The Medical Equipment Purchase Agreement serves as a critical document for healthcare providers and medical equipment suppliers operating in Indonesia. It is essential when procuring medical devices, diagnostic equipment, or other healthcare-related apparatus that requires specific regulatory compliance under Indonesian law. The agreement ensures compliance with key regulations including Law No. 36 of 2009 (Health Law), BPOM regulations on medical devices, and relevant Ministry of Health regulations. This document is particularly important as it covers not just the commercial aspects of the purchase but also addresses mandatory requirements for medical equipment registration, installation, training, maintenance, and warranty provisions. It protects both buyers and sellers by clearly defining responsibilities, technical specifications, compliance requirements, and after-sales support obligations within the Indonesian healthcare regulatory framework.
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1. Parties: Identification of buyer and seller, including registration details and authority to trade medical equipment in Indonesia
2. Background: Context of the purchase, intended use, and regulatory framework
3. Definitions: Defined terms including technical specifications, regulatory references, and industry-specific terminology
4. Equipment Specifications: Detailed description of medical equipment, including model numbers, technical specifications, and compliance with Indonesian standards
5. Purchase Price and Payment Terms: Price, payment schedule, and currency considerations
6. Delivery and Installation: Delivery terms, installation requirements, and acceptance testing procedures
7. Training and Documentation: Requirements for user training, operational manuals, and technical documentation
8. Warranties and Quality Assurance: Warranties, quality standards, and compliance with Indonesian medical device regulations
9. Regulatory Compliance: Compliance with BPOM requirements, health regulations, and import regulations
10. Maintenance and Support: Maintenance obligations, spare parts availability, and technical support requirements
11. Liability and Indemnification: Liability provisions specific to medical equipment and healthcare context
12. Term and Termination: Duration of agreement and termination provisions
13. General Provisions: Standard clauses including governing law, dispute resolution, and notices
1. Import Requirements: Required when equipment is imported, covering customs clearance and import documentation
2. Software License: Required when equipment includes proprietary software
3. Clinical Training: Required for complex medical equipment requiring specialized clinical training
4. Consumables Supply: Required when equipment requires specific consumables for operation
5. Integration Requirements: Required when equipment needs to be integrated with existing hospital systems
6. Validation and Qualification: Required for equipment needing specific validation processes
7. Environmental Requirements: Required for equipment with specific environmental operation conditions
8. Third-Party Maintenance: Required when maintenance will be provided by authorized third parties
1. Equipment Specifications Schedule: Detailed technical specifications, drawings, and performance requirements
2. Price and Payment Schedule: Detailed breakdown of prices, payment milestones, and payment terms
3. Delivery and Installation Schedule: Timeline for delivery, installation, and commissioning
4. Training Program Schedule: Details of required training programs and competency requirements
5. Maintenance Service Schedule: Maintenance requirements, schedules, and service level agreements
6. Required Certifications: List of required regulatory certifications and compliance documents
7. Warranty Terms: Detailed warranty terms, conditions, and claim procedures
8. Spare Parts List: List of recommended spare parts and their prices
9. Documentation Requirements: List of required technical and operational documentation
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