22 November, 2015
The Secretary for Food and Health has stated that the Hong Kong government (the Administration), will soon complete a study on how to regulate high-risk medical devices. It is expected that the proposed regulations will enter the legislative process next year.
There is currently no legislation to regulate the manufacture, import, sale and use of medical devices in the territory. However, certain pharmaceutical-containing devices, or radiation-emitting devices may be regulated under the existing Pharmacy and Poisons Ordinance (Cap. 138) and the Radiation Ordinance (Cap. 303), respectively.
The proposed regulatory framework for medical devices is based upon the concept of risk management and is largely modeled on the recommendations made by international organisations such as the Global Harmonization Task Force (GHTF) (now the International Medical Device Regulators Forum (IMDRF)) and the World Health Organisation (WHO). With a risk-based classification the level of regulatory control applicable to a medical device takes account of the risk associated with the device, according to GHTF's recommended classification scheme. The proposed Hong Kong scheme is divided into three main areas of regulation: pre-market control, post-market control, and specific use control. The Department of Health will be responsible for the administration and enforcement of the scheme.
Pre-market controls will be put in place to ensure that medical devices conform to requirements on safety, performance, and quality. The Administration will continue to impose registration requirements for medical devices and in vitro diagnostic medical devices (IVDMDs) with risk levels of Class II or above and Class B or above, respectively. Device registration will be valid for a 3 year renewable period. Conformity Assessment Bodies (CABs) will be empowered to perform conformity assessment audits on medical devices. The regulations will also prohibit any misleading or fraudulent advertising of medical devices or the promotion for a non-approved use. The supply of a device for off-label use, except by a registered healthcare professional, will be considered an offence.
Under the proposals, post-market controls will enable swift control measures to be enacted against defective or unsafe medical devices. The regulations require the Department of Health to establish a post-market surveillance system to monitor the safety, performance and quality of medical devices in the local market, as well as maintain vigilance on medical devices safety alerts issued by overseas regulatory authorities.
The eventual introduction of a regulatory system for medical devices in Hong Kong will help bring the territory in line with the medical device regulations adopted by other major jurisdictions and raise industrial and clinical standards. The final implementation is predicted to result in broader economic benefits in terms of reduced morbidity and mortality.
Alison Wong, Partner, Bird & Bird
alison.wong@twobirds.com
