Replies to LegCo questions

LCQ8: Regulation of medical devices

Following is a question by the Hon Michael Tien and a written reply by the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today (July 2):

Question:

The Government established the Steering Committee on Review of the Regulation of Private Healthcare Facilities (Steering Committee) in October 2012, and set up the Working Group on Differentiation between Medical Procedures and Beauty Services (Working Group) under the Steering Committee to differentiate between medical treatments and ordinary beauty services as well as to make recommendations on the regulatory approach. The Working Group has recommended to stipulate that only healthcare professionals may operate energy-emitting devices, some of which involve 15 cosmetic procedures. However, the beauty industry does not concur with such a recommendation. In this connection, will the Government inform this Council:

(1) of the detailed justifications for the authorities' inclination to define all energy-emitting devices (e.g. laser and intense pulsed light equipment) as medical devices under the new regulatory regime;

(2) whether the authorities will consider allowing beauty practitioners who have received appropriate training and obtained relevant qualifications to operate energy-emitting devices under the new regulatory regime;

(3) whether it will adopt the Working Group's recommendation to set up an expert panel under the new regulatory regime to advise on the risk levels of, and the appropriate control over, the application of innovative devices for new cosmetic procedures; if it will, of the details; if not, the reasons for that; and

(4) given that the authorities have proposed to set up, under the new regulatory regime, an advisory committee comprising members from relevant stakeholder groups to advise the Department of Health on the classification of medical devices and issues relating to the implementation and administration of the future legislation, whether the authorities will undertake that members of that committee will include representatives of the beauty industry; if they will make such an undertaking, of the respective proportions of various types of stakeholders (e.g. the beauty industry, medical practitioners and the academia) in the composition of that committee?

Reply:

President,

My reply to the question raised by Hon Michael Tien is as follows:

(1) and (2) The Department of Health (DH) has established the existing voluntary Medical Device Administrative Control System (MDACS) having regard to the recommendations of the Global Harmonization Task Force (now the International Medical Device Regulators Forum). Under the MDACS, the term "medical devices" generally refers to any instrument, apparatus or appliance that is used for diagnosis, treatment or monitoring of diseases and injuries. It covers devices that are used for the purpose of investigation, replacement, modification or support of the anatomy or physiological process of the human body. These range from simple devices like hot/cold pads to sophisticated devices like implantable defibrillator and high power laser machines. Devices used for the examination of human specimens are also included under the term. The classification of an energy-emitting device as a medical device would depend on whether its functions fall within the above definition of "medical devices". Certain energy-emitting devices commonly used in beauty procedures (such as high-power medical lasers and intense pulsed light equipment) are defined as medical devices due to their use for modifying the anatomy of human bodies.

Following the incident in October 2012 involving a beauty centre inappropriately offering high-risk medical procedures, the Administration established the Working Group on Differentiation between Medical Procedures and Beauty Services (Working Group) under the Steering Committee on Review of the Regulation of Private Healthcare Facilities. The Working Group has examined the safety and health risks of devices commonly used in beauty procedures such as high-power medical lasers and intense pulsed light equipment. After discussion, the Working Group considered that given the heterogeneity of the energy-emitting devices and their application in beauty procedures, the use of these devices should be regulated and this should be dealt with separately under the legislation on medical devices. The Working Group suggested that the Administration should conduct a more detailed study to examine overseas experience and practices and consider the scope of control over the use of these medical devices.

Having regard to the deliberation result of the Working Group, the Administration is preparing to engage a consultant to conduct a detailed study on the control of the use of these devices. A set of criteria will also be formulated to assess if the medical devices should be put under control, and the competencies and qualifications required for operating such devices. In the course of the study, we will fully consult the trade and stakeholders concerned, including the beauty industry. Generally speaking, medical devices (including energy-emitting medical devices) are intended to be used for medical purposes. The objective of imposing control over the use and operation of medical devices is to prevent unnecessary harm or complications arising from their improper use. In the absence of control arrangements, the operation of a medical device by a person without proper training or qualification may pose health risks to the operator himself/herself and his/her clients. Subject to the results of the consultant's study, non-registered healthcare professionals can be qualified to operate selected medical devices after completing the specified training and assessments.

(3) and (4) The Government will consider the recommendations of the consultant and set up an advisory committee which will provide the DH with professional advice on issues relating to the implementation of the legislation to be enacted in future (e.g. marginal cases of classification of medical devices or issues relating to the regulation of medical devices which may be used in beauty procedures). Composition of the advisory committee will depend on the subjects to be discussed. It will be comprised of experts of different fields and members from the relevant stakeholder groups such as organisations of the trades concerned (including the beauty industry), medical associations, engineering institutions and academia.

Ends/Wednesday, July 2, 2014
Issued at HKT 18:06

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