Medical Devices in Malaysia To Register With Health Ministry

Malaysia will soon introduce its Medical Devices Act by the end of 2011. This Act is expected to be established when the current Medical Devices Bill 2008 is presented to the Malaysian Parliament either at the end of March 2011 or in June 2011.

The new Medical Devices Act will require imported and local medical devices to be registered with the Health Ministry of Malaysia. This is to ensure quality products in medical treatments, as well as to legally protect the medical devices under the country’s patent law. Currently, registration of medical devices is not mandatory in Malaysia.

Major medical devices manufactured in Malaysia include syringes, surgical equipment, blood transfusion
sets, blood pressure transducers, dialysis solutions, diagnostic radiographic equipment and orthopedic products. Apart from these, Malaysia is also a major exporter of catheters and surgical gloves.

The Malaysian medical device market is currently estimated at $600 million. The market is projected to increase to $700 million by the end of 2011. This will be aided by government investments in healthcare, increasing number of health insurance policy holders as well as greater private medical spending by middle-income Malaysians.