While the medical devices industry in Malaysia enjoyed consistent growth over the past few years; many in the industry recognizes that the recently enforced Medical Devices Act 2012 (Act 737) will further improve export quality of medical devices from Malaysia thus driving further growth across the country and region. This means that all medical device players in Malaysia will have just under two years transition period to comply with the regulation to register their medical devices and under one year to obtain an establishment license to import and distribute medical devices locally in Malaysia.
The regulation of medical devices in Malaysia is carried out by the regulatory authority called Medical Devices Bureau (MDB), Ministry of Health. Parts of the execution and surveillance of the Regulation by the regulatory authority may be delegated to reliable private bodies called CABs. These CABs need to be designated and within surveillance of the regulatory authority. BSI has been designated as capable of assessing to both QMS ISO 13485 and Good Distribution Practices for Medical Devices (GDPMD).
Working with a CAB is essential for any medical device organization to register their medical device products, be certified to a medical device quality management system (QMS) or to attain certification for their GDPMD.