The time cycle for obtaining Class A medical device registration with the Medical Device Authority (MDA) in Malaysia can vary depending on several factors, including the completeness of the submission, the responsiveness to any queries, and the workload of the MDA. However, based on general timelines, the process for Class A devices is typically faster than for higher-risk devices.

Estimated Time Cycle for Class A Medical Device MDA Registration:

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

   • Before applying, you must prepare the necessary documentation, such as:
     • ISO 13485 certification
     • Product description, intended use, and risk management report
     • Instructions for Use (IFU) and labeling
     • Device safety and performance information
   • This step depends on how quickly the manufacturer or local representative can gather the required documents.

2. Application Submission (1-2 Weeks):

   • Once the documentation is ready, you can submit your application via the MeDC@St Portal. The submission involves filling out forms and uploading all required documents.
   • This typically takes about 1-2 weeks, depending on how quickly the necessary forms are completed and documents are submitted.

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

   • The MDA will conduct a document review to ensure all required information is provided and meets regulatory standards.
   • For Class A devices, the review process is usually faster than higher-risk classes. On average, it may take 4 to 8 weeks for MDA to complete the review and either request additional information or approve the device for registration.
   • If the documentation is complete and meets the requirements, the process could be at the shorter end of this range. Delays could occur if additional information or clarification is needed.

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

   • After the review, if the MDA finds everything in order, they will approve the registration and issue the Certificate of Registration.
   • The issuance of the certificate typically takes about 1-2 weeks once the review is complete.

Total Estimated Time:

• 6 to 12 weeks (approximately 2 to 3 months) is the typical time frame to obtain the MDA registration for a Class A medical device in Malaysia, from the initial preparation to receiving the registration approval and certificate.

Factors That May Impact Time Cycle:

• Completeness of Submission: A complete and well-prepared application will likely be processed faster.
• MDA’s Review Queue: If MDA is handling many applications, it could take longer, though Class A devices generally have shorter processing times compared to higher-risk devices.
• Response to Queries: If the MDA requests additional information or clarification, the time taken to respond can extend the overall timeline.

By ensuring all required documentation is in order and submitting the application promptly, the process for obtaining Class A medical device registration can be streamlined and efficient.