Malaysian Authorities Grant Reprieve on Device Registration
Malaysia’s Medical Device Authority has extended the application deadline for medical device manufacturers to register their products in that country.
In an announcement posted to its website, the regulator says manufacturers have until June 30, 2016, to register their devices. The original deadline, which was set by the 2012 Medical Device Act, was June 30. With this new announcement, manufacturers that submit their applications within the year timeframe may continue to import, export and market their products, pending a positive determination from the authority.
Prior to the MDA’s announcement, manufacturers that failed to take advantage of fast-track registration by June 30 would have had their products blocked from importation (). This registration option was available for devices approved for marketing in the U.S., EU, Canada, Japan or Australia. Manufacturers would then have to identify a conformity assessment body by July 1, 2018, and obtain a conformity assessment by July 1, 2020.
“Many foreign device manufacturers have not yet taken advantage of the expedited registration offered during the transition period,” explains Ames Gross, president of Pacific Bridge Medical. “Since the new regulations are still evolving, obtaining accurate information on what needs to be done has not been easy. Although the registration process itself is not overly daunting, the numerous regulatory adjustments announced in the past year and the lack of clarification on some of the guidelines might have made it difficult for device companies to follow through with their application.”
Gross adds that international companies may not have felt the need to exhaust their resources to conduct a last-minute registration for Malaysia. Regulatory affairs professionals must register their products in multiple regions, and Malaysia is a smaller market. “When Singapore offered a similar expedited registration process during their transition to mandatory registration requirements for medical devices a few years ago, many companies failed to take advantage of the opportunity then as well,” he says.