Medical Devices Class II & III Registration Process in China

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China’s recent regulatory updates aim to align with the international standards of the International Medical Device Regulators Forum, as well as the regulatory frameworks of the United States and Europe. Although navigating China’s regulatory environment can be challenging, it remains a crucial market for medical device manufacturers, providing substantial opportunities for growth and expansion. 

Medical Devices Registration in China 

Medical devices in China are classified into three categories based on their potential risk to patients. For detailed definitions of these classifications, refer to this article on the CPC website. 

The Chinese Medical Device Evaluation (CMDE), a National Medical Products Administration (NMPA) division, is responsible for reviewing medical device registration dossiers in China. 

In recent years, the NMPA has significantly revised the regulations for medical device registration in China:  

• Class I medical devices now require product listing instead of product registration, streamlining the process. 
• The new Clinical Evaluation Exempt Catalog lists 2025 Class II and Class III medical devices exempt from submitting a Clinical Evaluation Report. This includes devices such as Medical Air Compressors, Breast Tissue Markers, and Venous Blood Containers, among others.

Registration Process for Imported Class II and Class III Medical Devices in China 

To distribute their Class II and Class III Medical Devices in China, manufacturers need to obtain the Medical Device Registration Certificate.  

Here is a step-by-step guide for your registration process: 

1. Device Class

Determine the class of your Medical Device and plan the strategy and timeline to streamline the registration journey. 

2. Authorized Legal Representative

Overseas manufacturers must contract a local Authorized Legal Representative, a licensed entity in China, to act as their legal agent and handle all regulatory interactions with the NMPA. Chameleon Pharma can support you in identifying a local Legal Representative. 

3. Product Technical Requirements (PTR)

Prepare your Product Technical Requirements (PTR) documentation, including performance benchmarks, safety protocols, and testing methods of your device. 

4. Type Testing Report

Since 2021, the NMPA has allowed manufacturers to submit self-testing reports, eliminating the need to send medical devices to accredited testing institutes in China. Compliance requires possessing the necessary testing capabilities, including qualified personnel and suitable facilities, to conduct self-testing in line with the PTR. 

5. Clinical Trials

For medical devices with overseas clinical testing, ensuring compliance with Chinese regulations and PTR is crucial. NMPA has introduced the Clinical Evaluation Exempt Catalog, exempting certain Class II and Class III devices from clinical trials. If your product is listed, submitting a comparison document demonstrating its essential similarity suffices. However, any disparities must be justified to ensure they don’t pose new risks to product safety and effectiveness.  

6. Regulatory Documentation

In parallel with Clinical Trials, you can prepare the regulatory documents regarding your medical device, including a comprehensive risk management report, complying with China standards.  

7. Registration Application

Prepare and submit your registration application using the Electronic Regulated Product Submission (e-RPS) system provided by NMPA. The initial review by CMDE typically takes 60 to 90 workdays. Address any corrective notices promptly within one year to prevent application rejection. The second CMDE review lasts approximately 60 workdays. Upon successful completion, expect administrative approval within around 20 workdays, followed by the issuance of the Registration Certificate, allowing your medical device entry into the Chinese market. The Certificate remains valid for five years, and holders must apply for an extension six months before expiration to ensure continuity. 

Figure 1. Class II and Class III Medical Devices Registration in China 

Successfully registering medical devices in China requires careful planning and strict compliance with regulations. By following these steps diligently, your market entry journey will be characterized by efficiency and success.  

Chameleon Pharma, with its extensive network of Chinese regulatory experts, would be delighted to support you in this process. We have long-term experience in handling registration and variations for more than 20 years. Contact us today with your individual questions!