The Medical Device License Agreement is a critical legal instrument used in the Canadian healthcare and medical device industry when one party wishes to grant another party the rights to use, distribute, or manufacture specific medical devices. This agreement ensures compliance with Canadian regulatory requirements, particularly the Medical Devices Regulations (SOR/98-282) and Health Canada guidelines. It's essential when medical device manufacturers want to expand their market reach through licensing arrangements, when healthcare institutions need to secure rights to use specific technologies, or when distributors require legal authorization to sell medical devices. The agreement includes comprehensive provisions for quality control, safety standards, regulatory compliance, and risk management, all tailored to meet Canadian federal and provincial legal requirements.
Your data doesn't train Genie's AI
You keep IP ownership of your information
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
OR
Let Ƶ's market-leading legal AI identify missing terms, unusual language, compliance issues and more - in just seconds.
1. Parties: Identification of the licensor and licensee, including full legal names and addresses
2. Background: Context of the agreement, including brief description of the medical device and regulatory status
3. Definitions: Detailed definitions of technical terms, regulatory references, and key concepts used in the agreement
4. Grant of License: Scope of the license granted, including territory, exclusivity, and permitted uses
5. Regulatory Compliance: Obligations regarding Medical Device Regulations and Health Canada requirements
6. Quality Control and Safety: Standards for device quality, safety requirements, and testing protocols
7. Financial Terms: License fees, royalties, payment terms, and reporting requirements
8. Intellectual Property Rights: IP ownership, protection, and enforcement provisions
9. Representations and Warranties: Parties' assurances regarding device safety, regulatory compliance, and IP rights
10. Liability and Indemnification: Risk allocation, liability limitations, and indemnification obligations
11. Term and Termination: Duration of agreement, renewal terms, and termination rights
12. Post-Termination Obligations: Obligations surviving termination and wind-down procedures
13. Confidentiality: Protection of confidential information and trade secrets
14. General Provisions: Standard legal provisions including governing law, dispute resolution, and amendments
1. Manufacturing Rights: Include when licensee has rights to manufacture the device
2. Distribution Rights: Include when agreement covers distribution rights
3. Training and Support: Include when licensor provides technical training or ongoing support
4. Data Protection: Include when agreement involves handling of patient or sensitive data
5. Sub-licensing Rights: Include when licensee is permitted to sub-license
6. Import/Export Provisions: Include for international distribution arrangements
7. Marketing and Promotion: Include when agreement covers marketing rights
8. Field of Use Restrictions: Include when license is limited to specific medical applications
1. Schedule A - Device Specifications: Detailed technical specifications of the medical device
2. Schedule B - Quality Standards: Required quality control measures and standards
3. Schedule C - Regulatory Approvals: List of obtained and required regulatory approvals
4. Schedule D - Financial Terms: Detailed breakdown of fees, royalties, and payment terms
5. Schedule E - Territory Definition: Detailed description of licensed territory
6. Schedule F - Training Requirements: Training protocols and requirements
7. Appendix 1 - Reporting Templates: Standard forms for required regulatory and financial reporting
8. Appendix 2 - Safety Procedures: Safety protocols and incident reporting procedures
Authors
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Medical Devices
Biotechnology
Healthcare Technology
Pharmaceutical
Research & Development
Medical Equipment Manufacturing
Healthcare Services
Medical Distribution
Relevant Teams
Legal
Regulatory Affairs
Quality Assurance
Compliance
Product Development
Sales
Risk Management
Procurement
Operations
Business Development
Research & Development
Medical Affairs
Relevant Roles
Legal Counsel
Regulatory Affairs Manager
Medical Device Quality Manager
Compliance Officer
Healthcare Technology Director
Product Development Manager
Medical Device Sales Director
Risk Management Officer
Medical Device Safety Officer
Procurement Manager
Healthcare Operations Director
Medical Technology Officer
Contract Manager
Business Development Director
Medical Device Specialist
Find the exact document you need
Beta License Agreement
A Canadian-law governed agreement for pre-release software testing, defining terms for beta access, feedback, and liability.
find out more
Boilerplate EULA
A Canadian-law compliant End User License Agreement setting terms and conditions for software use, including license grants, restrictions, and legal protections.
find out more
Model License Agreement
A standardized Canadian license agreement template for intellectual property and technology transfers, compliant with federal and provincial requirements.
find out more
Business License Agreement
A Canadian-law governed agreement granting rights to operate a business using the licensor's intellectual property and business system.
find out more
Technical License Agreement
A Canadian-law governed agreement for licensing technical intellectual property, including terms for usage, maintenance, and compliance requirements.
find out more
Open Source EULA
Canadian-compliant Open Source EULA establishing terms for software distribution and use under Canadian federal and provincial laws.
find out more
Authorized User Agreement
A Canadian-law governed agreement defining terms and conditions for authorized access to systems or services, ensuring compliance with federal and provincial regulations.
find out more
Online User Agreement
A Canadian-law governed agreement setting out terms and conditions for users of online services, ensuring compliance with federal and provincial requirements.
find out more
As Is License Agreement
A Canadian-law governed agreement for licensing materials 'as is' without warranties, transferring usage rights while protecting the licensor through explicit disclaimers.
find out more
Basic License Agreement
A Canadian-law governed agreement establishing terms for licensing intellectual property or proprietary assets between a licensor and licensee.
find out more
Trademark License Agreement Between Parent And Subsidiary
A Canadian law-governed agreement establishing trademark licensing terms between a parent company and its subsidiary, ensuring proper intellectual property management and compliance with Canadian regulations.
find out more
Medical Device License Agreement
Canadian-law governed agreement for medical device licensing, compliant with federal and provincial healthcare regulations.
find out more
Venue License Agreement
A Canadian legal agreement establishing temporary usage rights for a venue, including terms, conditions, and regulatory compliance requirements.
find out more
End User Service Agreement
A Canadian-law governed agreement defining terms and conditions for end users accessing digital services, ensuring compliance with federal and provincial regulations.
find out more
Basic EULA
A Canadian-law governed End User License Agreement defining software usage terms and conditions between provider and user, compliant with Canadian federal and provincial regulations.
find out more
Reseller License Agreement
A Canadian-law governed agreement establishing terms for product/service resale rights, including licensing, distribution, and commercial terms.
find out more
Non Exclusive Software License Agreement
A Canadian-law governed agreement granting non-exclusive rights to use software, defining usage terms, fees, and obligations between licensor and licensee.
find out more
Commercial Software License Agreement
A Canadian-law governed agreement establishing terms and conditions for commercial software licensing, including usage rights, restrictions, and compliance requirements.
find out more
Terms Of Use EULA
Canadian-law governed Terms of Use/EULA defining rights and obligations for software or digital service usage, ensuring compliance with federal and provincial regulations.
find out more
Limited Copyright License Agreement
A Canadian legal agreement that grants specific, limited rights to use copyrighted material while maintaining the original owner's copyright under Canadian law.
find out more
Retail License Agreement
A Canadian-law governed agreement establishing retail licensing rights and obligations between a brand owner and retailer.
find out more
Network User Agreement
A Canadian-law governed agreement establishing terms and conditions for network access and usage, ensuring compliance with federal and provincial regulations.
find out more
Digital License Agreement
A Canadian-law governed agreement establishing terms for digital product licensing, compliant with federal and provincial regulations.
find out more
Trial License Agreement
A Canadian-law agreement governing the temporary license of software or technology for evaluation purposes, including trial terms and IP protection.
find out more
Limited Use License Agreement
A Canadian-law governed agreement that sets out restricted terms for using licensed intellectual property, software, or content, with specific usage limitations and protections.
find out more
White Label Software License Agreement
A Canadian-law governed agreement enabling software rebranding and distribution rights between a software provider and a white label partner.
find out more
Application License Agreement
A Canadian-law governed agreement establishing terms for software licensing, usage, and distribution, incorporating federal and provincial requirements for software licensing and digital services.
find out more
Use License Agreement
A Canadian-law governed agreement establishing terms for licensed use of intellectual property, software, or other proprietary assets.
find out more
Subscription License Agreement
Canadian-law governed agreement for subscription-based access to software, content, or services, suitable for both B2B and B2C relationships.
find out more
Single User License Agreement
A Canadian law-governed agreement defining terms and conditions for individual software use, including license scope, restrictions, and user rights.
find out more
Single Use License Agreement
A Canadian law-governed agreement granting one-time or limited use rights to intellectual property, content, or technology, with specific usage terms and restrictions.
find out more
Service Use Agreement
Canadian-law governed agreement establishing terms and conditions for service provision, ensuring compliance with federal and provincial regulations.
find out more
Media License Agreement
A Canadian-law governed agreement establishing terms for media content licensing, including usage rights, territorial restrictions, and regulatory compliance.
find out more
Freeware EULA
Canadian-compliant End User License Agreement for free software distribution, addressing usage rights, privacy, and liability under Canadian law.
find out more
Exclusive Software License Agreement
A Canadian-law governed agreement granting exclusive rights to use and distribute software, with comprehensive terms for licensing, maintenance, and IP protection.
find out more
Evaluation License Agreement
A Canadian-law governed agreement allowing temporary access to proprietary technology or software for evaluation purposes.
find out more
Copyright License Agreement For Written Work
A Canadian-law governed agreement that licenses rights to written work from a copyright holder to a licensee, establishing usage terms and protecting both parties' interests.
find out more
Storage Licence Agreement
A Canadian legal agreement establishing terms for storage space usage between a facility operator and customer, incorporating federal and provincial requirements.
find out more
Service User Agreement
A Canadian-law governed agreement defining terms and conditions for service provision between service providers and users, incorporating federal and provincial legal requirements.
find out more
Master Use License Agreement
A Canadian-law governed agreement establishing terms for licensed use of proprietary material between a licensor and licensee.
find out more
ұԾ’s Security Promise
Genie is the safest place to draft. Here’s how we prioritise your privacy and security.
Your documents are private:
We do not train on your data; ұԾ’s AI improves independently
All data stored on Genie is private to your organisation
Your documents are protected:
Your documents are protected by ultra-secure 256-bit encryption
We are ISO27001 certified, so your data is secure
Organizational security:
You retain IP ownership of your documents and their information
You have full control over your data and who gets to see it
.png)