Device registration in Malaysia is aided by prior approval in the EU/US. An EC Certificate (EU CE Marking) or EC Declaration of Conformity is recognized by the Malaysia Medical Device Authority (MDA) as an approved type for the conformity assessment process for medical device registration in Malaysia.
The MDA has revised the registration and re-registration process of medical devices using EC Certificates that have expired. This update is applicable to all classes of medical devices and IVDs. For manufacturers that rely on an EU EC certificate as a route for the assessment of their registration in Malaysia, the MDA has clarified that during new registration or re-registration, the expired certificate under Directive 90/385/EEC, 93/42/EEC, and 98/79/EC can be accepted provided certain conditions are satisfied. These conditions include:
- The device must still comply with the respective EU directives
- The design of the device has not been changed significantly
- It does not pose any unacceptable risks.
In addition, the manufacturer must submit some supporting documentation, including confirmation letters from the notified bodies or a self-declaration letter.
Applications already completed with the EU MDD EC certificate will remain unaffected. However, when the time for re-registration comes, an MDR certificate shall be provided, or the 3 aforementioned conditions must be met.
This notification ensures a smooth transition amidst the ongoing challenges with the implementation of the EU MDR and IVDR, while ensuring the availability of needed medical devices in Malaysia.
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.