Device Classification Confirmation: Ensure your device falls under Class B, which is low-to-moderate risk according to MDA’s classification rules.

Register for an account if you do not already have one. This account is necessary to initiate and track the registration process.

Registration Fees: The fees for Class B IVD device registration typically range from approximately MYR 2,500 to MYR 5,000 (USD 500 to USD 1,000). The exact cost can vary based on the device type, application specifics, and potential additional assessments. MDA periodically updates its fee schedule, so it’s best to consult their latest fee structure or reach out directly for accurate information.

Confirm that the IVD device is classified as Class B, which generally indicates a low to moderate risk. The classification depends on the intended use, risk level, and degree of invasiveness of the device. If you’re uncertain, MDA guidelines or a regulatory expert can provide guidance.

Verify that your IVD device qualifies as a Class B device, which is defined as a low to moderate-risk IVD device. The MDA classification system is based on intended use, potential risk, and degree of invasiveness. If unsure, consult MDA guidelines or seek assistance from a regulatory consultant.

B-class in vitro diagnostic (IVD) medical device registration with Malaysia’s Medical Device Authority (MDA) refers to the process of registering moderate-risk in vitro diagnostic devices, which fall under Class B according to Malaysian regulatory standards. These devices typically include tests or diagnostic tools with moderate potential risk but are not high-risk devices (like Class C or D).

Determine Device Classification: Confirm that your device falls under Class B as per the Medical Device Act 2012 and its regulations. Class B devices are typically low to moderate risk.

This phase involves gathering all necessary documentation, conducting performance testing, and establishing a compliant Quality Management System (QMS).