The duration for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA) typically ranges from 30 to 90 days after submission, assuming all required documents are complete and no additional information is needed.

Factors Affecting the Registration Duration

1. Completeness of Application: If all required documentation is submitted accurately, the review may proceed faster. Missing or incomplete documents can lead to delays.
2. Technical Review and Evaluation: MDA may need additional time for complex devices that require in-depth review of technical data and clinical performance evidence.
3. Request for Additional Information: If MDA requests clarifications or extra documents, the time to respond can extend the process.
4. Manufacturing Site Inspection (if applicable): For some devices, MDA may require an inspection of the manufacturing site, adding to the review time.

Summary of Typical Timeline

• 30 to 90 days for standard review and approval.
• Additional time may be necessary if clarifications, further documents, or an inspection are required.

Preparation of a complete and compliant application can help reduce the registration timeline, ensuring a smoother process through MDA.

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