Devicemakers have until June 30 to register their products in Malaysia and regulators there are already anticipating a backlog of applications.
Nearly 5,000 applications for product registration have been received, but the authority had envisioned receiving more by now, says Zamane bin Abdul Rahman, chief executive of the Medical Device Authority. Many companies are waiting for fast-track registration mechanisms and guidelines that will come out by mid-April, he tells IDDM.
The registration deadline was triggered by the 2012 Medical Device Act and its implementing regulations, which included a three-year transition period.
Under the expedited mechanism, companies whose products have been certified in the U.S., EU, Canada, Australia or Japan can register without undergoing a conformity assessment in Malaysia. However, they must verify their credentials with an MDA-recognized conformity assessment body within five years, Rahman says.
Compliance Will Be Closely Monitored
Novel products are not covered by the fast-track mechanism, as they may have risks, Rahman notes. Class A products with no measuring function that are nonsterile and nonactive are exempt from registration, though firms must request exemption via forms on the authority’s website.
Devices will be monitored closely to ensure compliance with the regulations, Rahman says, adding that deviations and adverse incidents could trigger a recall.
Applications submitted by the June 30 deadline will go onto a transition list, meaning they can be sold in Malaysia pending registration, says Ames Gross, president of Pacific Bridge Medical.
Products that aren’t on the transition list will likely take a long time to register and can’t be imported into the country until they are, Gross tells IDDM. — Jonathon Shacat