Malaysian Medical Device Regulators Change Requirements for DoCs, AI Requests

Medical device market regulators in Malaysia have amended their Declaration of Conformity (DoC) and Additional Information Request requirements for manufacturers registering their products in the country.

Along with several minor changes made to Malaysia’s medical device registration guidelines, the responsibility for signing a DoC has been shifted from the registration applicant—usually the Malaysia Authorized Representative—to the device manufacturer. Now, DoCs must be signed and certified on manufacturers’ letterhead.

Also, Malaysian market registrants are now required to respond to any requests for additional information from the Medical Device Authority within 90 days via the MEDCAST online medical device registration system.

Medical device manufacturers and their Malaysia Authorized Representatives should familiarize themselves with these changes to ensure compliance.

Stewart Eisenhart

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