Replies to LegCo questions

LCQ8: Regulation of medical devices

Following is a question by the Hon Li Kwok-ying and a written reply by the Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council today (November 8):

Question:

It has been reported that colon hydrotherapy, which has become increasingly popular in recent years, is claimed to be effective for detoxification, body trimming and disease prevention. However, according to the medical profession, there is a lack of scientific and medical proof to support the claim. Moreover, recently there was a case in which the consumer concerned had contracted diseases after receiving such therapy. In this connection, will the Government inform this Council:

(a) whether the Department of Health has received a complaint from the above-mentioned consumer who had contracted diseases after undergoing colon hydrotherapy; if it has, of the date on which the complaint was received, the follow-up action and whether the sectors concerned and consumers have been notified of the case; if so, of the arrangements for making such notification; if not, the reasons for that;

(b) given that the public is increasingly concerned about the problems arising from the improper use of medical devices such as those mentioned above, and the Administration has undertaken to expedite the conversion of the voluntary Medical Device Administrative Control System into a statutory registration system, whether it will consider amending the existing legislation to strengthen the regulation of medical devices during the transitional period; and

(c) whether it has considered how a balance between the impact of regulating medical devices on the development of the relevant sectors and the protection of consumers' interests can be struck; if so, of the results of its consideration?

Reply:

Madam President,

(a) In early November 2005, the Department of Health (DH) received a complaint involving a colon hydrotherapy centre referred by the Hong Kong Doctors Union. DH then referred the complaint to the Police for follow-up action. After investigation, the Police found no evidence of illegal medical practice by the colon hydrotherapy centre and no evidence to substantiate the complainant's allegation. Generally speaking, if evidence shows that a complaint is of public health significance, DH will publicise the matter. In this case, however, since there was no evidence to prove that the infection was related to colon hydrotherapy, DH did not notify the trade or the public.

(b) At present there is no legislation in respect of the regulation of medical devices. A new ordinance needs to be enacted before any statutory regulatory framework can be put in place. As set out in the 2006-07 Policy Agenda, we shall consult stakeholders on the statutory framework in respect of regulating medical devices in the coming year.

(c) The purpose of regulating medical devices is to safeguard the health and safety of patients, device operators and the public. At the same time, we also need to ensure our continued access to new technologies and maintain a good business environment. Before drafting the legislation, we will conduct a regulatory impact assessment on the regulation of medical devices.


Ends/Wednesday, November 8, 2006
Issued at HKT 13:00

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