The application procedure for registration of NMPA (National Medical Products Administration) Class medical devices in China generally involves several key steps:
Classification: Determine the classification of your medical device according to NMPA guidelines. This classification will determine the applicable regulatory requirements.
Technical Documentation Preparation: Prepare comprehensive technical documentation including:
- Device description and specifications
- Design and manufacturing information
- Risk assessment
- Testing data (e.g., performance, biocompatibility, sterilization)
- Clinical evaluation data (if applicable)
- Labeling and instructions for use
Quality Management System (QMS): Ensure your manufacturing facilities comply with relevant QMS standards (e.g., ISO 13485) and provide evidence of QMS certification.
Clinical Evaluation (if applicable): Conduct clinical evaluations according to NMPA requirements, especially for higher-risk devices.
Testing: Perform necessary testing to demonstrate compliance with Chinese standards and regulations, including performance and safety tests.
Technical Review: Submit your application to NMPA and undergo a technical review process where experts evaluate your documentation and test reports.
On-site Inspection (if applicable): Depending on the risk classification and other factors, NMPA may conduct on-site inspections of manufacturing facilities.
Approval: If your application meets all requirements and passes review, NMPA will issue a registration certificate allowing your device to be marketed in China.
Post-Market Surveillance: Implement post-market surveillance activities as required by NMPA to monitor device performance and safety after it enters the market.
It's essential to engage with a local regulatory consultant or legal representative in China familiar with NMPA regulations to navigate the process effectively, as requirements and procedures can be complex and subject to change.
.png)
