Dear Medical Device Sector Stakeholders,

IMPORTANT NOTICE: EXPIRY OF REGISTRATION FOR NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. AS A CAB UNDER THE ACT 737

Greetings from the Authority. We hope this message finds you well.

We are writing to inform you about a significant development regarding a Conformity Assessment Body (CAB) registered under the Act 737, NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. (Registration Number: MDA/CAB-018). As of December 17, 2023, this organization has officially expired its registration validity as a CAB.

To ensure a smooth transition for all affected clients of NEWERA INTERNATIONAL CERTIFICATION SDN. BHD., we strongly recommend the following actions:

 i.Transfer Certification to a New CAB: Affected clients are advised to promptly initiate the process of transferring their conformity assessment certificates to a new, registered CAB. This will  help maintain compliance with regulatory requirements and standards.

 ii.Engage a New CAB: Alternatively, clients may opt to engage a new CAB that meets your specific needs and regulatory obligations. It is essential to verify the registration status and eligibility of the chosen CAB before proceeding.

We understand that this situation may cause inconvenience, and we are committed to assisting you throughout this transition period. Should you have any questions or require further guidance, please do not hesitate to reach out to our dedicated support team at cab.registration@mda.gov.my.

Your commitment to maintaining the highest standards in the medical device sector is greatly appreciated. We encourage you to act promptly to ensure uninterrupted compliance and regulatory adherence. Thank you for your attention to this matter.

Best Regards,

"MALAYSIA MADANI"

"BERKHIDMAT UNTUK NEGARA"

CAB Registration Unit (CABRU)

Pre-Market Control Division (BKPP)

Medical Device Authority (MDA)

Ministry of Health (MoH)