Under Malaysia's regulatory framework, IVD devices are classified into risk-based categories (A, B, C, and D) depending on the potential risk they pose to patients and users. B-class IVD devices are considered low-to-moderate risk. They are typically more complex than A-class (lowest risk) devices but present fewer risks than higher classes like C and D. Examples of B-class IVD devices may include certain reagents, calibrators, and control materials used in medical laboratories for diagnostic testing.

Device Classification: Confirm that your device qualifies as a B-class IVD device based on MDA's classification guidelines for IVDs.

Device Classification Verification: Ensure that the device is classified as B-class according to MDA’s classification guidelines for IVD medical devices.

Confirm that your device qualifies as a B-class IVD according to the MDA classification criteria. This can involve consulting MDA's classification guidelines.

The duration for applying for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA) can vary based on several factors, including the completeness of the application, the complexity of the device, and the current workload of the MDA.

Device Classification: Confirm that the device is classified as a B-class IVD based on MDA classification criteria.

Quality Management Systems: This standard emphasizes the importance of a robust quality management system (QMS) that includes processes for handling changes, corrective actions, and continuous improvement. Regular updates to the QMS must reflect any changes to the device or manufacturing processes.

After applying for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), manufacturers must adhere to several regulations and requirements to ensure compliance throughout the registration process and after obtaining approval.