During the COVID-19 pandemic, the NMPA introduced some flexibility, allowing virtual or remote inspections in some cases. While on-site visits have resumed in many situations, it is possible that some inspections may still be conducted virtually, especially if the manufacturing site is outside China.In summary, an on-site review is part of the NMPA medical device registration process, but its necessity depends on the type of device, manufacturer history, and risk level. Being prepared for this eventuality can help ensure a smoother process.

The NMPA certification process for medical devices in China is governed by a set of comprehensive regulations and standards that ensure medical devices meet the necessary safety, efficacy, and quality criteria. Manufacturers must adhere to a rigorous process that includes compliance with Chinese national standards (GB standards), international standards (ISO, IEC), and specific clinical and pre-clinical testing requirements. The classification of the device determines the level of scrutiny it will undergo during the registration process, with higher-risk devices (Class II and III) requiring more extensive documentation, clinical data, and regulatory review. Additionally, ongoing post-market surveillance is required to ensure that devices remain safe and effective after they are introduced to the Chinese market.

NMPA certification has a profound impact on the design of medical devices. From compliance with safety standards and manufacturing requirements to post-market surveillance and labeling, NMPA’s regulatory framework shapes how products are developed and tested. The process ensures that medical devices are safe, effective, and suitable for use in China, thereby protecting public health. For manufacturers, it is crucial to design products with NMPA’s requirements in mind, from initial concept to final production, to avoid delays or rejections during the approval process.

The NMPA certification process for medical devices is rigorous and time-consuming, especially for Class II and Class III devices. The overall timeline can vary, but for Class I devices, it’s typically around 1–3 months, while Class III devices can take anywhere from 12 to 24 months. Key factors such as device complexity, clinical trial requirements, and the need for on-site inspections can impact the processing time. Manufacturers should plan ahead and ensure that all documentation is complete to help avoid delays in the approval process.

The NMPA audit for medical devices is a detailed and thorough process that evaluates the manufacturer’s compliance with Chinese medical device regulations, the safety and effectiveness of the device, and the quality control systems in place. The audit ensures that medical devices meet high safety standards before entering the market and are continuously monitored for performance post-market. Manufacturers must prepare comprehensive documentation, undergo site inspections, and provide evidence of clinical efficacy and compliance with local standards to pass the audit.

This list provides a comprehensive overview, but specific devices may have additional or slightly different documentation requirements based on their risk class and intended use. Always check with the NMPA or a local regulatory expert for the most up-to-date and specific requirements.

The NMPA’s comprehensive approach—spanning pre-market evaluation, clinical trials, post-market surveillance, and continuous monitoring of devices—ensures that medical devices in China are both safe and effective. By requiring rigorous testing, inspections, and the submission of detailed evidence, the NMPA guarantees that only devices that meet high standards of effectiveness and safety are allowed to enter the market.

The NMPA Class I registration process for medical devices in China is relatively simple compared to Class II and III devices but still requires careful attention to regulatory documentation, submission procedures, and post-market obligations. By following the correct steps, ensuring accurate and comprehensive documentation, and working with local representatives if necessary, manufacturers can achieve a smooth and efficient registration process for their Class I medical devices in China.