The time frame for applying for Class A medical device MDA registration in Malaysia can vary, but here’s a general outline of the time involved at each stage of the process:

1. Pre-Registration Preparation (Varies)

• Time Frame: This stage can take from several weeks to a few months, depending on how quickly you can gather the required documents and ensure that your device complies with the necessary standards and regulations.
• Preparation Tasks:
  • Ensure that your device complies with relevant international standards (e.g., ISO 13485, ISO 14971).
  • Prepare the technical documentation, labeling, and risk management files.
  • Set up an account in the Medical Device Registration System (MDRS) if you haven't done so.

2. Submission of Application (1–2 Weeks)

• Time Frame: Once you have completed your documentation, you can submit your application on the MDA’s online registration platform (MDRS). The submission process itself is relatively quick, taking 1 to 2 weeks to prepare and submit the application, depending on the completeness of your documents.
  • Ensure that the payment for the registration fee is made when submitting the application.

3. MDA Review Process (4 to 8 Weeks)

The MDA’s review process involves several stages, which typically take around 4 to 8 weeks for Class A devices. However, this can vary depending on factors like the complexity of the device, the completeness of your documentation, and the MDA’s workload. Below are the stages involved in the MDA review process:

a. Initial Application Review (1–2 Weeks)

• The MDA first reviews the completeness of your application and documentation.
  • Documents Check: This includes verifying that all required documents are submitted, such as technical documentation, ISO certifications, labeling, and declarations of conformity.
  • Registration Fee: Ensure that the registration fee is paid.

b. Evaluation of Technical Documentation (2–4 Weeks)

• The MDA evaluates the technical documentation to ensure the device complies with Malaysian regulations and international standards.
  • Risk Management: The MDA will assess the device’s risk management file to ensure that it meets the requirements of ISO 14971.
  • Performance and Safety: The MDA will review any test reports (performance, safety, and clinical data, if applicable) to ensure the device is safe and performs as intended.
  • Quality Management System (QMS): If the device manufacturer has an ISO 13485 certification, it will be reviewed to ensure the manufacturer has a quality management system in place.

c. Decision Making (1–2 Weeks)

• Once the technical documentation is reviewed, the MDA will make a decision on whether to approve the registration. If the device meets all requirements, the registration certificate will be issued.
  • If additional clarification or documents are needed, the MDA will request them, which could lead to delays.

d. Approval and Issuance of Registration Certificate (1–2 Weeks)

• If the device passes the review, the MDA will issue the Medical Device Registration Certificate.
  • Registration Duration: The registration is typically valid for 5 years from the date of issuance.

4. Post-Approval (Ongoing)

• Post-Market Surveillance: After registration, manufacturers are required to conduct post-market surveillance to monitor the device’s performance in the market. If there are any changes to the device (e.g., labeling, design, or manufacturing), these must be reported to the MDA for review.

Summary of Time Frames for Each Stage:

1. Pre-Registration Preparation: Several weeks to months (depends on readiness).
2. Application Submission: 1–2 weeks.
3. MDA Review Process:
   • Initial Application Review: 1–2 weeks.
   • Evaluation of Technical Documentation: 2–4 weeks.
   • Decision Making: 1–2 weeks.
   • Approval and Issuance of Certificate: 1–2 weeks.

Total Estimated Time for Class A Medical Device Registration:

The entire process can take anywhere from 8 weeks to 12 weeks (approximately 2 to 3 months) from the time of application submission to receiving the approval and registration certificate, assuming that all documentation is in order and no major issues arise.

However, if additional documentation or clarifications are needed, the process may take longer. Therefore, it is advisable to plan ahead and allow sufficient time for the review and approval process.

Contact Us：

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