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Medical Device Supply Agreement
"I need a Medical Device Supply Agreement for my hospital's procurement of cardiac monitoring equipment from a Philippine distributor, with specific provisions for emergency orders and 24/7 technical support, to be effective from March 2025."
1. Parties: Identification of the supplier and purchaser, including complete legal names and addresses
2. Background: Context of the agreement, including supplier's authority to distribute medical devices and purchaser's authority to procure
3. Definitions: Detailed definitions of technical terms, regulatory references, and key concepts used in the agreement
4. Scope of Supply: Detailed description of medical devices to be supplied, including specifications and quantities
5. Regulatory Compliance: Obligations regarding FDA Philippines regulations, permits, and certificates
6. Quality Requirements: Quality standards, testing procedures, and acceptance criteria
7. Ordering and Delivery: Process for placing orders, delivery timeframes, and logistics requirements
8. Price and Payment: Pricing structure, payment terms, and invoicing procedures
9. Warranties and Quality Assurance: Product warranties, quality guarantees, and defect remediation processes
10. Term and Termination: Duration of agreement, renewal terms, and termination rights
11. Liability and Indemnification: Risk allocation, liability limitations, and indemnification obligations
12. Confidentiality: Protection of confidential information and trade secrets
13. Force Majeure: Provisions for unforeseen circumstances affecting performance
14. Governing Law and Dispute Resolution: Choice of Philippine law and dispute resolution mechanisms
15. General Provisions: Standard boilerplate clauses including notices, amendments, and assignment
1. International Shipping Terms: Required if supplier is based outside Philippines, including Incoterms and import requirements
2. Technical Support Services: Include when supplier provides installation, maintenance, or training services
3. Storage and Handling Requirements: Necessary for devices requiring specific temperature control or special handling
4. Consignment Stock Arrangements: Include if devices will be stored at purchaser's facility before purchase
5. Emergency Supply Provisions: Required for critical medical devices or public health facilities
6. Data Protection: Include if the devices collect or process patient data
7. Insurance Requirements: Detailed insurance obligations beyond standard liability coverage
8. Exclusivity Arrangements: Include if there are territorial or customer restrictions
9. Product Training: Required when devices need specialized training for safe operation
10. Recall Procedures: Detailed procedures for product recalls beyond standard warranty provisions
1. Schedule 1 - Product Specifications: Detailed technical specifications of all medical devices covered by the agreement
2. Schedule 2 - Pricing Schedule: Comprehensive pricing details, including volume discounts and price adjustment mechanisms
3. Schedule 3 - Quality Standards and Testing Procedures: Detailed quality control procedures and acceptance testing protocols
4. Schedule 4 - Delivery Schedule and Locations: Specific delivery locations, timeframes, and logistics requirements
5. Schedule 5 - Required Certifications and Documentation: List of required regulatory certificates, permits, and documentation
6. Schedule 6 - Service Level Agreement: Performance metrics and response times for technical support if applicable
7. Schedule 7 - Storage and Handling Specifications: Detailed requirements for storage, handling, and maintenance of devices
8. Appendix A - Forms and Templates: Standard forms for purchase orders, quality reports, and incident reporting
9. Appendix B - Contact Details: Key contact persons and escalation matrix for both parties
10. Appendix C - Compliance Checklist: Checklist of regulatory and quality compliance requirements
Authors
Healthcare
Medical Devices
Pharmaceutical
Hospital Management
Public Health
Medical Technology
Healthcare Distribution
Medical Equipment
Healthcare Manufacturing
Medical Supplies
Legal
Procurement
Regulatory Affairs
Quality Assurance
Supply Chain
Operations
Compliance
Medical Affairs
Contract Management
Risk Management
Finance
Healthcare Administration
Procurement Manager
Healthcare Facility Administrator
Medical Device Sales Manager
Regulatory Affairs Director
Quality Assurance Manager
Supply Chain Manager
Healthcare Operations Director
Legal Counsel
Compliance Officer
Medical Device Product Manager
Contract Administrator
Chief Medical Officer
Hospital Administrator
Purchasing Director
Medical Equipment Specialist
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