The legal requirements for medical device registration in China are defined by the National Medical Products Administration (NMPA), which is the regulatory authority responsible for overseeing medical device safety and efficacy in China. The registration process is designed to ensure that medical devices meet the necessary standards for safety, quality, and performance before they can be marketed in China. Below is an overview of the legal requirements for obtaining NMPA certification for medical devices:

1. Device Classification

Medical devices in China are classified into three categories based on their risk levels, as defined by NMPA:

• Class I: Low-risk devices that do not require clinical trials but must comply with safety and performance standards.
• Class II: Moderate-risk devices that require more detailed documentation, and sometimes clinical trials or testing.
• Class III: High-risk devices that pose the greatest potential risk to patients or users and require the most stringent regulatory process, including clinical trials, extensive testing, and detailed documentation.

The classification of the device determines the regulatory pathway and the legal requirements for registration.

2. Legal Requirements for Registration

The following are the general legal requirements for the registration of medical devices in China:

A. Appointing a Local Agent

• Foreign Manufacturers: If a foreign manufacturer intends to sell medical devices in China, it must appoint a local agent (also called an authorized representative) who is based in China. This local agent is responsible for submitting registration applications, communicating with NMPA, and handling post-market surveillance on behalf of the foreign manufacturer.

B. Pre-market Registration Process

The legal requirements for pre-market registration vary by device classification, but they generally include the following steps:

1. Application Submission

   • Manufacturers must submit the required documents and information to NMPA for review and approval.
   • Documents must include product specifications, technical data, quality management systems (such as ISO 13485), labeling, and packaging information.

2. Technical Review and Documentation

   • Class I devices: Manufacturers must submit a filing application to NMPA. This is typically a simpler process and does not require clinical trials. The documents to be submitted include the device description, product testing reports, and quality control systems.
   • Class II devices: Manufacturers need to submit detailed documentation on the device, including safety and performance data. Depending on the device, clinical trial data or a clinical evaluation report may be required. Additionally, the device's technical standards must be met.
   • Class III devices: These devices require the most extensive documentation, including clinical trial data (from either domestic or international trials) and a comprehensive risk management report. NMPA may also require the submission of a clinical evaluation or a post-market surveillance plan.

3. Quality Management System (QMS) Compliance

   • Manufacturers must demonstrate compliance with ISO 13485 (or a similar international quality management standard) to ensure consistent product quality. The NMPA will review the quality management system (QMS) documentation and may conduct an on-site inspection to verify compliance.
   • For foreign manufacturers, NMPA may also conduct an inspection of the production facilities outside China, especially for Class III devices.

4. Product Testing

   • In most cases, devices must undergo national product testing in China or a recognized testing laboratory. NMPA requires that devices meet relevant Chinese national standards (GB standards) or international standards.
   • The product must be tested for its safety, performance, and reliability under conditions of use. Specific tests required depend on the classification of the device and its intended use.

5. Clinical Trials (for Class II and Class III Devices)

   • Clinical trials may be required for Class II and III devices to establish the safety and efficacy of the device in the Chinese population. Clinical trials must comply with the Good Clinical Practice (GCP) guidelines and NMPA’s requirements.
   • For foreign manufacturers, clinical trial data from other countries may be acceptable if the data meets NMPA’s requirements. However, in some cases, NMPA may require additional clinical trials conducted in China.

6. Labeling and Packaging Requirements

   • All medical devices must meet specific labeling and packaging requirements set by NMPA, including Chinese language labeling and Instructions for Use (IFU).
   • Labels must include information such as the device name, intended use, manufacturer’s name and address, model number, manufacturing date, and expiration date (if applicable). The Chinese language requirement is a crucial part of the legal registration process.
   • The package labeling should also meet certain regulatory requirements to ensure the safe transport and handling of the device.

7. Ethics Committee Approval (if required)

   • For Class II and Class III devices, if clinical trials are required, the manufacturer must obtain ethics committee approval for the clinical study. The clinical study must also comply with Chinese GCP (Good Clinical Practice) guidelines.

C. Regulatory Fees

• Registration Fees: NMPA charges registration fees based on the device classification and complexity. These fees can vary depending on the type of device, and they are typically paid at the time of submission.
• Testing Fees: Manufacturers must also bear the cost of the product testing and clinical trials (if applicable). This cost can vary based on the type of device and the number of tests required.

D. Registration Timeframe

The timeframe for the registration process depends on the device classification and the complexity of the application:

• Class I devices generally take 1 to 3 months for approval.
• Class II devices typically require 6 to 12 months for approval.
• Class III devices can take 12 to 18 months or longer, particularly if clinical trials are involved.

The registration process for medical devices in China can be lengthy and requires compliance with various regulatory, technical, and legal requirements.

3. Post-Market Requirements

Once the device is approved and enters the Chinese market, the manufacturer is subject to several post-market obligations, including:

A. Post-Market Surveillance

• Manufacturers must monitor the performance of their devices in the market and report any adverse events or product defects to NMPA.
• NMPA may conduct post-market inspections to ensure compliance with safety standards and ensure the device is functioning as intended.

B. Adverse Event Reporting

• Manufacturers must report any adverse events or incidents involving the medical device to NMPA within a prescribed period. These reports should include details of the event, product identification, and the steps taken to resolve the issue.

C. Device Recalls (if applicable)

• If a device is found to be defective or unsafe, NMPA requires the manufacturer to initiate a recall and notify all relevant stakeholders, including healthcare providers and distributors.
• Manufacturers must follow strict procedures for conducting recalls and must provide regular updates to NMPA on the status of the recall.

D. Re-Registration and Renewals

• Re-registration is required every 5 years for medical devices. The manufacturer must submit a new application for approval, along with updated documentation or any changes to the device.
• In case of modifications to the device, including design changes or material changes, manufacturers must apply for supplementary registration.

4. Legal Basis for Medical Device Registration

The key legal documents and regulations that govern the registration of medical devices in China are:

• The Medical Device Supervision and Administration Regulations (most recent revision: 2021).
• The Measures for the Administration of Medical Device Registration (effective since 2014, with revisions).
• National Medical Device Standards (GB Standards).
• Guidelines for Clinical Trials of Medical Devices.
• Guidelines for Device Labeling and Instructions for Use.

These regulations outline the obligations for manufacturers, registration processes, product testing, clinical trials, post-market surveillance, and other legal requirements.

Summary of Key Legal Requirements for Medical Device Registration in China

1. Device Classification: Determine whether the device is Class I, II, or III.
2. Appoint a Local Agent: Foreign manufacturers must appoint a Chinese-based agent.
3. Submit Registration Application: Provide comprehensive technical documentation and clinical trial data (for Class II and III).
4. Comply with Quality Management Requirements: Demonstrate compliance with ISO 13485 and Good Manufacturing Practice (GMP).
5. Meet Labeling and Packaging Requirements: Ensure all product labels and packaging comply with Chinese regulations.
6. Conduct Clinical Trials: If required, perform clinical trials in compliance with Chinese guidelines.
7. Post-Market Obligations: Report adverse events, perform surveillance, and conduct device recalls when necessary.

Understanding these legal requirements is crucial for medical device manufacturers seeking to enter the Chinese market.

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