The fee for a Class III MDL application is typically in the range of CAD 12,000 to CAD 20,000, depending on the specifics of the application and any additional services required.

Ensure your device is correctly classified as Class III based on Health Canada’s classification rules.

Determine Classification: Confirm that your device is classified as Class III according to Health Canada’s classification rules.

Regulatory Oversight: Class III IVDs are subject to strict regulatory controls due to their potential impact on patient health.

Determine Classification: Confirm that your device is classified as Class III. This usually involves a risk assessment based on Health Canada’s classification rules.

The time it takes to obtain MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong can vary based on several factors, including the complexity of the device, the completeness of the application, and the efficiency of the review process.

Yes, there is an annual review process for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong.

Legal Authorization: MDACS registration provides legal authorization to market and sell the device in Hong Kong, opening up opportunities for manufacturers to access a valuable healthcare market.