Malaysia Announces New Guidelines for Re-registration of Devices

Most medical devices require registration in Malaysia. Registrations are good for 5 years, and many companies are now facing re-registration. In June, the Malay Medical Device Authority released the new re-registration guidelines. Re-registration applications must be submitted via the MeDC@St application system. Any change to the product during the 5-year period must have already completed change notifications to be eligible for re-registration. The applicant or applicant’s local agent will need to submit a new conformity assessment certificate, lists of adverse vents (including international events) and how these issues were resolved over the last 3 years, and an updated Declaration of Conformity. The device’s intended use shall match the original registered device in Malaysia and must be the same as the initial approval abroad.