When applying for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, you will need to prepare a set of materials and documents that demonstrate compliance with Health Canada's Medical Device Regulations (MDR). Here’s an outline of the required materials and how to prepare the application documents.

The process for applying for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada involves several key steps. Below is an overview of the process, the required materials, and the key points to keep in mind when applying for the Medical Device Establishment License (MDEL) for a Class I IVD device.

In Canada, the application for Class I in vitro diagnostic (IVD) medical device registration (via a Medical Device Establishment License (MDEL)) should be submitted to Health Canada, the federal department responsible for the regulation of medical devices.

Initial Application Fee: Health Canada charges a fee for processing an MDEL application. The cost depends on the type and size of the establishment, but as of 2024, the application fee for MDEL is typically in the range of CAD $5,000 to CAD $10,000.

To apply for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, the device must comply with Health Canada's Medical Device Regulations (MDR).

To register a Class I in vitro diagnostic (IVD) medical device in Canada, you need to follow the steps outlined by Health Canada’s Medical Device Regulations (MDR). Since Class I IVD devices are considered low-risk, the registration process is relatively simple and involves the Medical Device Establishment License (MDEL) and self-declaration of conformity.

The Class I in vitro diagnostic (IVD) medical device MDL registration in Canada refers to the Medical Device License (MDL) that is required for legally selling or distributing medical devices, including in vitro diagnostic (IVD) devices, within Canada. For Class I devices, the registration process is relatively straightforward compared to higher-class devices but still requires compliance with Canada's Medical Device Regulations (MDR).

Class I in vitro diagnostic devices are low-risk devices, but you must verify that your device is correctly classified under the Canadian regulations. You can refer to the Medical Device Regulations (MDR) for this classification.