The time it takes to register a Class B medical device in Malaysia typically ranges from 3 to 6 months, depending on the completeness of the submitted documents and the complexity of the review process. The timeline can be extended if additional information or clarifications are required by the Medical Device Authority (MDA).

Breakdown of the Registration Timeline

1. Document Preparation:

   • Preparing technical documentation, clinical evidence, and other required materials can take several weeks to months, depending on the readiness of the documents and testing results.
   • For companies familiar with the process or with pre-existing documentation (e.g., from other jurisdictions), this stage can be faster.

2. Submission via MeDC@St:

   • Once the required documents are prepared, the submission process via the MeDC@St system is generally straightforward and can be completed within a few days.
   • Make sure that all documents are accurate and complete to avoid delays at later stages.

3. MDA Review Process:

   • After submission, the MDA will begin the review process, which typically takes 3 to 6 months, depending on the complexity of the device and the quality of the submission. Here’s what the review process includes:

Review Process Steps

1. Preliminary Evaluation:

   • The MDA will perform a preliminary review of the application to ensure all required documents and information are included and comply with the submission guidelines.
   • Incomplete applications or missing documents can result in delays, as the MDA will request additional information through the MeDC@St system.

2. Technical Documentation Review:

   • The MDA will conduct an in-depth review of the technical file, including:
     • Device Description: Assessment of the intended use, functionality, and features of the device.
     • Safety and Risk Management: Review of the risk management plan in accordance with ISO 14971 and safety tests (e.g., biocompatibility, electrical safety for applicable devices).
     • Clinical Evidence: The MDA will evaluate the clinical evaluation report or clinical evidence demonstrating the safety and efficacy of the device. Class B devices may require clinical data based on prior studies or performance in other countries.
     • Labeling and Instructions for Use (IFU): Review of the labeling to ensure compliance with MDA guidelines and that the information provided to users is clear and comprehensive.

3. Quality Management System (QMS) Assessment:

   • The MDA will assess whether the manufacturer complies with ISO 13485 or equivalent Quality Management System (QMS) standards, which cover manufacturing processes and procedures to ensure consistent device quality.
   • If the device is manufactured abroad, the QMS of the foreign manufacturing site will be reviewed to ensure it aligns with the required standards.

4. Requests for Additional Information:

   • If there are gaps in the application, such as unclear data, insufficient clinical evidence, or missing documentation, the MDA will issue a request for additional information or clarification.
   • Applicants will need to respond within the specified timeframe (typically 30 days), and delays in providing responses can prolong the review process.

5. Final Evaluation and Decision:

   • Once all technical documentation has been reviewed and any requested clarifications or additional information have been provided, the MDA will make a final decision on whether to approve or reject the registration.
   • Upon approval, the MDA will issue a Certificate of Registration, and the device will be listed on the Medical Device Register (MDAR). This certificate is typically valid for 5 years.

Post-Approval Considerations

• Post-Market Surveillance: After registration, you are required to comply with post-market obligations such as reporting adverse events, maintaining vigilance records, and conducting periodic reviews of the device's safety and efficacy.
• Re-Registration: The device must be re-registered every 5 years, following a similar process, to remain legally available in the market.

Potential Delays in Registration

Several factors can extend the registration timeline:

• Incomplete Documentation: Missing or insufficient documentation can lead to requests for additional information and delay the review process.
• Clarifications Required by MDA: If the MDA finds discrepancies or requires further clarification, this can add time to the process.
• Complexity of the Device: More complex devices or those with novel features may require a more in-depth evaluation, leading to longer review times.
• Clinical Data Requirements: If local clinical studies are required, it may take additional time to gather the necessary clinical evidence for submission.