The processing time for Class A medical device registration with the Medical Device Authority (MDA) in Malaysia is generally shorter compared to higher-risk classes, due to the lower complexity and risks associated with these devices.

Estimated Processing Time:

• Class A medical device registration typically takes within 1 to 2 months from the date of submission, assuming that all documents are in order and there are no issues with the application.
• The review time can vary depending on factors such as:
  • Completeness and accuracy of the submitted documentation.
  • Any additional clarifications or requests for further information from the MDA.
  • Current workload and processing volume at the MDA.

Key Steps that Affect Processing Time:

1. Document Submission: If all required documents (such as technical files, ISO certification, etc.) are submitted correctly on the first attempt, the registration process will proceed faster.

2. MeDC@St Portal: Ensure that the online application form is correctly filled out, as incomplete or incorrect forms will result in delays.

3. Payment of Fees: Ensure that the registration fees are promptly paid via the MeDC@St portal. If there are delays in the fee payment, it may delay the processing.

4. Additional Requests from MDA: If the MDA requests additional information or clarifications during their review, this could extend the processing time.

5. Authorized Representative (AR) Involvement: If you're using an Authorized Representative (for foreign manufacturers), their timely submission and involvement can help expedite the process.

Timeline Summary:

• Normal Processing Time: 1 to 2 months.
• Possible Delays: If there are missing documents, or if further clarification is required by the MDA.

After approval, the MDA will issue the Medical Device Registration Certificate, allowing you to legally market your Class A medical device in Malaysia.

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