No, an annual review is generally not required for B-class in vitro diagnostic (IVD) medical devices registered with Malaysia's Medical Device Authority (MDA). However, there are some ongoing obligations that manufacturers must fulfill to maintain compliance:

Ongoing Compliance Requirements for B-Class IVDs

1. Post-Market Surveillance (PMS)

   • Manufacturers must have a post-market surveillance system to monitor the safety and performance of the device after it enters the market. This includes tracking adverse events, complaints, and any field safety corrective actions (FSCAs) that may be necessary.

2. Adverse Event Reporting

   • Any adverse events associated with the device must be reported to MDA within a specified timeframe. This allows MDA to monitor device safety and take appropriate actions if needed.

3. Periodic Quality Audits

   • Although not an official annual review, manufacturers should conduct regular internal audits as part of their Quality Management System (QMS) to ensure ongoing compliance with ISO 13485 and other regulatory requirements.

4. Renewal Every Five Years

   • Registration with MDA for B-class IVDs is typically valid for five years. Manufacturers must apply for renewal before the registration expires to continue legally marketing the device in Malaysia.

Key Points

While there’s no formal annual review requirement, maintaining an effective PMS system, reporting any adverse events, and conducting regular quality audits are crucial for continued compliance. This helps ensure that the device remains safe, effective, and compliant with MDA regulations throughout its lifecycle.

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