Towards implementation of international standards in medical devices regulation in Malaysia

摘要

Medical devices have become an integral part and a vital component of healthcare services. It plays an increasingly important role in the delivery of quality health care services. These medical devices are used for life saving and improving quality care but at the same time they pose a number of challenging safety issues to the patient in the healthcare environment. These issues become very pertinent in developing countries where health assessments are scarcely carried out with little or no regulatory control to prevent the importation and usage of substandard devices. Currently Ministry of Health, Malaysia has undertaken the task of developing the National Medical Devices Regulatory System to provide for controls relating to the quality, safety, efficacy and timely availability of medical devices. The proposed medical device regulation is a risk based regulation for pre- market, placement-on-market and post-market regulatory controls. In each phase, the medical devices are evaluated, approved and regulated in accordance with systems benchmarked to international standards. This initiative by Malaysia is towards global harmonization of medical devices regulation. It is hoped that the new regulatory system would ensure public and health safety, eliminating technical and economic barriers while promoting timely accessibility of medical devices in Malaysia.