Regulatory Consulting

In order to legally market health products in Canada, manufacturers, private labelers, importers, and distributors must comply with the governing Canadian laws.

Health Canada, through the Therapeutic Products Directorate and Medical Devices Bureau, is the federal regulatory authority that is responsible for the sale of medical devices and drugs in Canada.

Our team has a thorough understanding of these regulations and will work closely with you to ensure that your go-to-market process is as smooth as possible.

Whether you are launching a pharmaceutical, a natural health product, or a medical device, RT Medical will help guide you through Health Canada’s process.

Lead and execute new product trials 

Product trials are conducted in order to validate the legitimacy of a new product idea before moving forward with a launch.

Your product will be placed in a trial marketplace and where it is delivered to potential customers in order to see how it performs in certain market conditions. Our team will help with this entire process!

Register your medical device 

In Canada, marketing a medical device requires either a Medical Device Establishment License (MDEL), or a Medical Device License (MDL), depending on where your device is classed.

Applications must be in full compliance with the Canadian Medical Devices Regulations, and will need to be submitted to Health Canada alongside other supplemental documentation.

Obtain a Natural Product Number (NPN) 

A Natural Product Number is an eight-digit number assigned to each and every natural health product that has been approved to be marketed under the Natural Health Product Regulations.

In order to obtain a natural product number, the Natural and Non-Prescription Health Product Directorate (NNHPD) of Health Canada must review and assess all product details before passing approval.

Obtain a Drug Identification Number (DIN) for drugs and biologics 

A Drug Identification Number is an eight-digit number that needs to be assigned to a drug/biologic product before it can be legally marketed in the U.S and Canada.

This number is used to uniquely identify all drug products sold in Canada, and certify that they have passed a formal review of the formula, product labeling and instructions for use.

Determine and obtain a regulator agreement for the regulatory pathway that applies to your specific product

Depending on what kind of product you are looking to have approved for distribution, there are different regulatory pathways and agreements that must be completed.

Regulatory pathways are administrative processes by which products are authorized to be imported into a country in which they would otherwise be unavailable.

We help determine and obtain a regulator agreement for the pathway that correlates with your specific product or device.