Malaysia Medical Device Registration Update 2024

In response to the outcomes of the MDA-CAB 2024 Workshop held on March 1, 2024, significant changes are underway in the medical device certification/registration process in Malaysia. According to an email from the Medical Device Authority (MDA) dated April 1, 2024, new procedures will be implemented to streamline conformity assessment and certification turnaround times.

Two key deliverables emerged from the workshop: the Mutual Certification Process Turnaround Time (TAT) and the Mutual Verification Report Template. In the past, sometimes the Conformity Assessment Bodies (CABs) took too long to review a dossier, or the applicant would not provide information back to the CABs in a timely manner. Under the new TAT guidelines, conformity assessment for ISO 13485 certification, GDPMD certification, technical documentation certification, and verification certification performed by Conformity Assessment Bodies (CABs) must be completed according to specific timelines.  Failure to adhere to these timelines will result in withdrawal/re-submission of the application. In addition, a new report template (the Mutual Verification Report Template), standardized by the CABs, will be used for the review process (for initial registration and re-registration), requiring applicants to integrate product information into it, per MDA requirements. With a standardized report format, it is believed that the MDA can reduce the TAT to process applications. For more information on this new template, please click here.

These changes, effective May 1, 2024, are mandatory to obtain certifications from the CABs and specifically affect the registration of Class B, C and D medical devices in Malaysia. However, the MDA-CAB will facilitate a “trial period” from May 1 to October 23, 2024, to allow applicants to familiarize themselves with the new procedures, identify any potential issues, and provide feedback. After October 23, 2024, unless there is another announcement from MDA, the applicant will need to continue filing out the template for all submissions to the CAB, regardless of whether the template or process is improved or not. Ongoing existing assessments will not be affected during this transition period.

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.