The application and evaluation process for obtaining NMPA certification for medical devices in China involves several key steps. Here’s a detailed overview:

1. Determine Device Classification

• Classification: Medical devices in China are classified into three categories (Class I, II, and III) based on the risk they pose to patients.
  • Class I: Low risk; subject to general controls.
  • Class II: Moderate risk; requires special controls.
  • Class III: High risk; requires more stringent regulatory controls, including clinical trials.

2. Compile Required Documentation

Applicants must prepare a comprehensive registration dossier that typically includes:

• Application form: Completed application for registration.
• Product information: Name, model, specifications, and intended use of the device.
• Technical documentation: This includes design and manufacturing processes, quality management system records, and results from safety and efficacy testing.
• Clinical data: For Class II and III devices, clinical trial results are critical to demonstrate safety and effectiveness.
• Risk analysis: A detailed risk assessment following ISO 14971 guidelines.
• Labeling and instructions for use: How the device is intended to be used, including any necessary warnings.

3. Submit Application

• The completed application and relevant documents must be submitted to the NMPA or authorized local regulatory authorities in China.

4. NMPA Review Process

• Initial Review: NMPA conducts a preliminary review to ensure all required documents are submitted and properly formatted.
• Technical Review: A more in-depth review of the documentation, including assessments of safety and efficacy. During this stage, NMPA may request additional information from the applicant.
  • For high-risk devices, this may include a detailed examination of clinical data and may involve consultations with expert panels.

5. On-Site Audit (if applicable)

• The NMPA may conduct on-site inspections of the manufacturing facilities to ensure compliance with regulatory standards and the quality management system. This is more common for Class II and III devices.

6. Approval or Rejection

• After completing the evaluation, the NMPA will issue an approval or rejection decision. If approved, the device receives a registration certificate, allowing it to be marketed in China.

7. Post-Marketing Surveillance

• After approval, manufacturers must engage in post-market surveillance to monitor device performance and report any adverse events to the NMPA. Manufacturers are also required to maintain their quality management systems and comply with ongoing regulatory obligations.

8. Renewal and Amendments

• Registered devices require periodic renewal after five years, and manufacturers must submit any changes related to the device or manufacturing processes to the NMPA for review.

This process can be complex and may require significant documentation and evidence, especially for higher-risk devices. If you have any questions about specific aspects of the process or need clarification, feel free to ask!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn