Malaysian Medical Device Regulations in Force Starting July 1

A Malaysian law requiring companies that manufacture or market medical devices in the country to register with the government goes into full effect this month, six years after it was first passed.

The 2012 law was designed to bring Malaysia, which imports 95% of medical devices used within its borders, into line with the World Health Organization’s quality and safety guidelines. It provided owners or operators of businesses involved in the production and distribution of medical devices a transition period to register with the agency created to oversee the registration process, the Malaysian Medical Device Authority. That period came to an end on July 1.

In order to comply with the law, medical devices must be registered with the Medical Device Authority of the Ministry of Health Malaysia before they can be imported for sale. Applications must be submitted via the on-line MEDCAST system by a licensed, local entity that also acts as the license holder, or Malaysia Authorized Representative.