Malaysia moves to bolster medical device manufacturer accountability

As medical devices increasingly flood the Malaysian market, authorities are instituting new regulations that put responsibility for ensuring the safety and efficacy of the products squarely in the hands of manufacturers.

The regulations make manufacturers accountable for handling complaints, responding to incidents and handling recalls of medical devices in accordance with the projected useful life of the medical device, whether or not they close their operations in the country or cut ties with their authorized representative.

In accordance with the regulation, the manufacturer’s responsibility ends only after it finds a new authorized representative, who then becomes responsible for post-market issues that arise with the medical device, If it does not, the manufacturer remains legally responsible for the duration of the projected useful life of the medical device.