China NMPA Certification Process for Medical Devices

The NMPA (National Medical Products Administration) certification process is the regulatory pathway for obtaining approval to market medical devices in China. This process involves several key steps, from pre-submission activities to post-market surveillance. Below is a comprehensive overview of the NMPA certification process and key points to consider when applying for NMPA approval.

1. Pre-Submission Activities

Before starting the application process, it is important to prepare the following:

a) Device Classification

• Medical devices in China are classified into three categories based on their risk level:
  • Class I: Low-risk devices (e.g., non-invasive devices, basic surgical instruments).
  • Class II: Medium-risk devices (e.g., diagnostic equipment, infusion pumps).
  • Class III: High-risk devices (e.g., implants, life-supporting devices, surgical instruments).
• The classification determines the extent of the approval process, including the documentation and testing requirements.

b) Designate a Local Agent

• Foreign manufacturers must appoint a local agent in China to represent them in regulatory matters. The agent will act as a liaison with the NMPA and handle submissions and approvals.

c) Quality Management System (QMS)

• For Class II and Class III devices, compliance with ISO 13485 is mandatory, which outlines the requirements for a robust quality management system. China also requires adherence to Good Manufacturing Practice (GMP) for medical devices.

2. Preparing the Registration Dossier

The registration dossier is a critical part of the NMPA application. It must include comprehensive documentation about the device, its safety, performance, manufacturing processes, and clinical evidence (if applicable).

a) Required Documents for Registration

• Device Description and Intended Use: Detailed information on the device, its design, components, and intended purpose.
• Risk Management Documentation: A risk analysis report following ISO 14971 standards.
• Clinical Evaluation Report (CER): For Class II and Class III devices, a clinical evaluation report is required. This report may include clinical trial data (if clinical trials are required) or a review of existing literature.
• Performance and Safety Data: Test reports showing that the device complies with relevant safety, performance, and regulatory standards (e.g., biocompatibility, electrical safety, EMC).
• ISO 13485 Compliance: Proof of compliance with ISO 13485 or GMP for quality management.
• Manufacturing Information: Details of the manufacturing process, including facility information and supply chain.
• Labeling and Instructions for Use: All devices must have Chinese-language labels and IFU, in accordance with NMPA requirements.

b) Clinical Trials (If Applicable)

• Class II and III devices often require clinical trials to demonstrate safety and efficacy in the Chinese population.
• Clinical trials must be conducted in China and approved by the NMPA before they can proceed. Manufacturers must submit clinical trial protocols to the NMPA for review and approval.
• Class I devices generally do not require clinical trials, although performance testing and safety evaluations must still be conducted.

3. Submitting the Registration Application

Once all the documentation is prepared, the registration application is submitted to the NMPA for review.

a) Submission Process

• Applications must be submitted to the NMPA Center for Medical Device Evaluation (CMDE), which is responsible for reviewing the dossier and conducting technical assessments.
• The submission should include all the required documents in Chinese (except for supporting documents in foreign languages, which must be translated and notarized).
• The NMPA will assign the application to an evaluator who will assess the technical, safety, and clinical data.

b) Submission Fees

• Class I: Low registration fees, typically ¥1,000 to ¥3,000 (approximately USD $140 to $420).
• Class II and III: Higher registration fees ranging from ¥10,000 to ¥50,000 (USD $1,400 to $7,000), depending on the device complexity.

4. Technical Review and Evaluation

The NMPA conducts a thorough review of the application, including an evaluation of the following aspects:

a) Technical Evaluation

• The NMPA will assess whether the device meets Chinese safety, performance, and regulatory standards. This includes ensuring that the device complies with relevant international standards (e.g., IEC, ISO) and Chinese standards (e.g., GB standards).
• In some cases, the NMPA may request additional testing, laboratory evaluations, or inspections of the manufacturing facility.

b) Clinical Evaluation

• For Class II and Class III devices, the NMPA will review the clinical data submitted. If clinical trials were conducted, the NMPA will assess the trial design, results, and relevance to the Chinese market.
• Clinical trials must follow Good Clinical Practice (GCP) and Chinese regulatory guidelines.

c) Inspection of Manufacturing Site

• For certain devices (mainly Class II and III), the NMPA may conduct an inspection of the manufacturing site to verify compliance with Good Manufacturing Practice (GMP).

d) Local Testing

• NMPA may require additional local testing by accredited laboratories in China to verify product safety, performance, and compliance with Chinese standards (e.g., electrical safety, EMC, biocompatibility).

5. NMPA Approval and Registration Certificate

If the NMPA is satisfied with the technical and clinical data, and all regulatory requirements have been met, they will issue an NMPA registration certificate. The certificate allows the device to be marketed and sold in China.

a) NMPA Certificate Issuance

• The certificate is valid for 5 years, after which it must be renewed. Renewal will require an update of the technical documentation and may include post-market data or additional testing.

b) Post-Market Obligations

• After the device is approved, manufacturers are required to comply with post-market surveillance and adverse event reporting regulations. Any issues or incidents related to the device must be reported to the NMPA.
• Manufacturers must also submit annual renewal reports to maintain their NMPA certification.

6. Key Points for Successful NMPA Certification

• Device Classification: Ensure the device is correctly classified (Class I, II, III) to understand the scope of regulatory requirements.
• Local Agent: A Chinese local agent is essential for the NMPA registration process.
• Compliance with ISO 13485 and GMP: Ensure that your quality management system complies with ISO 13485 and GMP standards for medical devices.
• Clinical Trials: If required, conduct clinical trials in China and submit the necessary data to support the device's safety and efficacy.
• Chinese Language Requirements: All documents must be submitted in Chinese, including labels, instructions for use (IFU), and technical documentation.
• Labeling and Packaging: Ensure that your device labeling and packaging meet NMPA requirements, including Chinese language labeling.
• Post-Market Surveillance: Establish mechanisms for monitoring device performance and complying with reporting obligations after approval.

Conclusion

The NMPA certification process is comprehensive and requires detailed documentation, compliance with quality management standards, and, in many cases, clinical trials. The process varies depending on the device classification, with Class I devices being simpler to register than Class II and III devices. Manufacturers seeking to enter the Chinese market must be prepared for a rigorous evaluation process, as well as post-market surveillance and ongoing compliance with NMPA regulations.