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Medical Device License Agreement Template for Singapore

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Key Requirements PROMPT example:

Medical Device License Agreement

"I need a Medical Device License Agreement for licensing our new cardiac monitoring device to a Singapore-based distributor, with exclusive rights for Southeast Asia and including provisions for technical training and maintenance support, targeted for implementation in March 2025."

What is a Medical Device License Agreement?

The Medical Device License Agreement is a crucial document used when granting rights to manufacture, distribute, or sell medical devices in Singapore. This agreement type is specifically designed to comply with Singapore's strict regulatory framework, including HSA requirements and the Health Products Act. It addresses key aspects such as product registration, quality standards, safety requirements, and regulatory compliance while protecting both parties' interests. The agreement is particularly important given Singapore's position as a major healthcare hub in Asia and its stringent medical device regulations.

What sections should be included in a Medical Device License Agreement?

1. Parties: Identification of licensor and licensee, including full legal names and registered addresses

2. Background: Context of the agreement, including brief description of the medical device and purpose of licensing

3. Definitions: Key terms used throughout the agreement, including technical and regulatory terminology

4. Grant of License: Scope and nature of the license being granted, including territory and exclusivity terms

5. Regulatory Compliance: Obligations regarding HSA compliance, registrations, and maintaining regulatory approvals

6. Quality Control: Standards and procedures for maintaining product quality and safety

7. Financial Terms: Payment terms, royalties, and other financial obligations

8. Term and Termination: Duration of agreement and circumstances for termination

9. Intellectual Property: IP ownership, rights, and protection measures

What sections are optional to include in a Medical Device License Agreement?

1. Manufacturing Rights: Terms and conditions for manufacturing rights of the medical device, including quality control standards and compliance requirements

2. Distribution Rights: Specific terms for distribution channels and territories, including requirements for maintaining distribution networks

3. Training and Support: Terms for technical training and ongoing support, including maintenance and troubleshooting procedures

4. Clinical Trials: Requirements and procedures for clinical trials, including compliance with local regulatory requirements

What schedules should be included in a Medical Device License Agreement?

1. Product Specifications: Detailed technical specifications of the medical device

2. Quality Standards: Specific quality control requirements and standards

3. Regulatory Approvals: List of required regulatory approvals and certificates

4. Territory Schedule: Detailed description of licensed territories

5. Payment Schedule: Detailed breakdown of financial terms and payment structures

6. Technical Documentation: Required technical and maintenance documentation

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok成人版 | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

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Industries

Health Products Act (Chapter 122D): Primary legislation governing medical devices in Singapore, establishing regulatory framework for health products including medical devices

Health Products (Medical Devices) Regulations 2010: Specific regulations detailing requirements for medical device registration, licensing, and compliance in Singapore

Health Products (Licensing of Retail Pharmacies) Regulations: Regulations governing the retail distribution and sale of medical devices through pharmacies

ISO 13485: International standard for medical devices quality management systems that must be considered in licensing agreements

Good Distribution Practice for Medical Devices (GDPMDS): Guidelines ensuring proper distribution practices for medical devices in Singapore

Patents Act (Chapter 221): Legislation protecting intellectual property rights related to medical device innovations and technology

Trade Marks Act (Chapter 332): Law governing trademark protection for medical device branding and intellectual property

Copyright Act (Chapter 63): Legislation protecting copyright aspects of medical device documentation, software, and related materials

Contract Law (Chapter 53): General contract law principles governing the formation and enforcement of license agreements in Singapore

Sale of Goods Act (Chapter 393): Law governing commercial transactions and sales aspects of medical devices

Competition Act (Chapter 50B): Legislation ensuring fair competition and preventing anti-competitive practices in medical device licensing

Personal Data Protection Act 2012 (PDPA): Law governing the collection, use, and disclosure of personal data in medical device operations

ASEAN Medical Device Directive (AMDD): Regional framework harmonizing medical device regulations across ASEAN member states

Consumer Protection (Fair Trading) Act: Legislation protecting consumer interests in medical device transactions and usage

GN-23: Guidance on Medical Device Software: HSA guidelines specific to software components of medical devices

Singapore Medical Device Registration (SMDR) guidelines: Regulatory guidelines for registering medical devices with the Health Sciences Authority

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