Malaysia medical device authority clarifies declaration-of-conformity rules

By Stewart Eisenhart, Emergo Group

New guidance from Malaysian medical device market regulators provides more specifics and clarity regarding Declaration of Conformity (DoC) requirements for registration in the country.

In particular, the Medical Device Authority (MDA) guidance clarifies the role of Responsible Persons in the Malaysian registration process. Typically, according to the guidance, Responsible Persons are chief executives, managing directors or general managers of applicant companies.

More specific information on who should sign DoC documents attesting that devices conform to Malaysian Essential Principles of Safety and Performance are also provided in the guidance. For foreign manufacturers, anyone in a “top management” position at the applicant company qualifies as a DoC signatory.

The DoC guidance follows clarification from the MDA in late 2015 on the agency’s conformity assessment process for Malaysia medical device registrants; such efforts by regulatory authorities to make their requirements clearer are welcome moves.

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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