The National Medical Products Administration (NMPA) of China sets various standards for the registration certification of medical devices. These standards cover a broad range of requirements, from product design and clinical trials to labeling and post-market surveillance. NMPA’s standards aim to ensure that medical devices are safe, effective, and of high quality before they are approved for use in China. Below is an overview of the key standards that manufacturers must meet for NMPA registration certification in China:

1. Device Classification Standards

NMPA classifies medical devices into three categories based on their risk levels:

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

The classification of a device dictates the specific regulatory pathway and the applicable standards for registration.

2. General Product Standards

NMPA follows a set of national standards (known as GB standards) for the safety, efficacy, and quality of medical devices. These standards vary depending on the type of device and its intended use. Manufacturers must ensure that their devices comply with the relevant GB standards or equivalent international standards.

Key standards include:

• GB/T 16886 series: Biological evaluation of medical devices, including biocompatibility testing.
• GB 9706.1-2016: General requirements for the safety of medical electrical equipment.
• GB 2828: Statistical sampling methods for inspection.

These are broad categories, and the specific standards for each device depend on its type, technology, and intended medical purpose.

3. Clinical Trial Standards

For Class II and Class III medical devices, clinical trials may be required to demonstrate safety and effectiveness. NMPA has specific requirements for clinical trial design and data submission:

• Clinical Trial Guidelines for Medical Devices (NMPA) – This document provides detailed instructions on how clinical trials for medical devices should be conducted in China, including ethical standards and data reporting.
• Good Clinical Practice (GCP): NMPA follows the Chinese GCP guidelines for clinical trials, ensuring that trials meet ethical and regulatory standards.
• Clinical Evaluation: Clinical data must be presented to demonstrate that the device performs as intended and does not pose undue risk to patients.

Foreign manufacturers may submit clinical trial data from international trials, provided the data complies with NMPA’s guidelines. However, NMPA may also request additional clinical studies in China.

4. Quality Management System (QMS) Standards

Medical device manufacturers seeking NMPA certification must establish and maintain an appropriate Quality Management System (QMS):

• ISO 13485: This international standard for medical devices outlines requirements for a quality management system that manufacturers must adhere to. It covers all aspects of the product lifecycle, from design and development to production, installation, and servicing.
• Good Manufacturing Practice (GMP): Manufacturers must ensure that their facilities and production processes meet GMP standards, which are designed to ensure that medical devices are produced consistently and controlled according to quality standards.

Foreign manufacturers must also comply with GMP regulations for facilities outside of China. NMPA may conduct on-site inspections of manufacturing facilities, including foreign factories.

5. Risk Management Standards

NMPA requires that medical devices undergo risk management assessments during the registration process:

• ISO 14971: This is the international standard for risk management in medical devices. It outlines the process of identifying hazards, assessing risks, and controlling risks to ensure the safety of medical devices.
• Risk Analysis and Mitigation: Manufacturers must demonstrate that risks have been evaluated, controlled, and mitigated through design, labeling, and post-market surveillance.

6. Labeling and Packaging Standards

NMPA has strict regulations for medical device labeling and packaging. Labels must be clear, accurate, and include all required information:

• Chinese Language Requirement: All medical device labels, instructions for use (IFU), and packaging must be provided in Chinese.
• Labeling Information: Labels must include details such as:
  • Device name, model, and specifications
  • Manufacturer’s name and address
  • Registration certificate number (when applicable)
  • Intended use, warnings, and precautions
  • Batch number or serial number
  • Expiration date (if applicable)

Specific requirements may vary based on device type and classification. For instance, sterile devices must indicate the sterilization method used and the shelf life.

7. Product Testing and Performance Standards

For all medical devices, NMPA requires compliance with specific performance and safety standards:

• Testing for Safety and Performance: Devices must meet Chinese national standards (GB standards) or internationally recognized standards such as IEC 60601 for electrical medical equipment.
• Biocompatibility Testing: Devices that come into contact with the body, such as implants or skin-contacting devices, must undergo biocompatibility testing to assess the potential for adverse reactions. Testing is typically done in accordance with the ISO 10993 series, which outlines biological evaluation methods for medical devices.
• Electrical Safety Testing: Devices that involve electrical components must be tested to ensure they comply with safety standards such as IEC 60601-1 (medical electrical equipment safety) and IEC 60601-1-2 (electromagnetic compatibility).

8. Post-Market Surveillance Standards

Once a device is registered and enters the market, manufacturers must comply with post-market surveillance requirements:

• Adverse Event Reporting: Manufacturers must establish systems to monitor and report adverse events or product defects to NMPA. Serious incidents must be reported within a specific timeframe, typically within 10 days for serious adverse events.
• Post-Market Clinical Follow-up (PMCF): Manufacturers may need to conduct ongoing clinical evaluations or studies to monitor the long-term safety and efficacy of the device in the market.
• Device Recalls: If a device is found to have safety issues, manufacturers must initiate a recall and report it to NMPA.

9. Specialized Standards for Certain Device Types

In addition to general standards, NMPA has specific guidelines for certain types of medical devices, such as:

• In Vitro Diagnostic Devices (IVDs): There are specific guidelines for the registration of in vitro diagnostic devices, which include additional testing and clinical data requirements.
• Implants and Active Devices: Devices such as implantable devices (e.g., pacemakers) or active medical devices (e.g., infusion pumps) are subject to additional safety and performance standards.
• Software Medical Devices: Devices with software components must comply with specific standards related to the cybersecurity and software validation processes.

10. NMPA-Specific Guidelines and Procedures

NMPA also provides guidelines that detail the registration process, required documentation, and other procedural aspects of the certification process:

• NMPA Medical Device Registration Guidelines: These guidelines explain the necessary steps and documentation for the registration of various types of medical devices.
• Registration of Overseas Manufacturers: Foreign manufacturers must comply with specific procedures for registering their devices in China, including appointing a local agent and providing additional documentation, such as a Certificate of Free Sale (CFS) from the home country.

11. NMPA Certificate and License

Once the device meets all the regulatory requirements, NMPA issues a Registration Certificate or License. This certificate is required to legally sell and distribute the device in China. The certificate is valid for five years, after which manufacturers must apply for re-registration.

Summary of Key Standards for NMPA Registration

1. Device Classification Standards: Class I, II, III based on risk.
2. Product Safety and Performance Standards: Compliance with GB standards or equivalent international standards (e.g., ISO, IEC).
3. Clinical Trial Standards: Adherence to GCP and NMPA’s clinical trial guidelines.
4. Quality Management System (QMS): Compliance with ISO 13485 and Good Manufacturing Practice (GMP).
5. Risk Management Standards: Compliance with ISO 14971 for risk assessment.
6. Labeling and Packaging: All labels and packaging must comply with Chinese language and content requirements.
7. Post-Market Surveillance: Ongoing monitoring, adverse event reporting, and recalls.

To achieve NMPA registration, manufacturers must align their products and processes with these standards, ensuring safety, efficacy, and quality for the Chinese market.