China's NMPA (National Medical Products Administration) certification is essential for medical devices to be marketed in China. It applies to a broad range of devices, from simple instruments to complex machines, and includes both domestic and imported products.
Scope: NMPA certification is required for medical devices that fall under the following categories:
- Class I Devices: Low risk, such as bandages and simple surgical instruments.
- Class II Devices: Moderate risk, including diagnostic devices and certain types of monitors.
- Class III Devices: High risk, such as implants and life-supporting equipment.
Conditions:
- Pre-market Approval: Devices must be tested and meet Chinese standards. The application includes technical documentation, clinical data (if applicable), and manufacturing quality systems.
- Local Representation: Foreign manufacturers must appoint a local agent in China for registration purposes.
- Quality Management Systems: Compliance with China's Quality Management System (QMS) requirements is mandatory, often requiring ISO 13485 certification.
- Clinical Trials: Some devices may need to undergo clinical trials in China, depending on their risk classification.
The process involves submission to the NMPA, review of documentation, possibly conducting on-site inspections, and obtaining the registration certificate before commercialization.
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