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Medical device complaints tackled

The Department of Health (DH) has taken appropriate follow-up action on three complaint cases mentioned in an article published by the Consumer Council today regarding the purchase of medical devices, after proactively communicating with the council on the cases.

 

In response to media enquiries on the Consumer Council’s recommendations on medical device regulation today, the Health Bureau said according to the information provided by the council to the DH, one of the complaint cases concerns the recall arrangement of the parallel import respirator parts.

 

The other two complaints are related to the terms of sales and after-sales services of medical devices and do not carry any safety, quality and performance implications of the respective medical devices.

 

The bureau said that under an established mechanism, the DH has been closely monitoring safety alerts of medical devices issued by various regulatory authorities as well as the World Health Organization, and takes appropriate action according to the actual circumstances.

 

Such action includes contacting local suppliers to follow up on necessary arrangements, notifying various stakeholders such as the Hospital Authority, private hospitals and professional healthcare institutions, and publishing safety alert summaries and special alerts on the DH website.

 

The Government has all along been planning for legislation on the regulation of medical devices, and will set up a preparatory office this year to study the potential restructuring and strengthening of the current regulatory and approval regimes for medicine, medical devices and medical technology.

 

The office will put forward proposals and steps for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR), and the regulation of medical devices will fall within the scope of the CMPR's work. 

 

The Government will consider the legislative timetable for regulating medical devices in tandem with the progress of establishing the CMPR. 

 

The bureau and the DH are now conducting a comprehensive review of the proposed legislative framework having regard to the latest international trends in regulation of medical devices in recent years, and will study various aspects of the regulation of high-risk medical devices, such that the legislative proposal may be introduced in due course.


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