No, there is no annual review for Class A medical device MDA registration in Malaysia. However, there are certain post-registration obligations and periodic requirements to ensure that the medical device remains compliant with regulations. Here’s an outline of the process and requirements after obtaining the MDA registration:

Post-Registration Requirements:

1. Post-Market Surveillance:

   • Ongoing Monitoring: While there isn't an annual review, manufacturers are required to conduct post-market surveillance to monitor the device’s safety and performance in the market. This includes reporting adverse events, complaints, or any safety issues related to the device.
   • Manufacturers are also required to report any significant changes to the device, such as updates to the design, labeling, or intended use, and assess whether those changes require re-registration or notification to the MDA.

2. Recertification:

   • Re-registration Period: The MDA registration for a Class A medical device is typically valid for five years. After this period, you must submit a re-registration application to renew the device's registration.
   • The re-registration process involves submitting updated documentation and ensuring that the device continues to meet the relevant standards and regulatory requirements.

3. Changes and Updates:

   • Notifying MDA: If there are any significant changes to the product, such as modifications in its design, manufacturing process, or indications for use, these must be reported to the MDA.
   • Device Updates: If a device is upgraded or a new version is launched, the manufacturer may need to submit additional information or undergo a reevaluation to ensure continued compliance with MDA regulations.

4. Post-Market Activities:

   • Manufacturers and authorized representatives must keep records related to the device’s performance and safety, and be prepared for inspections or audits if necessary.
   • This could involve updating labeling, instructions for use (IFU), and safety profiles, in line with local regulatory requirements.

Summary:

• There is no annual review for Class A medical devices after they are registered with the MDA.
• Re-registration is required every five years, and the manufacturer must ensure that the device complies with post-market surveillance requirements and report any significant changes to the MDA.
• Manufacturers should stay compliant with all regulations, including ongoing adverse event reporting and product performance monitoring, to maintain their device’s registration status.

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