National Medical Products Administration (NMPA)

Published on: 18 October 2023

Introduction

The CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which reports to the Chinese Ministry of Health.

In the dynamic landscape of medical device regulation, understanding the classification system is crucial for manufacturers looking to navigate the requirements set forth by regulatory bodies. In China, the National Medical Products Administration (NMPA) employs a classification system that categorizes medical devices into different classes. This blog will provide insights into NMPA’s classification system, shedding light on the distinctions between various device classes.

NMPA classifies medical devices into three main classes: Class I, Class II, and Class III. The classification is based on the potential risks associated with the devices, with Class I representing the lowest risk and Class III the highest.

Class I: Low-Risk Devices

Class I devices pose the lowest risk to patients and users. These devices are typically non-invasive and simple in design. Examples include tongue depressors, bandages, and basic surgical instruments. Manufacturers of Class I devices are required to submit a product filing to the NMPA but are not subject to a comprehensive review.

Class II: Moderate-Risk Devices

Class II devices have a moderate level of risk and complexity. This category includes devices such as infusion pumps, X-ray machines, and certain diagnostic reagents. Manufacturers of Class II devices need to undergo a technical review, and their products require NMPA approval before entering the market.

Class III: High-Risk Devices

Class III devices represent the highest level of risk and complexity. These include implantable devices, certain diagnostic imaging equipment, and high-risk in vitro diagnostic reagents. Manufacturers of Class III devices must undergo a more rigorous review process, including clinical trials, to demonstrate the safety and efficacy of their products.

Navigating the Regulatory Process

Manufacturers seeking to bring medical devices to the Chinese market must carefully assess the classification of their products to determine the regulatory requirements. It’s essential to engage with a qualified regulatory affairs consultant or representative in China to ensure compliance with NMPA regulations.

Conclusion

Understanding the classification system implemented by NMPA is a pivotal step for manufacturers looking to navigate the regulatory landscape in China. Whether your product falls into Class I, Class II, or Class III, being well-versed in the associated requirements will facilitate a smoother regulatory process. Stay informed, collaborate with regulatory experts, and ensure your medical devices meet the standards set by NMPA for successful market entry in China.

Do you have any questions about NMPA and the classification? Don’t hesitate to contact us, we are happy to help you.

About the author
Rebecca Brust

Marketing & Sales Coördinator

Blog Posts

Find More Insights

Full-service product compliance

Leave it to us.