Malaysia will see its medical device market grow from just over US $1 billion to $3.8 billion by 2020, according to a new report. Malaysia’s Ministry of Health (MOH) says that better access to healthcare and an aging population, along with new medical device regulations, will fuel the growth.
This is good news for foreign medical device companies, who supply most of the high-risk devices that cater to an older and richer population. Most devices manufactured in Malaysia are low-risk, including catheters and examination and surgical gloves.
But that may be changing. To increase Malaysia’s share of its medical device market, the government has targeted certain high-risk devices for increased local production, including cardiovascular devices and orthopedic devices.
All devices — whether imported or locally produced — will have to be registered with the MOH by July, 2013. In the past, manufacturers were not required to register any medical devices sold in Malaysia. Under the Medical Device Act 2012, devices must be registered into Classes A through D based on levels of risk and intended use. Manufacturers, distributors, importers and conformity assessment bodies will also have to obtain establishment licenses from MOH.
Malaysia’s medical device evaluation process is quite similar to Singapore’s. It has abridged routes for devices already approved by regulatory bodies in Japan, Australia, Canada, the US and the EU. Further, much of the paperwork required for registration falls under the ASEAN Common Submission Dossier Template (CSDT).
Medical device manufacturers have a transition period of two years to register all devices in Malaysia. Distributors, importers, and local manufacturers have a transition period of one year to obtain establishment licenses. Those who fail to register their products by November 2014 face a maximum fine of $63,000 and three years’ imprisonment.