The registration process for medical devices in China through the National Medical Products Administration (NMPA), formerly known as the CFDA, involves a series of comprehensive steps to ensure the safety and efficacy of medical devices. For Class I, II, and III devices, the NMPA process is structured according to risk levels, with Class III devices (high-risk devices) requiring the most detailed documentation and testing. Here’s an in-depth analysis of the application steps:

1. Pre-Application Preparations

• Device Classification: The first step is determining the device's classification based on the Chinese Medical Device Classification Catalog. Devices are classified into three categories:
  • Class I: Low risk, self-assessment for safety and efficacy, no NMPA review required.
  • Class II: Moderate risk, requires NMPA review based on product safety and clinical performance.
  • Class III: High risk, full NMPA review, including clinical trials and detailed testing.
• Manufacturing Site Inspection: For foreign manufacturers, an on-site inspection of the manufacturing facility may be required. This inspection assesses whether the facility complies with Good Manufacturing Practices (GMP).

2. Dossier Preparation

• Application Form: The first document required is the official application form for the medical device registration. This includes detailed information about the manufacturer, device specifications, intended use, and risk class.
• Technical Documentation:
  • Product Information: Specifications, intended use, operating principles, and design.
  • Clinical Data: Required for Class II and III devices, including clinical trial results or studies demonstrating the device's safety and efficacy.
  • Pre-clinical Data: Includes laboratory and bench testing data to prove the safety and performance of the device.
  • Risk Management Reports: A risk analysis report, following international standards like ISO 14971, to demonstrate how risks associated with the device are identified, assessed, and mitigated.
• Quality Management System Documentation: Evidence of compliance with international quality standards, such as ISO 13485. If the manufacturer is overseas, proof of GMP certification may be required.
• Labeling and Instructions for Use (IFU): The labeling and user manual must be in compliance with Chinese regulations, including Chinese language labels and instructions.

3. Clinical Trials (For Class II & III Devices)

• Preclinical Studies: Depending on the device type, preclinical studies are needed to demonstrate performance, safety, and biological compatibility (especially for implants or devices involving direct patient contact).
• Clinical Trials: Clinical data is required for high-risk devices (Class III). This involves performing clinical trials in China or providing foreign clinical trial data that meets Chinese regulatory requirements.
  • Clinical Trial Approval: Clinical trials must be approved by the NMPA prior to initiation. This step includes submission of the trial protocol and ethics committee approval.
  • Clinical Trial Report: After the trials, a report must be submitted to demonstrate that the device is safe and effective in the intended patient population.

4. Product Testing

• Safety and Efficacy Testing: Before registration, the NMPA requires product testing in certified laboratories within China. This could include:
  • Biocompatibility testing (for medical devices that come into contact with patients, such as implants).
  • Electrical safety testing (for devices with electrical components).
  • EMC (Electromagnetic Compatibility) testing.
  • Performance testing and reliability assessments.
• Testing Reports: The test results need to be compiled and submitted as part of the registration dossier.

5. Submission to NMPA

• After completing all required documentation, the application is submitted to the NMPA via the online platform (China National Medical Products Administration - NMPA). The submitted dossier is reviewed by the NMPA, which may request additional information or clarification.
• For devices that fall under Class II or III, a detailed review process takes place, which can take several months.

6. NMPA Review and Approval

• Technical Review: The NMPA conducts a technical review to assess the safety, effectiveness, and quality control of the device. For high-risk devices (Class III), this review will be more comprehensive and may involve inspections of the manufacturing facility.
• Approval Process: If the NMPA is satisfied with the documentation and testing, it issues a Medical Device Registration Certificate (MDRC). This certificate is required to legally market the device in China.

7. Post-Approval Requirements

• Post-market Surveillance: Once approved, manufacturers are required to monitor the device’s performance and report any adverse events or issues to the NMPA.
• Renewal: Medical device registration is typically valid for 5 years for Class II and III devices, after which renewal is required.
• Changes to Product: If there are significant changes to the product (design, manufacturing process, labeling), the manufacturer must submit an amendment to the registration.

8. Ongoing Compliance

• Post-market obligations: NMPA maintains a robust system for monitoring the safety of medical devices after they have entered the market, including adverse event reporting and periodic inspections.
• Exportation and Distribution: For foreign manufacturers, there are additional requirements for distribution, including working with a licensed importer or distributor in China.

Timeline and Cost

• Timeline: The process can take anywhere from 6 months to 2 years, depending on the device class and whether clinical trials are required.
• Costs: The cost of registration can vary significantly based on the device type, testing required, and whether clinical trials are needed. Class III devices generally involve higher costs due to the additional documentation, clinical trials, and inspections involved.

Key Considerations

• Language: All documents, including labels and instructions, must be in Chinese.
• Local Representation: Foreign manufacturers need to appoint a Chinese local agent (responsible for liaising with the NMPA) if they don’t have a presence in China.
• Post-market surveillance: NMPA places emphasis on post-market surveillance, including adverse event reporting and regular inspections.

Overall, the NMPA registration process is rigorous and designed to ensure the safety and effectiveness of medical devices sold in China. It’s important for manufacturers to be thorough in preparing their documentation and to be aware of the specific regulatory requirements that apply to their device.

Contact Us：

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