Updated: 11/08/00.

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In accordance with Hong Kong's status as a Special Administrative Region of the People's Republic of China, under terms of its 1997 return to China, Hong Kong has not adopted the new, more stringent regulatory regime for medical devices that took effect on the mainland in April 2000. As of this update, Hong Kong does not require general registration of imported medical devices. The two basic requirements for medical devices imported into Hong Kong are:

demonstration of adherence to product technical standards -- usually internationally-recognized or British standards -- for sales to government entities (which account for most Hong Kong medical device purchases); and

(2) for radiation-emitting equipment, registration with the Radiation Health Unit under the Department of Health.

Technical Standards for Hong Kong Government Tenders:

Since public hospitals, which purchase via tender (see the Health Department website http://www.info.gov.hk/dh/tender.htm, or the Government Supplies Department Website http://www.ets.com.hk/), account for 70 percent of the medical equipment purchased for use in Hong Kong, it is critical for medical device companies wishing to sell consistently to Hong Kong end-users to be able to demonstrate compliance with the requisite standards that are generally specified in tender documents. All electrical equipment, including medical devices, must conform to Electrical Ordinance (Hong Kong) Cap 406 and subsidiary legislation made under the ordinance. Details regarding this ordinance are available at http://www.justice.gov.hk/home.htm. The Hong Kong government's Electrical & Mechanical Services Department (see below) can supply information on commonly required product standards upon request.

Radiation-Emitting Equipment:

The Radiation Health Unit's Irradiating Apparatus Licence Section (see below) processes applications for and handles renewal of licences required to import, sell, manufacture, produce, deal in/with, possess and/or use irradiating medical equipment. An "irradiating apparatus" is defined by the Radiation Health Unit as one intended to produce or emit ionizing radiation, or capable of producing or emitting ionizing radiation at a dose rate exceeding 5 microsievert per hour at a distance of 5 cm from any accessible point of the surface of the apparatus.

Contacts:

Department of Health of Hong Kong (General Information)
21st Floor, Wu Chung House
213 Queen's Road East
Wan Chai
Hong Kong
Dr. Monica Wong
Tel: 852-2961-8894
Fax: 852-2836-0071

Electrical & Mechanical Services Department (EMSD)
Health Sector Division
16/F Multi-Centre Block A
Pamela Younde Nethersole Eastern Hospital
Chai Wan
Hong Kong
Medical Electronics Projects and Procurement Subdivision 1
Fax: 852-2553-7887
Engineering Services Manager: Albert K.F. Poon
Tel: 852-2505-0276 / mobile 852-9138 9518
website: http://www.info.gov.hk/emsd/english/about/organisation/index.html
Radiation Health Unit - Irradiating Apparatus Licence Section

Department of Health
3rd Floor, Sai Wan Ho Health Centre
28 Tai Hong Street
Sai Wan Ho Hong Kong
Tel: 852-2836-3535 (9:00 - 12:45 & 13:45 - 17:00 weekdays, and 9:00 - 12:30 Saturdays)
Fax: 852-2834-1224
website: http://www.info.gov.hk/dh-rhu

Appendix 1: For more information read the 2005 Commercial Service Report "Selling Medical Equipment and Pharmaceutical Products to the Hong Kong Government".