The process for obtaining NMPA (National Medical Products Administration) certification for medical devices in China is comprehensive, requiring multiple steps and considerable documentation to ensure compliance with safety, efficacy, and quality standards. Below is a detailed analysis of the key steps involved in applying for an NMPA certification license:

1. Preparation and Classification of the Medical Device

• Classify the Device: The first step is to classify the medical device according to China’s medical device classification system. Devices are categorized into three classes:
  • Class I: Low-risk devices that are subject to self-declaration.
  • Class II: Medium-risk devices requiring a registration process and the submission of clinical data or testing.
  • Class III: High-risk devices requiring extensive documentation, clinical trials, and rigorous regulatory scrutiny.
• Classification Guidance: Correct classification is essential as the process differs significantly depending on the risk level of the device.

2. Determine the Required Documentation

The NMPA requires various forms of documentation, depending on the device's classification. The following are the typical types of documents that need to be prepared:

• Product Technical File: Contains information on the design, manufacturing process, specifications, and intended use of the device.
• Clinical Evaluation Report: This is required for Class II and III devices, and clinical data is necessary to demonstrate the safety and effectiveness of the device.
• Risk Management Report: An evaluation of the risks associated with the device and the manufacturer's plans to mitigate those risks.
• Manufacturing Quality System Documentation: Information on the manufacturing process, quality control procedures, and adherence to Good Manufacturing Practices (GMP).
• Preclinical Testing and Performance Data: This includes the results of laboratory tests, mechanical testing, and other evaluations to demonstrate that the device meets performance standards.

3. Engage a Local Chinese Representative (for Foreign Manufacturers)

• Local Agent Requirement: Foreign manufacturers are required to appoint a local agent in China to handle the registration process on their behalf. The local agent must be a legal entity in China, such as a Chinese distributor, who is authorized to submit documents and represent the manufacturer in dealings with NMPA.
• Power of Attorney (PoA): The manufacturer must provide the local agent with a PoA to act on its behalf during the registration process.

4. Prepare and Submit the Application

• Application Submission: The next step is to submit the application and all supporting documentation to the NMPA through the China Medical Device Registration System (CMDR). The application package includes product specifications, clinical data (if applicable), risk analysis, and quality management system documents.
• Electronic Submission: In some cases, the submission must be made electronically through the NMPA’s official platform, which requires a valid digital certificate.

5. Review and Technical Assessment

• Document Review: After submission, the NMPA will conduct an initial review of the application package. If there are missing or incomplete documents, the NMPA will request the manufacturer to supplement them.
• Technical Assessment: The NMPA conducts a technical evaluation to assess the safety and effectiveness of the device based on the provided documentation, testing reports, and clinical data. If required, NMPA may also request additional laboratory testing or clinical trials.
  • Class I devices: Typically undergo a less extensive review process and can sometimes be approved relatively quickly.
  • Class II and III devices: Require more detailed evaluation and often undergo a comprehensive review of the clinical data and safety reports.
• Site Inspection: The NMPA may request a site inspection of the manufacturing facility to verify compliance with GMP (Good Manufacturing Practices) and to confirm that the device meets the required standards. This inspection may also check for post-market surveillance readiness.

6. Clinical Trials (For Class II and III Devices)

• Clinical Data Requirement: For Class II and III devices, the NMPA often requires clinical trials to demonstrate the device's safety and efficacy. The clinical trials should comply with NMPA’s specific guidelines, including:
  • Approval from an Institutional Review Board (IRB) in China.
  • Compliance with the Good Clinical Practice (GCP) standards.
  • Data from clinical trials conducted within China may be required, although foreign clinical data can sometimes be accepted if they are well-documented and meet Chinese regulatory standards.
• Clinical Trial Registration: The trials must be approved by the NMPA before proceeding. The manufacturer must submit a clinical trial application for approval and ensure that the study is conducted according to NMPA standards.

7. Product Testing

• Laboratory Testing: Depending on the device, the NMPA may require laboratory testing to verify that the device complies with relevant Chinese standards. These tests may include:
  • Electrical safety (for electrical devices).
  • Biocompatibility (for implants or devices that come into contact with the body).
  • Performance testing (for diagnostic equipment or therapeutic devices).
• Designated Testing Organizations: The NMPA recognizes certain designated testing laboratories in China for specific tests (e.g., biocompatibility, electrical safety, etc.). It’s essential that manufacturers use these approved labs to avoid delays.

8. Review by Expert Committee

• Expert Panel Review: For high-risk devices (Class II and III), an expert panel may be convened to review the technical documentation and clinical data. This panel evaluates whether the device meets the required safety and efficacy standards.
• Feedback from NMPA: The expert committee may request clarifications, modifications, or additional data. The manufacturer is required to respond to these requests promptly.

9. Issuance of NMPA Certificate

• Approval and Issuance: If the NMPA is satisfied with the application and any additional information provided, they will issue a Medical Device Registration Certificate. The certificate confirms that the device has met Chinese regulatory requirements and is authorized for sale in the market.
• Manufacturer’s Responsibilities: The manufacturer must maintain the product’s quality standards, ensure proper post-market surveillance, and update the NMPA if there are any changes to the device or manufacturing process.

10. Post-Market Requirements

• Post-Market Surveillance (PMS): After the product is approved and marketed, manufacturers are required to conduct post-market surveillance to track the device’s safety and performance. Adverse event reporting and corrective actions are mandatory.
• Renewal of Registration: NMPA certification is generally valid for 5 years, after which the manufacturer must apply for renewal. This process may involve submitting updated clinical data, performance reports, and manufacturing documentation.

Conclusion:

The NMPA certification process is a comprehensive and multi-step procedure that includes preparation, classification, submission of documents, clinical trials, testing, expert review, and post-market surveillance. It requires thorough planning, preparation of detailed technical documentation, and in some cases, clinical trials and product testing to meet Chinese regulatory requirements. Navigating this process effectively is crucial for obtaining and maintaining market access for medical devices in China.

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