Yes, NMPA (National Medical Products Administration) registration in China is applicable to specific categories of medical devices, and each category is subject to different regulatory requirements based on the level of risk the device poses to patients or users. The NMPA classifies medical devices into three categories (Classes I, II, and III), with the requirements for registration varying depending on the classification.

1. NMPA Registration by Device Classification

The classification of medical devices is based on their potential risk, complexity, and intended use. Devices that pose a higher risk to patients generally require more stringent regulatory oversight, including more detailed documentation, clinical trials, and testing.

Class I (Low Risk)

• Definition: Class I devices are considered low-risk medical devices that pose minimal potential risk to the human body. These devices typically do not require clinical trials for registration but must meet basic safety and performance requirements.
• Examples:
  • Bandages, basic medical gloves, some dental instruments, non-invasive thermometers, and simple surgical instruments.
  • These devices are subject to a declaration of conformity and require self-assessment by the manufacturer.
• NMPA Registration: For Class I devices, the manufacturer is required to submit an application to the NMPA, including a product description, safety documentation, and proof of compliance with applicable standards. These devices are typically not required to undergo clinical trials.

Class II (Moderate Risk)

• Definition: Class II devices are considered to have a moderate risk to patients and generally require more detailed documentation and sometimes clinical data to support their safety and efficacy.
• Examples:
  • X-ray machines, infusion pumps, oxygen concentrators, certain diagnostic equipment, hearing aids, dental implants, and blood glucose meters.
  • Clinical trials or performance testing may be required, depending on the device's complexity and intended use.
• NMPA Registration: The registration process for Class II devices involves submitting technical documentation, clinical trial data (if necessary), and quality management system certifications (ISO 13485). The device may undergo NMPA review to ensure it meets safety, performance, and regulatory standards. The NMPA may also inspect the manufacturing facility.

Class III (High Risk)

• Definition: Class III devices are high-risk devices that directly affect or support vital human life functions. These devices pose the highest risk to patients and require the most extensive review process, including clinical trials, safety performance data, and post-market surveillance.
• Examples:
  • Pacemakers, prosthetic devices, blood dialysis machines, implantable devices, and some advanced diagnostic imaging systems.
  • These devices are subject to the most comprehensive regulatory requirements, including extensive clinical trials, testing data, and evidence of compliance with Chinese national standards.
• NMPA Registration: The registration process for Class III devices is the most complex and involves detailed documentation including clinical data, performance test reports, risk assessments, and post-market surveillance plans. The NMPA will review this data and may require on-site inspections of the manufacturing site. Clinical trials in China may be required unless the device is already approved in another country with recognized regulatory frameworks (such as the EU or the US).

2. Specific Categories and Sub-categories of Medical Devices

In addition to the general Class I, Class II, and Class III categories, the NMPA also regulates certain types of medical devices that fall within specific sub-categories. The regulatory requirements can vary depending on the type and intended use of the device.

Some specific categories of medical devices that require NMPA registration include:

• In-vitro diagnostic devices: These devices, such as blood glucose meters, diagnostic reagents, and certain laboratory equipment, are regulated under their own set of rules. These devices are typically classified as Class II or Class III, depending on the intended use.

• Implantable devices: Devices such as pacemakers, heart valves, orthopedic implants, and intraocular lenses generally fall under Class III due to their high risk and complexity.

• Active medical devices: Devices that depend on an external power source for functioning, such as ventilators, defibrillators, infusion pumps, and diagnostic imaging systems, are typically Class II or III devices depending on their level of risk.

• Cosmetic medical devices: Devices used for cosmetic purposes (e.g., laser hair removal, cosmetic injectables) often require registration under specific NMPA guidelines for medical devices used in aesthetic procedures. These may fall under Class II or III depending on their function.

• Software as a medical device (SaMD): Certain types of software used for medical purposes, such as diagnostic apps or devices used in monitoring health conditions, may also be subject to NMPA registration. The classification depends on the software's risk level (e.g., diagnostic software would be higher risk and classified as Class II or III).

• Sterilization devices: Devices that are used to sterilize other medical devices, such as autoclaves and sterilizers, are generally regulated under Class II or III based on their complexity.

3. Process for NMPA Registration by Device Category

The registration process varies based on the risk class of the device. Below is a brief overview of the steps involved for each category:

Class I Devices

1. Self-declaration of Conformity: Submit required documents, including the product description, safety compliance data, and proof of GMP compliance (if applicable).
2. NMPA Registration Application: Submit the application form and required documentation to the NMPA.

Class II Devices

1. Pre-market Approval Application: Submit a more detailed application to the NMPA, including technical documentation, clinical performance data (if applicable), and quality management system documentation.
2. Review and Testing: The NMPA reviews the application and may request additional clinical data or post-market surveillance plans.
3. NMPA Certification: Upon successful evaluation, the NMPA issues a registration certificate for the device.

Class III Devices

1. Pre-market Approval Application: Submit comprehensive documentation including clinical trial data, safety and performance testing, and compliance with national standards.
2. Clinical Trials: Depending on the device, the NMPA may require clinical trials conducted in China.
3. NMPA Review and Inspection: The NMPA reviews the application and may inspect the manufacturer’s facilities.
4. NMPA Certification: After successful review, the device is granted a registration certificate.

4. Conclusion

NMPA registration in China is indeed applicable to specific categories of medical devices, with regulatory requirements tailored to the risk level, complexity, and intended use of the device. Manufacturers must comply with the appropriate requirements based on whether their device falls into Class I, Class II, or Class III, and whether additional clinical trials, performance testing, or inspections are required.

For each category, it is essential for manufacturers to be aware of the specific documents, data requirements, and timelines involved in the registration process, as well as any unique rules for sub-categories such as in-vitro diagnostics, implantable devices, and active medical devices.

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