The process to obtain B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA) typically takes between 30 and 90 days after submission of a complete application. However, the actual timeline may vary based on several factors.

Timeline Breakdown

1. Application Submission and Initial Review (1–2 weeks)

   • MDA reviews the application for completeness to ensure all required documents are included. Incomplete applications may lead to delays if MDA requests additional documents or clarifications.

2. Technical Evaluation (Up to 90 days)

   • MDA evaluates the device’s technical documentation, including performance and safety data. For straightforward applications with complete data, the review may be faster.
   • If further information is required, MDA will request it, and the applicant’s response time can affect the overall timeline.

3. Manufacturing Site Inspection (if required)

   • For certain devices, MDA may conduct a manufacturing site inspection, which could add several weeks to the process depending on the scheduling and outcome of the inspection.

4. Final Decision and Certificate Issuance

   • Upon a successful review, MDA issues the registration certificate, permitting the device to be legally marketed in Malaysia.

Key Factors Affecting Timeline

• Completeness of Application: Accurate and complete submissions help expedite the process.
• Manufacturer Responsiveness: Prompt replies to MDA requests help avoid delays.
• Device Complexity: Higher-risk devices or those with complex technical evaluations may take longer.

Typical Duration

For a well-prepared application, obtaining B-class IVD registration can take 30 to 90 days from submission to approval.

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