As of July 1, Malaysia is enacting a number of new regulations and policies governing how medical device manufacturers do business in the country. The tougher requirements, approved in January, are designed to help the country better compete in the sector globally.
Among the changes: a new regulatory body designed to monitor device quality. Companies must also follow changes involving medical device registration and obtaining export permits, though they will have a two-year transition period to follow new medical device registration rules.
Beyond that, small and medium-sized device companies in the country will have to comply with new quality and safety standards. The Association of Malaysian Medical Industries tells The Star that the tougher requirements will help the country compete better on the global market. Additionally, an AMMI official tells the publication that the changes will likely spur more joint ventures with foreign companies.
Medical device sales and manufacturing are increasingly becoming a global endeavor, and major multinationals are turning to emerging markets in Asia for both sales and manufacturing expansion efforts. China and India are obvious choices here, but device CEOs are also shopping around elsewhere to obtain the best value and opportunity.
And AMMI hopes they'll choose Malaysia, whose companies make things like medical gloves, catheters, surgical instruments, radiation devices and orthopedic implants. The trade group says Malaysia's homegrown industry generated sales of RM6.5 billion in 2012, about $2 billion U.S. But medical device exports from Malaysia reached RM12.9 billion, about $4 billion U.S., and exports are expected to rise steadily this year. In other words, the global device industry should take note, as another low-cost competitor emerges.
- here are device regulation details
- read The Star story