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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.