Malaysia: Proposed Bill to Regulate Medical Devices under Way

A draft of Malaysia’s Medical Device Bill has been completed and submitted to the Attorney General for review, according to a statement made by Malaysian Minister of Health Dr. Chua Soi Lek in September 2005. One of the requirements in the proposed legislation, which is expected to be implemented from 2007, is the registration of all health care equipment with the Ministry of Health. Dr. Chua stated that although enforcement of the Medical Device Bill will not begin until 2007, voluntary registration of health care equipment would begin by the end of this year. The proposed bill will apply for all medical devices within Malaysia.

Malaysia does not presently have a medical device regulatory authority and wants to implement a system that is in line with standards of other Asian countries. Under the proposed bill, a supervisory body would be established within the Ministry of Health to ensure the safety of all health care equipment. The main responsibilities of this supervisory body would be to oversee the registration, enforcement, and monitoring of all laser and health care equipment.