The NMPA registration procedure for Class III medical devices in China is complex and involves several detailed steps. Since Class III devices carry the highest level of risk, their registration process is the most stringent. Below is a step-by-step guide to the procedure for obtaining NMPA registration for Class III medical devices:

Step 1: Appoint a Local Agent

For foreign manufacturers, it is mandatory to appoint a local agent or distributor in China. The local agent will serve as the point of contact with the NMPA, handle the registration process, and may be responsible for submitting all required documents on behalf of the manufacturer.

Step 2: Product Classification Confirmation

Before beginning the registration process, the manufacturer should confirm that the device falls under Class III. This can be done through:

• Self-assessment based on NMPA classification guidelines.
• Pre-market consultation with NMPA or a registered Chinese testing laboratory for classification confirmation.

If uncertain about classification, manufacturers can request the NMPA to confirm the class of the device, although this step is optional.

Step 3: Prepare Required Documentation

The manufacturer (or local agent) must prepare a comprehensive set of documentation that includes technical, clinical, and regulatory information to demonstrate the safety and efficacy of the device. This is one of the most critical steps in the registration process.

Typical documents required for Class III devices include:

• Application Form: Filled out according to NMPA specifications.
• Product Technical Requirements: Detailed technical information about the device, including specifications, design, intended use, and materials used.
• Quality Management System: Evidence that the manufacturer adheres to internationally recognized quality standards (e.g., ISO 13485).
• Clinical Data: Clinical trial reports or data from studies conducted in China or other recognized regions (if applicable).
  • Clinical trials are typically required for Class III devices to demonstrate safety and efficacy in the target population.
• Preclinical Data: This includes laboratory testing results that demonstrate the device’s performance, safety, and compliance with Chinese standards.
• Device Labeling and Instructions: Including packaging, labeling, user manuals, and contraindications.
• Product Samples: A sample of the device and any accessories for testing and evaluation.
• Manufacturing Facility Information: A copy of the facility inspection report, which may include an audit of the manufacturing site by NMPA or a recognized body.
• Regulatory Certificates: For foreign manufacturers, certificates such as CE marking (if applicable) and FDA approval may be included to support the submission.

Step 4: Submit the Application to NMPA

Once the necessary documentation is prepared, the local agent submits the application to the NMPA Center for Medical Device Evaluation (CMDE). This includes:

• Electronic Submission: The application can be submitted through the NMPA’s online portal.
• Physical Submission: In some cases, physical documents and samples may be required for review.

Step 5: NMPA Evaluation and Review

The NMPA will evaluate the submitted application in detail. The review process involves the following stages:

• Administrative Review: The NMPA will verify that all required documents are complete and in order.
• Technical Review: A technical expert team from NMPA will assess the safety, efficacy, and quality of the device. This review includes the evaluation of preclinical data, clinical data (if applicable), and compliance with Chinese national standards (e.g., GB standards).
• Product Testing: The NMPA may require the device to undergo testing by a designated Chinese laboratory to verify that it meets applicable standards.

Step 6: Clinical Trial Approval (If Required)

For most Class III devices, clinical trials in China are required to demonstrate safety and effectiveness. These trials need to be conducted under NMPA guidelines and approved by the Ethics Committee in China.

• Clinical trials must typically follow Good Clinical Practice (GCP) standards.
• Clinical trial approval from NMPA is necessary before starting any human trials in China.

Step 7: NMPA Inspection (If Applicable)

In some cases, especially for high-risk devices, the NMPA may conduct an on-site inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP). This is particularly important for devices that are directly implanted into patients (e.g., pacemakers, stents).

• The inspection includes reviewing quality control processes, production conditions, and adherence to safety standards.
• The manufacturing facility must comply with both local Chinese regulations and international standards (such as ISO 13485).

Step 8: NMPA Decision

After completing all reviews and inspections, the NMPA will make a decision on the application. The NMPA can:

• Approve the application and issue a Medical Device Registration Certificate.
• Request additional information or modifications to the application.
• Reject the application if the device does not meet the required standards or safety criteria.

Step 9: Post-Market Surveillance and Compliance

Once a Class III device is registered with NMPA, the manufacturer must comply with post-market surveillance requirements. This includes:

• Post-market clinical follow-up (if required).
• Adverse event reporting: Manufacturers must report any adverse events or device malfunctions to NMPA.
• Annual inspection: In some cases, manufacturers may need to submit annual updates on the device’s performance and sales data.

Step 10: Renewal and Maintenance

The NMPA registration certificate for a Class III device is typically valid for five years. After this period, manufacturers must submit an application for renewal. The renewal process may require updated clinical data, safety information, and additional tests.

Estimated Timeline for NMPA Registration

The overall timeline for NMPA registration of Class III devices can vary significantly, but it typically takes around 12 to 18 months from the submission of the application to receiving the registration certificate. The timeline can be influenced by factors such as:

• The complexity of the device.
• Whether clinical trials are required.
• The speed of NMPA’s review and testing processes.

Fees

Fees for NMPA registration vary based on the type of device, clinical trials, and the services required (e.g., product testing, inspections). It is advisable to consult with a local agent or regulatory consultant to get an accurate estimate of the costs involved.

Key Resources:

• NMPA Official Website: NMPA - National Medical Products Administration
• Medical Device Registration Guidelines: NMPA publishes guidelines for Class I, II, and III devices.
• Clinical Trial Guidelines: NMPA provides specific guidelines for conducting clinical trials in China.

If you need more details on specific steps or the necessary documentation for your device, I’d be happy to assist!

Contact Us：

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