The National Medical Products Administration (NMPA) in China accepts a wide range of medical devices for registration. These devices are generally classified into three categories based on their risk levels, and each category has different regulatory requirements and processes for registration.

1. Class I (Low Risk) Devices:

These devices are considered to have a low risk to the human body, and typically do not require extensive clinical trials or testing. Class I devices are subject to self-declaration registration, where the manufacturer needs to submit basic product information, quality control documents, and compliance with local standards.

• Examples of Class I devices include:
  • Simple medical consumables (e.g., gauze, bandages)
  • Non-invasive thermometers
  • Basic medical furniture (e.g., examination tables)
  • Tongue depressors

2. Class II (Moderate Risk) Devices:

These devices are more complex and present a moderate risk to patients or users. Class II devices generally require NMPA review and approval, including technical documentation, product testing reports, and often clinical data or performance data. The manufacturer may need to provide evidence that the device meets Chinese regulatory standards.

• Examples of Class II devices include:
  • Blood pressure monitors
  • Ultrasound diagnostic equipment
  • Infusion pumps
  • Diagnostic test kits (e.g., for HIV, pregnancy)
  • Electrocardiogram (ECG) machines

3. Class III (High Risk) Devices:

Class III devices are those that carry a high risk and can have a significant impact on patient health or safety. They typically require clinical trials in China as part of the approval process, as well as extensive technical documentation, product testing, and post-market surveillance data. These devices are subjected to the most stringent regulatory review by the NMPA.

• Examples of Class III devices include:
  • Implantable devices (e.g., pacemakers, joint replacements)
  • Cardiovascular devices (e.g., stents, heart valves)
  • Ventilators and anesthesia equipment
  • Surgical lasers
  • High-risk diagnostic devices (e.g., MRI, CT scanners)

Types of Devices That Require NMPA Registration:

In general, most medical devices used in clinical settings, including consumables, diagnostics, therapeutic devices, and surgical instruments, require NMPA registration. The main categories include:

• In vitro diagnostic (IVD) devices (e.g., glucose meters, pregnancy tests, HIV tests, etc.)
• Therapeutic devices (e.g., defibrillators, dialysis machines, infusion pumps, etc.)
• Surgical instruments (e.g., scalpels, forceps, surgical scissors, etc.)
• Implantable devices (e.g., pacemakers, orthopedic implants, stents, etc.)
• Monitoring devices (e.g., ECG machines, blood pressure monitors, pulse oximeters, etc.)
• Consumables and disposables (e.g., bandages, catheters, needles, gloves, etc.)

Requirements for NMPA Registration:

The registration process generally involves the following steps, which may vary depending on the device class:

• Pre-market approval: Manufacturers must submit an application package that includes technical documentation, clinical or performance testing data, and safety and efficacy evidence.
• Clinical trials (especially for Class II and Class III devices): These are often required to demonstrate the device’s safety and effectiveness in the Chinese population.
• Product testing: NMPA may require the device to undergo testing by a designated laboratory in China to ensure compliance with Chinese standards.
• Local agent: Foreign manufacturers are typically required to designate a local agent or distributor in China to handle the registration process.
• Inspection: For higher-risk devices, the NMPA may conduct an inspection of the manufacturer’s facilities.

Exceptions and Special Considerations:

Some devices, especially low-risk medical devices (Class I), may not require full registration if they meet specific criteria, such as:

• Devices that are similar to already approved products in China (for which an abbreviated registration process may apply).
• Devices that are already authorized for use in other major markets (e.g., EU, US).

Key Resources:

• NMPA Official Website: NMPA - National Medical Products Administration
• Guidelines for Medical Device Registration: NMPA provides detailed guidelines for the registration process for different types of medical devices, including instructions for clinical trials, product testing, and post-market surveillance.

Would you like more details on the specific registration process for a type of device you're working with?

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