| Product registration and market access |
Equipment placed on the Chinese market should have the appropriate medical-device registration or filing status for its risk classification and intended use. |
National Medical Products Administration (NMPA) requirements; product registration certificate or filing information. |
Valid registration or filing details, model consistency, intended-use documentation, and Chinese labeling. |
Verify the certificate or filing before rental, delivery, installation, or clinical use. |
Required |
| Supplier qualification |
The rental provider should be legally authorized to conduct the relevant medical-device trading, leasing, storage, or service activities. |
Business license, applicable medical-device operation records, and local regulatory requirements. |
Business license, operating qualification documents, quality-management procedures, and responsible-person information. |
Legal entity, operating scope, and supplied equipment category should be consistent with the rental contract. |
Required |
| Quality-management system |
A documented quality system should control procurement, receiving inspection, storage, delivery, maintenance, complaint handling, and equipment return. |
ISO 13485 is a recognized medical-device quality-management reference; Chinese regulatory requirements may also apply. |
Quality manual, controlled procedures, training records, nonconformity records, and internal audit evidence. |
Traceable procedures covering the full rental lifecycle. |
Recommended |
| Risk management |
Equipment risks should be assessed for intended use, foreseeable misuse, transportation, installation, operation, and maintenance. |
ISO 14971 risk-management principles for medical devices. |
Risk assessment, corrective-action records, safety notices, and documented operating limitations. |
Risk controls should be linked to user instructions, inspection activities, and maintenance plans. |
Recommended |
| Electrical and functional safety |
Electrically powered equipment should be safe for its intended clinical environment and configuration. |
Applicable provisions of IEC 60601-1 and relevant collateral or particular standards, where applicable. |
Safety-test reports, electrical-leakage test records, grounding checks, alarm tests, and functional verification. |
Pass current safety and functional checks before dispatch and after major repair. |
Required |
| Pre-rental inspection |
Every unit should be inspected before being released to a customer, including accessories, alarms, power supply, labels, and physical condition. |
Supplier-controlled inspection checklist and equipment history file. |
Signed inspection report, equipment identification number, photos where appropriate, and accessory checklist. |
100% completion of the pre-rental checklist before shipment. |
Benchmark |
| Calibration and metrological control |
Measuring functions that affect diagnosis, treatment, or dosage should be calibrated or verified at defined intervals. |
Applicable Chinese metrology requirements, manufacturer instructions, and device-specific procedures. |
Calibration certificate, verification label, due date, reference-standard traceability, and out-of-tolerance procedure. |
No overdue calibration for measurement functions used in the rental period. |
Required |
| Preventive maintenance |
Maintenance intervals should be based on manufacturer instructions, operating hours, risk, service history, and environmental conditions. |
Manufacturer service manual, risk-based maintenance plan, and documented work orders. |
Maintenance schedule, completed work orders, replacement-part records, and technician sign-off. |
Maintenance status should be current at dispatch and visible in the equipment record. |
Required |
| Corrective maintenance response |
The rental agreement should define how faults are reported, diagnosed, repaired, escalated, and closed. |
Contractual service-level agreement and corrective-action procedure. |
Support contact, ticket number, response-time commitment, repair report, and closure confirmation. |
Recommended target: acknowledgement within 4 business hours and a documented action plan within 1 business day. |
Benchmark |
| Replacement or contingency equipment |
Critical equipment should have a documented continuity plan when repair cannot be completed within the agreed service window. |
Rental contract, risk assessment, customer continuity requirements, and equipment availability records. |
Replacement-unit procedure, spare-unit inventory status, escalation contacts, and transport plan. |
For clinically critical equipment, define a replacement or alternative-equipment route before delivery. |
Recommended |
| Cleaning and disinfection |
Reusable equipment and accessories should be cleaned, disinfected, or reprocessed according to material compatibility and intended use. |
Manufacturer instructions, infection-control procedures, and applicable Chinese healthcare requirements. |
Cleaning record, disinfectant details, reprocessing status, disposable-component control, and release sign-off. |
Equipment should be released only after documented cleaning and visual inspection. |
Required |
| Packaging and transport protection |
Packaging should protect equipment from shock, vibration, moisture, dust, temperature extremes, and unauthorized access. |
Manufacturer transport instructions, contractual packaging requirements, and applicable logistics controls. |
Packaging specification, shock or tilt indicators where needed, packing list, and damage-reporting process. |
Packaging must be suitable for the equipment type, route, season, and delivery environment. |
Required |
| Delivery documentation |
Delivery should include equipment identification, accessories, operating documents, inspection status, and acceptance records. |
Rental contract, delivery note, installation checklist, and acceptance protocol. |
Serial or asset number, packing list, user manual, service contact, inspection report, and signed handover form. |
Customer acceptance should record condition, completeness, installation status, and exceptions. |
Benchmark |
| Installation and user training |
Equipment requiring configuration, connection, or clinical operation training should not be placed into service without appropriate instruction. |
Manufacturer instructions, user qualification requirements, and site-specific safety procedures. |
Installation report, commissioning results, attendance record, competency checklist, and training materials in Chinese or agreed language. |
Training should cover normal operation, alarms, cleaning, basic checks, and fault escalation. |
Recommended |
| Delivery lead time |
Lead time depends on equipment availability, destination, installation needs, registration status, and transport conditions. |
Contractual delivery schedule and confirmed inventory status. |
Written quotation, stock confirmation, dispatch date, estimated arrival date, and installation appointment. |
Common planning benchmark: 3–10 business days for available domestic stock; longer for non-stock or specialized units. |
Benchmark |
| Geographic service coverage |
Service capability should match the customer’s site, including remote areas and locations requiring on-site technical support. |
Supplier service network, subcontractor controls, and contractual coverage map. |
Service-area list, technician location, travel-charge policy, remote-support capability, and escalation contacts. |
Confirm on-site response feasibility for the actual delivery address before signing. |
Recommended |
| Asset traceability |
Each rented unit should be uniquely identifiable throughout delivery, use, maintenance, return, and redeployment. |
Asset-management procedure and equipment history record. |
Asset number, serial number, rental history, location record, maintenance history, and return inspection. |
One traceable record per unit, with accessory and repair history linked to the equipment. |
Required |
| Data protection and cybersecurity |
Equipment that stores, transmits, or processes patient or operational data should have defined data-security and decommissioning controls. |
Customer cybersecurity policy, applicable Chinese data-protection requirements, and manufacturer security instructions. |
Access-control procedure, software update policy, data-erasure confirmation, account reset, and incident-reporting process. |
Remove customer data and reset user access before redeployment or return to inventory. |
Required |
| Return inspection and redeployment |
Returned equipment should be assessed for damage, contamination, missing accessories, operational status, and maintenance needs before the next rental. |
Return checklist, cleaning procedure, maintenance procedure, and contract condition report. |
Return inspection report, cleaning release, damage assessment, accessory reconciliation, and redeployment approval. |
Do not redeploy a unit until return inspection, cleaning, safety testing, and record updates are complete. |
Benchmark |
| Contract transparency |
The agreement should clearly define rental period, pricing, deposits, delivery costs, installation, maintenance responsibility, damage liability, insurance, and termination conditions. |
Signed rental agreement and service-level agreement. |
Itemized quotation, acceptance criteria, repair-cost rules, cancellation terms, and dispute-resolution provisions. |
All operational, financial, and regulatory responsibilities should be documented before shipment. |
Required |
