Five years after Malaysia’s Medical Device Authority (MDA) made it mandatory for foreign manufacturers to register their medical device products to access the country’s market, the authorizations are expiring, but regulators have yet to make it possible for many to be renewed.
The renewals appear to be held up by a process that is being stymied by an out-of-date online system. There is no indication that the MDA will not renew authorizations that meet the standards it has established. Those standards include submission of basic medical device information, conformity assessment of quality management systems, and letters of authorization. But the MDA faces a massive backlog, as foreign manufacturers seek to renew registrations of their medical device products.
In many cases, renewals have become very similar to new registrations.
The country’s medical device regulatory system was first established in 2012, replacing a system of voluntary registration that had prevailed in Malaysia until then. After a years-long period of transition, the first mandatory device licenses were issued in July 2016.