Obtaining NMPA (National Medical Products Administration) certification for medical devices in China involves complying with specific evaluation criteria and implementation rules. Here are some key points to consider:
Classification and Registration: Medical devices are classified into different categories based on risk and intended use. The classification determines the specific requirements for registration and certification.
Technical Documentation: Detailed technical documentation must be prepared, including information on device design, manufacturing processes, materials used, and performance testing data. This documentation should align with Chinese regulatory requirements.
Quality Management System: Manufacturers must demonstrate adherence to quality management standards such as ISO 13485. The quality management system must cover design controls, risk management, production controls, and post-market surveillance.
Clinical Evaluation: Depending on the risk classification, clinical data and evaluations may be required to demonstrate the device's safety and efficacy. This is particularly important for higher-risk devices.
Testing and Certification: Testing of the device according to relevant Chinese national standards or international standards accepted by China is mandatory. Certification by a designated testing laboratory accredited by NMPA is typically required.
Labeling and Instructions for Use: Devices must be labeled in Chinese with essential information, including device specifications, manufacturer details, and usage instructions. Instructions for use should be clear and comprehensive.
Local Agent: Non-Chinese manufacturers must appoint a local agent in China who is responsible for regulatory compliance and communication with NMPA.
Post-Market Surveillance: Manufacturers are required to monitor the performance of their devices post-market and report adverse events to NMPA as per regulations.
Renewal and Amendments: Certificates issued by NMPA are typically valid for a certain period and may require renewal. Any changes to the device design, manufacturing process, or labeling must be approved by NMPA.
Authorized Representation: Foreign manufacturers must establish an authorized representative in China who can handle regulatory affairs on behalf of the manufacturer.
These criteria and rules ensure that medical devices meet stringent safety and performance standards before they can be marketed and used in China. Working closely with experienced regulatory consultants or legal experts familiar with Chinese medical device regulations is highly recommended to navigate this process effectively.
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