26 November, 2004

The Government intends to implement by phases the Medical Device Administrative Control System (MDACS) under the ambit of the Department of Health (DH).

Speaking at a press conference today (November 26), the Deputy Director of Health, Dr T H Leung, said: "MDACS imposes control along the chain of supply of medical devices according to a risk-based framework with reference to harmonised international standards. The system is drawn up after a public consultation exercise carried out last year. Such a system can avoid unnecessary burden on the trade."

Under the administrative control system, every medical device listed shall have a local responsible person who will keep track of the distribution and to report any adverse incident related to the device. This listing system largely enhances the ability of the Government to monitor the use of medical devices in the local market.

"With the introduction of the MDACS, we are confident that our surveillance and response capacity for adverse incidents relating to medical devices will be strengthened considerably. Together with the effort of our local and international partners, we are fully prepared to launch the administrative control system on medical devices," Dr Leung said.

He said traditionally medical devices are confined in health care facilities. However, with the advancement of science and technology and the globalisation of trade, there are now more than 20 000 types of medical devices in the local market and many of them are readily accessible by the public.

The regulatory authority needs to balance consumers' choice for access to latest technology on the one hand and protecting consumers from unsafe and ineffective medical devices on the other.
"In devising the MDACS, we have taken into account overseas experience, the health needs and circumstances of our local population as well as relevant recommendations of the relevant international authority - Global Harmonization Task Force (GHTF) on medical devices.

"We strive to safeguard public health by ensuring local consumers have timely access to medical devices that are safe, efficacious and perform as intended," Dr Leung said.

Dr Leung said the first phase of the MDACS:- Voluntary Listing of Class IV (High Risk) Medical Devices will be launched on 26 November 2004. Two guidance documents for the implementation of the first phase of MDACS have been posted on DH's website (www.dh.gov.hk) to assist interested traders to submit their products for listing.

Other key features of the MDACS, to be implemented in phases, comprise:

• listing of importers;
  
• listing of local manufacturers;
  
• accreditation of Conformity Assessment Bodies;
  
• listing of Class II and Class III medical devices;
  
• implementing post-market surveillance for corrective measures, including product recall;
  
• setting up an adverse incident reporting system; and
  
• building a web site for the dissemination of important information related to the safety and requirements of medical devices for reference of health care professionals, the trade as well as the public.

Traders are encouraged to apply for listing of their medical devices accordingly. The listed medical devices will be posted on the website for public's reference in due course.