The process to obtain Class A medical device MDA registration in Malaysia generally takes about 2 to 3 months (approximately 6 to 12 weeks). The actual time can vary based on the completeness of your application, the efficiency of your responses to any queries from the MDA, and the current workload at the MDA. Below is a breakdown of the time cycle involved:

Estimated Time Cycle for Class A Medical Device MDA Registration:

1. Pre-Application Preparation (1-3 Weeks):

   • The preparation stage involves gathering all the necessary documentation and information for the registration application, such as:
     • Product description, intended use, and classification
     • ISO 13485 certification for the manufacturer
     • Risk management files, performance, and safety data
     • Labels and instructions for use (IFU)
   • The time taken for preparation depends on the manufacturer’s readiness and whether any documentation is pending.

2. Application Submission (1-2 Weeks):

   • Once all documents are ready, the application is submitted via the MeDC@St Portal. This stage typically takes 1 to 2 weeks to complete the submission process and ensure that all forms and supporting documents are correctly uploaded.

3. MDA Review Process (4-8 Weeks):

   • The MDA will conduct a detailed review of the application, ensuring compliance with regulatory standards. The review process for Class A devices is generally quicker compared to higher-risk devices, taking around 4 to 8 weeks.
   • If the application is complete and meets the necessary requirements, the review can proceed without delays. However, if additional information or clarification is required, this could extend the review time.

4. Approval and Issuance of Certificate (1-2 Weeks):

   • After the review is completed, and assuming no issues are found, the MDA will approve the registration and issue the Certificate of Registration. This final step generally takes 1 to 2 weeks.

Summary of Total Time:

• 6 to 12 weeks is the typical time frame for the MDA to process and issue approval for the Class A medical device registration in Malaysia.

Factors Affecting the Time Cycle:

• Completeness of the Application: A complete and accurate submission can speed up the process.
• MDA Workload: If the MDA is dealing with a high volume of applications, the process could take longer.
• Response to Queries: Delays may occur if the MDA requests additional information or clarification.

By ensuring that your application is fully prepared and submitting all required documents, you can help ensure a smoother and faster registration process.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn