The Government has issued a consultation paper seeking the public's views on the proposed regulation of the manufacture, import, sale and use of medical devices.

Deputy Director of Health Dr PY Lam said the proposals aims to safeguard the health and safety of the public.

He said the proposed controls take into account the risks associated with the use of the devices. The level of regulatory control increases in step with the degree of risk, taking into account the benefits the use of the device offers.

It is proposed that medical devices be classified into four classes, depending on the degree of risk. Low-risk devices belong to Class I, medium-risk devices to Class II and III, and high-risk devices 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 requires that only medical devices which meet safety, quality and effectiveness requirements be allowed for sale in Hong Kong.

In addition, products of medium and high risks are required to be registered. Their manufacturers and importers are also required to register.

The paper also proposes 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 to 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 setting up 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 low-risk category, registration would not be required. 

However, devices that emit energy or are invasive to the human body will be subject to control. The Undesirable Medical Advertisements Ordinance (Cap 231) will continue to regulate medical devices advertisements.

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. 

The listing of the other categories will be conducted in phases.

Three public forums will be held on July 22, 25 and 31 from 3pm to 4.30pm 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 the Department of Health'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 the department's homepage.