The NMPA (National Medical Products Administration) certification and licensing process for medical devices in China involves several detailed steps. Here’s a comprehensive overview:

**1. Preparation:

• Determine Classification: Assess whether the device is Class I, II, or III based on risk level. This classification dictates the requirements and processes.
• Technical Documentation: Prepare detailed documentation, including product specifications, design, manufacturing processes, clinical evaluation, and safety information.
• Quality Management System (QMS): Ensure compliance with ISO 13485 or equivalent QMS standards.

**2. Pre-Submission:

• Local Agent: Foreign manufacturers must appoint a local agent in China to manage the registration process.
• Prepare Documents: Compile required documents such as technical files, clinical trial data, and labeling in Chinese.

**3. Filing Application:

• Submit Application: Submit the registration application to the NMPA through their online portal or directly to a local NMPA office.
• Application Fees: Pay the required application fees, which vary depending on device classification.

**4. Review Process:

• Document Review: NMPA reviews the submitted documents for completeness and compliance with regulations.
• Technical Review: For higher-risk devices (Class II and III), the NMPA may conduct a detailed technical review, which might include assessing clinical trial data.
• On-site Inspection: The NMPA may conduct on-site inspections of manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.

**5. Approval Process:

• Certification Decision: If the review is satisfactory, the NMPA issues a registration certificate or license for the device.
• Additional Approvals: Class III devices may require additional approvals or registrations depending on their specific use or risks.

**6. Post-Market Requirements:

• Post-Market Surveillance: Manufacturers must report adverse events, conduct ongoing safety and performance monitoring, and comply with post-market surveillance requirements.
• Renewal: The registration is typically valid for five years. Manufacturers must renew their registration by submitting updated documents and possibly undergoing additional evaluations.

**7. Product Changes:

• Notify NMPA: Any significant changes to the product, such as modifications in design or manufacturing processes, must be reported to the NMPA. Approval may be required for these changes.

**8. Compliance and Updates:

• Regulatory Changes: Stay updated with changes in regulations and standards, as the NMPA may update requirements based on new regulations or market findings.

Navigating the NMPA certification process can be complex, especially for foreign manufacturers, so it's often advisable to work with a regulatory affairs consultant familiar with Chinese regulations.

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