Hong Kong Takes Steps towards Legislated Medical Device Regulations

In July 2003, Hong Kong’s Department of Health (DH) and the Electrical and Mechanical Services Department (EMSD) together released a consultation document entitled “Regulation of Medical Devices in Hong Kong.” Currently, Hong Kong does not have any specific legislation which regulates the importation or sale of medical devices except those containing pharmaceutical products or radioactive substances.

The lack of pre-market and post-market surveillance of medical devices in Hong Kong is a potential hazard to public health. Thus, the Hong Kong government is taking steps to implement mandatory regulations on medical devices by first consulting the local medical device industry. The DH had been accepting views and comments regarding their proposed regulations up until September 30, 2003.

Much of the proposed medical device regulations put forth by the DH resemble those recommended by the Global Harmonization Task Force (GHTF). These include medical device classification based on degree of risk when applied to the human body (Class I being of lowest risk, with products such as bandages and walking canes, and Class IV being of highest risk, with products such as cardiac pacemakers and implantable electrodes.). Other proposed regulations include implementing systems for pre-market and post-market surveillance, registration of manufacturers and importers, and mandatory certification of personnel operating higher classed medical devices.

In order to transition to the long-term mandatory regulatory system, the DH is currently inviting manufacturers and importers of medical devices to list their products voluntarily. The listing would be made available to the public for consumer reference. Implementation of this administrative control system is expected to begin in 2004 when the DH will start listing Class IV medical devices, their importers, manufacturers, and authorized representatives. Listing of Class III and Class II devices will follow in stages. The DH is also planning to set up an adverse reaction reporting system. The temporary administrative control system will later be replaced by the fully legislated mandatory requirements.

In a 2002 survey of medical devices marketed in Hong Kong conducted by the EMSD, 31%, 60%, and 9% of medical devices belonged to Class I, Class II and III, and Class IV categories respectively. The survey also found that the majority of Hong Kong’s medical devices were imported, mainly from the US, the EU, Japan, and Mainland China.