulated by the International Medical Device Regulators Forum (IMDRF). The term "medical device" generally refers to any instrument, apparatus or appliance that is used for diagnosis, treatment or monitoring of diseases and injuries. It also covers devices that are used for the purposes of investigation, replacement, modification or support of the anatomy or physiological process of the human body. As certain devices used in cosmetic procedures such as lasers, intense pulsed light equipment and device emitting micro-current achieve cosmetic effect through medical means such as modifying the anatomy or physiological processes of human bodies by the energy emitted, they therefore fall under the definition of "medical device" stipulated by IMDRF. Generally speaking, the level of energy output used for cosmetic purposes and that used for medical purposes for energy-emitting devices may not have significant difference. As such, the level of energy output alone cannot be used to distinguish a "cosmetic device" from a "medical device". This is also not a criteria for defining a medical device internationally.
There is currently no statutory definition or separate regulatory legislation for "cosmetic device" in the international community. In case the devices used in cosmetic purposes meet the definition of "medical device", they are generally regulated under the medical device legislation internationally.
According to the Research Report on "Regulation of aesthetic practices in selected places" (the Report) published by the Legislative Council Secretariat in November 2014, in South Korea where beauty industry is flourishing, medical devices cover devices that can be used for cosmetic treatment, such as intense pulsed light devices and high-power lasers. These devices are regulated under the medical device legislation. Also, medical devices used in beauty procedures are regarded as medical procedures in South Korea, which must be carried out by medical practitioners in licensed hospitals or medical clinics. Beauty parlours can only provide general beauty services without using any medical devices. Apart from the Report above, the DH also commissioned an independent consultant from September 2015 to September 2016 to conduct a study on the use control of 20 types of selected medical devices for cosmetic purposes. It was observed that although Australia, Singapore and the United Kingdom have little or no qualification requirements for medical devices used for cosmetic purposes, use of most medical devices for cosmetic purposes in the Mainland China and in some states of the United States is restricted to medical practitioners or HCPs under supervision by medical practitioners.
In sum, there is no standardised regulatory approach on the use of medical devices for cosmetic purposes in the international community. Taking into consideration the information and views collected during the course of the study, the independent consultant conducted separate assessments respectively on clinical risk, regulatory, as well as knowledge and skills for the devices concerned when they are being used for non-medical purposes. The most stringent category of use designation among these three assessments has become the recommended use control category of the device concerned when used for non-medical purposes.
We understand that the part on "use control" may require further deliberation. In this regard, while the Government is taking forward the legislative proposal on the regulatory regime for medical devices, a multi-party platform will be set up concurrently to invite participation from different stakeholders to provide practicable and constructive views on "use control" categorisation of specific medical devices under the premise of protecting public health. Balanced participation from various sectors in the discussion of the multi-party platform will be ensured.
Ends/Wednesday, March 1, 2017
Issued at HKT 16:20
Issued at HKT 16:20
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