Malaysia Though it may be among the smaller Southeast Asian countries, Malaysia has a developed med

Malaysia
Though it may be among the smaller Southeast Asian countries, Malaysia has a developed medical device markets, with a market size of $900 million. This compares to $430 million of the market in Indonesia, whose population is more than eight times bigger than Malaysia’s. With more than 28 million people and a burgeoning middle class, Malaysia’s medical device market is expected to grow 10-12 percent in the next five years.

Medical devices used to be unregulated in Malaysia but this situation is about to change. The Ministry of Health (MOH) of Malaysia decided in March to tighten control over medical devices. All medical devices now will require registration, and a new government agency will be created to regulate medical devices.

Currently, medical devices are registered on a voluntary basis in Malaysia, under the MeDVER system. During the next two years, however, all imported and locally made medical devices must be registered under the Medical Device Act 2012 (Act 737). Approval will be required from the Medical Device Control Division (MDCD), a subsidiary agency within the MOH that is responsible for monitoring the distribution of medical devices. A classification system (Class A through Class D) will be introduced for medical devices to evaluate the risk of the device. Medical devices now will be defined by the MOH as any instrument used to diagnose, prevent, monitor and/or treat disease and injury.

All parties and facilities involved in the medical device industry, including distributors, importing companies, quality assessment bodies and manufacturers, will be required to be registered and approved by the MOH. Under the Medical Device Authority Act 2012 (Act 738), a medical device authority will be created to oversee the regulations of medical products as mandated in the Medical Device Act. It also will promote the medical device market in the country.

These two acts undoubtedly will have a tremendous impact on the medical device industry in Malaysia. Quality of medical products will improve, and patents for registered medical devices will enjoy greater protection from the authorities than ever before.