Health Canada medical device licensing
Advice on device classification and licence applications, plus establishment licensing and advertising rules.
What is included
- Explains the licensing path for your product or activity
- Prepares or reviews applications and supporting documents
- Reviews labels, advertising and claims for compliance
- Drafts or negotiates clinical trial agreements
- Responds to Health Canada inspections or questions
What is not included
- Independent reports and other disbursements
- Appeals or judicial review unless added to the retainer
- Clinical, billing or management consulting
Who this service is for
- Medical device and natural health product companies
- Cannabis licence holders and applicants
- Hospitals, sponsors and researchers running clinical trials
Information to have ready
- 1Product details, formulation or device description
- 2Draft labels, claims and marketing materials
- 3Quality and safety documents
- 4Draft agreements or Health Canada correspondence
How a referral works
- 1Tell us in a few words what the matter is about, and who else is involved, so we can check for a conflict of interest.
- 2We recommend an Ontario lawyer for your matter, and at least one other you could choose instead.
- 3The lawyer runs their own conflict check, confirms the scope and quotes the fee, normally in a written retainer agreement.
- 4You pay the lawyer's fee to the lawyer. Any referral fee comes out of it, is disclosed to you in writing, and never increases what you pay.
NEO Legal Services Professional Corporation is a licensed paralegal firm, not a law firm. Every step of a referral, and your rights
Frequently asked questions
What does the lawyer charge?
A typical Ontario fee for this service is $3,000–$9,000, plus HST. The lawyer quotes the actual fee before any work starts. You pay the lawyer directly; the referral itself costs you nothing.
Can a product be sold while an application is pending?
Usually not. Many health products need a licence or product number before they are sold, so the lawyer will confirm what applies before launch.
Are health claims in advertising regulated?
Yes. Claims about health products are closely regulated and generally must match what the product is authorized for.
General information only, not legal advice. NEO Legal Services Professional Corporation is a licensed paralegal firm regulated by the Law Society of Ontario.
Important limitations
- No outcome can be guaranteed
- Regulators' deadlines must be met even while a lawyer is being chosen
- The lawyer confirms the scope, fee and steps in a written retainer before starting
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