The processing cycle for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada typically involves several stages, from preparation to approval.

The device must be classified as a Class II IVD according to Health Canada’s classification criteria. This classification typically applies to moderate-risk devices that require a higher level of scrutiny than Class I devices but less than Class III and IV devices.

To apply for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, you will need to follow specific steps and utilize the appropriate resources.

Form 3011 is the official application form for an MDL. It gathers key information about the device, its intended use, and the applicant.

To register a Class II in vitro diagnostic (IVD) medical device for a Medical Device License (MDL) in Canada, you’ll need to follow Health Canada’s specific procedures, compile required materials, and keep key regulatory considerations in mind.

To register for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) in Canada, you will need to navigate through the Health Canada regulatory framework.

Application Fee for Class II MDL: The application fee for a Class II MDL is typically less than for higher-risk Class III and IV devices. As of recent guidance, Class II application fees are around CAD $5,000 to CAD $6,000, but these can vary.

To process Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, manufacturers must meet Health Canada's requirements to ensure the device’s safety, quality, and effectiveness.