The Medical Device Supply Agreement is essential for organizations engaged in the supply and procurement of medical devices in India. This agreement is particularly relevant given India's evolving regulatory landscape, including the Medical Devices Rules 2017 and recent amendments to healthcare regulations. It is designed to address the complex requirements of medical device transactions, including quality assurance, regulatory compliance, post-market surveillance, and risk management. The agreement is crucial for establishing clear terms for supply, maintenance, training, and support while ensuring compliance with Indian medical device regulations, quality standards, and healthcare safety requirements. It's typically used when establishing long-term supply relationships for medical devices, whether between manufacturers and distributors, or suppliers and healthcare facilities.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Your data doesn't train Genie's AI
You keep IP ownership of your docs
1. Parties: Identification of the supplier and purchaser, including registration details and medical device licenses
2. Background: Context of the agreement, including regulatory framework and purpose
3. Definitions: Definitions of technical terms, regulatory references, and contract-specific terminology
4. Scope of Supply: Detailed description of medical devices to be supplied, including specifications and quantities
5. Term and Renewal: Duration of the agreement and renewal provisions
6. Regulatory Compliance: Compliance with Medical Devices Rules 2017 and other applicable regulations
7. Quality Assurance: Quality standards, testing requirements, and quality management systems
8. Delivery and Acceptance: Delivery terms, inspection procedures, and acceptance criteria
9. Pricing and Payment: Pricing structure, payment terms, and price adjustment mechanisms
10. Warranties: Product warranties, quality guarantees, and regulatory compliance warranties
11. Training and Support: Technical training, maintenance support, and user education requirements
12. Liability and Indemnification: Risk allocation, liability limitations, and indemnification provisions
13. Insurance: Required insurance coverage and minimum insurance limits
14. Confidentiality: Protection of proprietary information and trade secrets
15. Termination: Termination rights, procedures, and consequences
16. Dispute Resolution: Dispute resolution mechanisms and governing law provisions
1. Import/Export Compliance: Required for international supply arrangements, covering customs, duties, and international trade requirements
2. Clinical Support: Needed when the devices require clinical expertise or support during implementation
3. Post-Market Surveillance: Required for high-risk medical devices requiring ongoing monitoring
4. Spare Parts Supply: Relevant for complex medical equipment requiring regular parts replacement
5. Software License: Required when the medical devices include software components
6. Data Protection: Necessary when the devices collect or process patient data
7. Environmental Compliance: Required for devices with specific disposal or environmental impact considerations
8. Exclusive Territory Rights: Optional section for exclusive distribution arrangements
1. Schedule 1 - Product Specifications: Detailed technical specifications of all medical devices covered
2. Schedule 2 - Pricing Schedule: Detailed pricing information, including any volume-based discounts
3. Schedule 3 - Quality Standards: Specific quality requirements and testing protocols
4. Schedule 4 - Service Level Agreement: Performance metrics and service level requirements
5. Schedule 5 - Regulatory Certificates: Copies of required regulatory approvals and certificates
6. Schedule 6 - Training Program: Details of required training programs and materials
7. Schedule 7 - Warranty Terms: Detailed warranty terms and claim procedures
8. Appendix A - Contact Details: Key contact information for both parties
9. Appendix B - Incident Reporting Procedure: Procedures for reporting and handling adverse events
Find the exact document you need
Contract For Supply Of Drinking Water
An Indian law-governed agreement establishing terms and conditions for drinking water supply, including quality standards, delivery terms, and party obligations.
Download
Food Supplier Contract
An Indian law-governed agreement establishing terms for food product supply, incorporating FSSAI and relevant regulatory requirements.
Download
Wood Supply Agreement
An Indian law-governed agreement establishing terms for commercial wood supply, incorporating forestry regulations and commercial requirements.
Download
Vegetable Supply Contract
An Indian law-governed agreement establishing terms for commercial vegetable supply arrangements between suppliers and buyers, incorporating local agricultural and food safety regulations.
Download
Medical Supply Agreement
An India-governed agreement establishing terms for medical supply procurement and delivery, ensuring compliance with local healthcare regulations and quality standards.
Download
Supply Framework Agreement
An Indian law-governed agreement establishing terms for ongoing supply relationships, including ordering, delivery, quality, and payment mechanisms.
Download
Water Supply Service Agreement
An agreement governing water supply services between provider and consumer in India, compliant with state and municipal regulations.
Download
Medical Device Supply Agreement
An Indian law-governed agreement for medical device supply arrangements, incorporating local regulatory requirements and healthcare standards.
Download
Tripartite Agreement For Supply Of Goods
An Indian law-governed agreement establishing terms and conditions between three parties for the supply of goods, defining their respective rights and obligations.
Download
Sand Supply Contract Agreement
An Indian law-governed agreement establishing terms and conditions for commercial sand supply, including quality, delivery, pricing, and regulatory compliance requirements.
Download
Labor Supply Contract
An Indian law-compliant agreement between a principal employer and contractor for the supply and management of contract workers.
Download
Petroleum Product Supply Agreement
An agreement governing the supply of petroleum products in India, establishing terms for quality, delivery, pricing, and regulatory compliance under Indian law.
Download
Manufacturing Supply Agreement
An Indian law-governed agreement between manufacturer and purchaser establishing terms for manufacturing and supply of goods, including quality, delivery, and pricing terms.
Download
Clinical Supply Agreement
An Indian law-governed agreement for the manufacture and supply of pharmaceutical products for clinical trials, incorporating key Indian pharmaceutical regulations and GMP requirements.
Download
Medical Equipment Lease Agreement
An Indian law-governed agreement for leasing medical equipment, establishing terms between equipment providers and healthcare facilities.
Download
Equipment Supply Agreement
An Indian law-governed agreement establishing terms for equipment supply, including specifications, pricing, delivery, and warranties.
Download
Meat Supply Contract
An Indian law-governed agreement establishing terms for commercial meat supply, incorporating FSSAI requirements and regulatory compliance.
Download
Vendor Supply Agreement
An Indian law-governed agreement establishing terms for supply of goods between vendor and purchaser, including delivery, quality, and payment terms.
Download
Module Supply Agreement
An Indian law-governed agreement establishing terms for the supply of modules between supplier and buyer, including quality, delivery, and pricing terms.
Download
Supply And Service Agreement
An Indian law-governed agreement combining supply of goods and provision of services, establishing terms for product delivery and service performance.
Download
Medical Equipment Purchase Agreement
An Indian law-governed agreement for medical equipment purchase, detailing specifications, compliance requirements, and commercial terms.
Download
Raw Material Supply Agreement
An Indian law-governed agreement establishing terms for raw material supply, including quality, delivery, and pricing terms.
Download
Supply Chain Agreement
An Indian law-governed agreement establishing terms and conditions for supply chain relationships, including delivery, quality, and commercial terms.
Download
Sole Supply Agreement
An Indian law-governed agreement establishing exclusive supply arrangements between a supplier and buyer, including terms for product supply, pricing, and quality standards.
Download
Supply Contract Agreement
An Indian law-governed agreement establishing terms and conditions for the supply of goods between parties, including delivery, quality, pricing, and payment terms.
Download
Product Supply Agreement Between Manufacturer And Buyer
An Indian law-governed agreement establishing terms for product supply between manufacturer and buyer, including quality, delivery, and payment terms.
Download
Exclusive Supply Contract
An Indian law-governed agreement establishing exclusive supply arrangements between supplier and buyer, including comprehensive terms for supply, quality, pricing, and territorial exclusivity.
Download
Long Term Supplier Agreement
An Indian law-governed agreement establishing terms for long-term supply relationship between supplier and buyer, including commercial and operational provisions.
Download
Supply And Distribution Agreement
An Indian law-governed agreement establishing terms for product supply and distribution between supplier and distributor, including commercial and operational requirements.
Download
Purchase And Supply Agreement
An Indian law-governed agreement establishing terms and conditions for the regular supply of goods between a supplier and purchaser.
Download
Material Supply Agreement
An Indian law-governed agreement establishing terms for regular material supply, including quality, delivery, pricing, and regulatory compliance requirements.
Download
Power Supply Agreement
An Indian law-governed agreement establishing terms for electrical power supply between generator/supplier and purchaser, including technical, commercial, and regulatory requirements.
Download
Supply Of Services Agreement
An Indian law-governed agreement establishing terms and conditions for the provision of services between a service provider and client.
Download
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)