Health | 181
Medical Device Control
Currently, there is no specific legislation to regulate the import, sale or use of medical devices in Hong Kong except for those devices which contain pharmaceutical products, radioactive substance or that emit ionising radiation. A voluntary Medical Device Administrative Control System was established by the DH in 2004 to raise public awareness of the importance of medical device safety and pave the way to implementing the long-term statutory control.
Under this administrative control system, medical devices are classified by the DH into four classes based on their risk levels. Products that conform to requirements on safety and are effective as declared will be listed. The manufacturers and the traders must comply with the relevant listing requirements and regulatory measures, as well as report adverse incidents. The listing of high-risk and medium- risk devices, as well as high-risk vitro diagnostic medical devices is maintained by the DH. In 2010, the DH approved a total of 475 applications for listing medical devices, screened 1 749 safety alerts and processed 59 adverse incident reports.
To prepare for the statutory regulation of medical devices, the DH organised a series of seminars between August and September 2010 to gauge the views of the trade concerning the latest proposed regulatory framework. This framework was accepted by the majority of the stakeholders. The DH reported to the Legislative Council Panel on Health Services on the progress of the preparation of legislation in November 2010 and plans to carry out a business impact assessment on the regulatory proposal in 2011.
Training of Medical and Health Personnel
Doctors
Degree courses in medicine and surgery are offered at the University of Hong Kong and the Chinese University of Hong Kong, which enrolled 162 and 170 medical students respectively in 2010. During the year, 21 medical graduates with professional qualifications obtained outside Hong Kong passed the licensing examination conducted by the Medical Council of Hong Kong. Doctors are also encouraged to pursue continuing education and upgrade their professional skills and expertise in order to meet the present needs of professional practice.
The Hong Kong Academy of Medicine is an independent statutory body with the authority to approve, assess and accredit specialist training within the medical and dental professions. Its 15 colleges conduct training and examinations to award specialist qualifications to qualifying candidates.
Apart from providing the public with healthcare services, the HA also undertakes training of specialist doctors. Each year, the majority of medical graduates of the two local universities are offered appointment to the HA to receive specialist training while working in the HA. The HA recruited about 300 doctors for specialist training in 2010. To improve the remuneration package of doctors under training and to ensure they have sufficient time to complete their training, the HA