The cycle for registering a D-class medical device in Malaysia typically involves several stages and can span a significant amount of time due to the high-risk nature of these devices. Here’s a breakdown of the typical timeframes for each stage in the registration process:

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 files, including device specifications, risk management reports, clinical evaluations, and performance testing results.
• Authorized Representative (AR): Appointing a Malaysian AR 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: Selecting and engaging a CAB accredited by the MDA.
• Assessment Process: The CAB reviews the technical documentation, conducts necessary evaluations, and provides a conformity assessment report.

3. Submission of Application

Duration: 1-2 Weeks

• Prepare and Submit Application: Complete the application form on the MeDC@St system, upload all required documents, and pay the applicable 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, which can extend the review period. Response time can vary but typically is 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. Post-Registration Activities

Ongoing

• Post-Market Surveillance (PMS): Continuous monitoring of the device’s performance and reporting of adverse events.
• Field Safety Corrective Actions (FSCA): Management of any safety issues that arise.
• Renewal: Apply for renewal at least 6 months before the registration expires. The renewal process may take several months.

Summary of Time Cycle

1. Pre-Registration Preparation: 3-6 Months
2. Conformity Assessment: 2-4 Months
3. Submission of Application: 1-2 Weeks
4. MDA Review:
   • Initial Review: 1-2 Months
   • Final Review and Approval: 1-2 Months

Total Estimated Time

• Overall Cycle: The entire process from preparation to receiving the registration certificate can typically take 6 to 12 months, depending on the complexity of the device, the efficiency of document preparation, and any additional information requests or delays.

Contact Us：

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