Replies to LegCo questions
LCQ6: Regulation of medical devices
Following is a question by the Hon Shiu Ka-fai and a reply by the Secretary for
Food and Health, Dr Ko Wing-man, in the Legislative Council today (March 1):
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
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