The time required to obtain D-class medical device registration in Malaysia can vary depending on several factors, including the complexity of the device, the completeness of the application, and the efficiency of the submission process. However, a general estimate for the entire registration process is as follows:

1. Pre-Registration Preparation

Duration: 3-6 Months

• Quality Management System (QMS): Establishing and maintaining an ISO 13485-compliant QMS.
• Technical Documentation: Preparing comprehensive technical documentation, including clinical data, risk management reports, and performance testing results.
• Authorized Representative (AR): Appointing a Malaysian Authorized Representative if applicable.
• Conformity Assessment Preparation: Engaging a Conformity Assessment Body (CAB) and preparing for the assessment.

2. Conformity Assessment

Duration: 2-4 Months

• CAB Engagement: Choosing and engaging a CAB accredited by the MDA.
• Assessment Process: The CAB reviews the technical documentation and conducts necessary evaluations or audits.

3. Submission of Application

Duration: 1-2 Weeks

• Prepare and Submit Application: Completing the application form on the MeDC@St system, uploading all required documents, and paying the registration fees.

4. MDA Review Process

Initial Review: 1-2 Months

• Initial Assessment: The MDA reviews the application and technical documentation.
• Additional Information Requests: The MDA may request additional information or clarifications. Response time can vary but typically takes around 1-2 weeks.

Final Review and Approval: 1-2 Months

• Evaluation and Decision: After receiving all necessary information, the MDA completes the final review and issues the Certificate of Registration if the application is successful.

5. Total Estimated Time

Overall Duration: 6-12 Months

• Pre-Registration Preparation: 3-6 months
• Conformity Assessment: 2-4 months
• Submission of Application: 1-2 weeks
• MDA Review: 2-4 months (including initial review and final approval)

Factors Affecting Timeframe

• Complexity of the Device: More complex devices may require longer assessment times.
• Completeness of Documentation: Incomplete or unclear documentation can lead to delays.
• Response Time: Prompt responses to additional information requests can expedite the process.
• CAB Availability: The availability and workload of the Conformity Assessment Body can impact timing.