In China, the quality assurance system requirement for medical devices is outlined in several key regulations and standards, primarily focusing on ensuring the safety, efficacy, and quality of medical devices marketed and used in the country. Here are the main aspects of the quality assurance system requirement:

1. ISO 13485 Certification: The cornerstone of the quality assurance system requirement for medical devices in China is compliance with ISO 13485. This standard specifies requirements for a quality management system (QMS) specific to the medical device industry. Manufacturers must obtain ISO 13485 certification from a recognized certification body to demonstrate conformity with international QMS standards.

2. Compliance with Chinese Regulations: In addition to ISO 13485, manufacturers must comply with specific Chinese regulations and standards related to medical devices. These regulations outline additional requirements for design controls, production processes, risk management, and post-market surveillance tailored to the Chinese market.

3. Documentation Requirements: Manufacturers are required to establish and maintain comprehensive documentation that demonstrates adherence to quality management principles. This includes documentation related to device design, manufacturing processes, materials used, testing protocols, clinical evaluations (if applicable), and post-market surveillance activities.

4. Implementation of Quality Management Principles: The quality assurance system should encompass all aspects of device development, production, distribution, and post-market activities. It should include procedures for quality control, calibration, validation, verification, and corrective and preventive actions (CAPA) to ensure consistent product quality and compliance with regulatory requirements.

5. Audits and Inspections: NMPA (National Medical Products Administration) or its designated agents may conduct audits and inspections of manufacturing facilities to assess compliance with quality assurance requirements. These audits ensure that manufacturers maintain effective QMS processes and adhere to regulatory standards throughout the lifecycle of their medical devices.

6. Post-Market Surveillance: Manufacturers are required to establish systems for monitoring the performance of their devices once they are on the market. This includes collecting and analyzing feedback from users, reporting adverse events, and taking appropriate corrective actions to mitigate risks and improve device safety and effectiveness.

Overall, the quality assurance system requirement for medical devices registered in China emphasizes the importance of implementing robust quality management practices, obtaining ISO 13485 certification, and complying with specific Chinese regulatory requirements to ensure the safety and reliability of medical devices marketed and used within the country.

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