On March 6, 2024, Malaysia issued Medical Device Exemption Order 2024, superseding the previous Exemption Order from 2016. This regulatory overhaul introduces an expanded framework for the exemption of certain medical devices from the registration mandate under the Medical Device Act 2012.
The most notable change of this update is the broadening of categories eligible for exemption, now including devices intended exclusively for export, those imported with the intention of re-export, and specific classifications such as orphaned, obsolete, and discontinued medical devices.
Another noteworthy change is the transition from a notification-based exemption system to one requiring the submission of an exemption application to the Malaysia Medical Device Authority (MDA). This change in procedures aims to enhance the regulatory oversight of exempted medical devices. Additionally, while the exemption from establishment license requirements has been maintained for most importers and exporters of exempted devices, those dealing with special access medical devices will continue to face licensing requirements. The Order also reaffirms that Class A medical devices are exempted from conformity assessment procedures, maintaining consistency with previous regulatory practices.
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.
Source used in the article: https://portal.mda.gov.my/index.php/announcement/285-exemption-from-registration-of-medical-devices