Malaysian regulators exempt low-risk medical devices from premarket review

By Stewart Eisenhart, Emergo Group

Malaysian medical device regulators have exempted all low-risk Class A medical devices from premarket review requirements, simplifying market access for these products.

The Malaysian Medical Device Authority (MDA) no longer requires Class A devices to undergo Conformity Assessment Reviews (CAB); the agency has already launched a new Class A module in its MeDC@St online registration system to reflect this change.

The new exemption applies to all Class A devices, with no differentiation for active/sterile/measuring products. However, Class A manufacturers still have other MDA requirements to meet, including appointing Malaysia authorized representatives to manage their registrations and quality management system compliance.

The MDA has not specified how the new exemption will affect Class A devices already registered for sale in the Malaysian market, but Emergo consultants in Kuala Lumpur anticipate that these devices will be left as is under the previous registration system.

For more information on Malaysian registration requirements for Class A and other medical devices, please see our regulatory process chart or read our whitepaper on Malaysian medical device approval.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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