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The Department of Health (DH) today (July 4) released a public consultation paper on the proposed regulatory framework on medical devices in Hong Kong.
"The consultation paper set out the proposed regulation on the manufacture, import, sale and use of medical devices with an aim to safeguard the health and safety of the public," the Deputy Director of Health, Dr P Y Lam, said at a press conference launching the consultation that lasts until September 30.
"We welcome views and comments from the public, medical device trade and industry, health care professionals, beauty parlour operators and interested bodies. In addition, public forums will be held to gauge opinion on the paper. We will take into account all views collected when drawing up the final regulatory framework," Dr Lam added.
Following the recommendation of the Consultation Document on Health Care Reform released in 2000, DH and the Electrical and Mechanical Services Department conducted a comprehensive review of the present statutory regulations on the use of medical devices. Regulatory practices overseas were also studied.
Certain problems relating to medical devices in Hong Kong are identified. Firstly, there is no pre-market control to assess the safety, effectiveness and quality of medical devices to safeguard public health. Secondly, there is also an absence of specific control on the use of selected medical devices by non-medical professionals to ensure the safety of consumers. Thirdly, there is no formal adverse incident reporting and proactive surveillance system. Lastly, the review indicated that there is inadequate product information for the public and operators to make informed choices on the safe use of medical devices.
In view of such deficiencies, a regulatory system to control the sale and use of medical device in Hong Kong is necessary to safeguard the health and safety of the public. Medical devices should be safe, effective and of good quality.
"The proposed controls take account of the risks associated with the use of the device. The level of regulatory control increases with increasing degree of risk, taking into account the benefits offered by the use of the device," Dr Lam explained.
He said the approach is in line with the model recommended by the Global Harmonization Task Force, which is an international organization encouraging convergence in regulatory practices to ensure the safety and effectiveness of medical devices.
To institute different levels of control, it is proposed that medical devices should be classified into four classes, depending on the risks associated with the device. Low risk devices belong to Class I, medium risk devices belong to Class II and III, and high risk devices belong to Class IV.
The scope of control covers pre-market control, the control on the use of selected medical devices and post-market control. Pre-market control in general required that only medical devices which meet requirements on safety, quality and effectiveness be allowed to be sold in Hong Kong. In addition, products of medium and high risks are required to be registered in this context. Their manufacturers and importers are also required to have registration.
The paper also proposed to limit the use and operation of certain high risk medical devices to specified personnel. For instance, the use of Class 3B and 4 Lasers and intense pulsed light devices are be used by trained personnel only. A code of practice setting out the requirements on device operators in terms of training, safety precautions and maintenance of devices will also be promulgated.
As for post-market control, the paper proposed the setting up of a proactive surveillance system and an adverse incident reporting system to prevent recurrence of medical incidents relating to medical devices.
For non-orthodox devices that belong to the and low risk category devices, registration would not be required. However, devices that emit energy or are invasive to human body will be subject to control. Advertisements on medical devices will continue to be regulated by the Undesirable Medical Advertisements Ordinance (Cap 231)
Regarding the timeframe, an administrative control system is proposed to be implemented in 2004 starting with the listing of high-risk (Class IV) medical devices, as well as the importers and manufacturers of high-risk medical devices. After review, the listing of the other categories will be conducted in phases.
Three public forums will be held on July 22, 25 and 31 from 3 pm to 4.30 pm at the Auditorium, Room 302, 3/F, MacLechose Dental Centre, 286 Queen's Road East, Wan Chai. Due to limited seating capacity, prior registration is necessary and interested parties are advised to contact DH's Medical Device Task Force at 2961 8548 for seat reservation.
Copies of the consultation paper are available at all District Offices and can be downloaded from DH's homepage (http://www.dh.gov.hk).
Views and comments should be sent on or before September 30, 2003 to DH by post (Medical Device Task Force, Department of Health, 21/F, Wu Chung House, 213 Queen's Road East, Wan Chai, Hong Kong); by fax to 2573 7745 or 2157 9493; or by e-mail to mdtf@dh.gov.hk
End/Friday, July 4, 2003
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