The time cycle for applying for D-class medical device registration in Malaysia involves several stages, each with its own timeframe. Here’s an overview of the typical time cycle and stages of the review process:

1. Pre-Registration Preparation

Preparation Time:

• Typically 3-6 Months: This stage involves gathering and preparing all necessary documentation, including technical files, quality management system (QMS) documentation, clinical evaluations, and risk management reports.

2. Submission of Application

Submission Time:

• Application Preparation: 1-2 weeks to compile and complete the application form and upload all required documents to the MeDC@St system.

3. Conformity Assessment

Engage Conformity Assessment Body (CAB):

• Assessment Time: 2-4 weeks to select and engage a CAB. The CAB will review the documentation and may conduct audits or assessments as necessary.

CAB Evaluation:

• Evaluation Time: 2-3 months. The CAB assesses the technical documentation and conducts any required evaluations or audits.

4. Application Review by MDA

Initial Review:

• Initial Assessment Time: 1-2 months. The MDA reviews the submitted application and technical documentation.

Additional Information Request:

• Response Time: Varies. If additional information is requested by the MDA, the manufacturer typically has 1-2 weeks to respond. The time to address these requests can extend the overall review period.

5. Issuance of Registration

Approval Time:

• Final Decision: After receiving all necessary information and completing the review, the MDA typically issues a Certificate of Registration within 1-2 months.

6. Post-Registration Requirements

Post-Market Surveillance (Ongoing)

• Continuous: Implement and manage ongoing PMS activities throughout the device’s lifecycle.

Renewal and Updates:

• Renewal Application: Begin renewal application at least 6 months before the registration expires. The renewal process may take several months to complete.

Summary of Time Cycle

1. Pre-Registration Preparation: 3-6 months
2. Submission of Application: 1-2 weeks
3. Conformity Assessment: 2-4 months
4. Application Review by MDA:
   • Initial Review: 1-2 months
   • Additional Information Request: Varies
5. Issuance of Registration: 1-2 months after final review

Stages of the Review Process

1. Pre-Submission

   • Prepare and compile all necessary documentation.
   • Ensure compliance with ISO 13485 and other relevant standards.

2. Submission

   • Submit the application via MeDC@St and pay the required fees.

3. Conformity Assessment

   • CAB reviews documentation and conducts necessary evaluations.
   • Obtain a conformity assessment report.

4. Initial Review by MDA

   • MDA conducts a preliminary review of the application and supporting documents.

5. Additional Information Request (if needed)

   • Address any queries or additional information requests from the MDA.

6. Final Review and Approval

   • MDA completes the final review and issues the Certificate of Registration.

7. Post-Market Surveillance and Compliance

   • Implement PMS and manage post-market requirements.