After applying for and receiving approval for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, you must comply with several ongoing regulatory requirements and obligations to maintain compliance with Health Canada's regulations.

Before applying for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, there are several key preparatory steps to ensure that the application process goes smoothly and that your device complies with Health Canada's regulatory requirements.

After the Class I in vitro diagnostic (IVD) medical device MDL registration is approved in Canada, manufacturers and distributors need to adhere to several post-market obligations and ongoing responsibilities to ensure compliance with Health Canada's regulations and maintain the device's market authorization.

For Class I in vitro diagnostic (IVD) medical devices seeking MDL registration in Canada, the device must meet the standards set out in Health Canada's Medical Device Regulations (MDR) and any applicable international standards. These standards ensure the safety, effectiveness, and quality of the device before it can be marketed in Canada.

For the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, the required technical documentation primarily ensures that your device complies with Health Canada's Medical Device Regulations (MDR). This documentation provides Health Canada with the necessary information to evaluate the safety, effectiveness, and quality of the device.

The application timeline for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada can vary depending on several factors, including the completeness of the application and Health Canada’s processing times.

To apply for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, certain conditions and requirements must be met to ensure compliance with Health Canada’s Medical Device Regulations (MDR).

The application for the Medical Device Establishment License (MDEL) for a Class I IVD device must be submitted to Health Canada. You will apply through the Health Canada Medical Device Licensing System (MDLS), which is part of the Electronic Submission System (ESS).