In China, Class I medical devices are categorized as low-risk devices that do not require stringent regulatory control compared to higher classes. Here’s how you can apply for Class I medical device registration with China NMPA:

Definition of Class I Medical Devices in China:

Class I medical devices in China are those that pose the lowest risk to patients and users. They typically include devices such as bandages, surgical gloves, and other non-invasive products.

Application Process for Class I Medical Device Registration:

1. Classification Confirmation: Ensure that your device meets the criteria for Class I classification under Chinese regulations. This determination is crucial as it dictates the specific requirements for registration.

2. Local Agent Appointment: If you are a foreign manufacturer, appoint a local agent in China who will represent you throughout the registration process and serve as the point of contact with the NMPA.

3. Compile Technical Documentation: Prepare the necessary technical documentation required for registration, which typically includes:

   • Device description and specifications
   • Manufacturing process details
   • Risk assessment documentation
   • Testing reports (if applicable)
   • Instructions for use (IFU)
   • Quality management system documentation, such as ISO 13485 certification

4. Clinical Evaluation (if required): In some cases, a clinical evaluation might be necessary to demonstrate the safety and performance of the device. However, for most Class I devices, this may not be mandatory.

5. Prepare Application Package: Gather all required documents and information into a comprehensive application package. This typically includes:

   • Completed application form
   • Technical documentation
   • Quality management system documentation
   • Proof of local agent appointment
   • Any additional regulatory declarations or certifications

6. Submission to NMPA: Submit your application package to the NMPA. Ensure that all documents are complete and accurate to facilitate a smooth review process.

7. Review and Approval: The NMPA will review your application and may request additional information or clarifications during the review process.

8. Certificate Issuance: Upon successful review, the NMPA will issue a registration certificate for your Class I medical device. This certificate allows you to legally market and distribute your device in China.

9. Post-Market Surveillance: After obtaining registration, adhere to post-market surveillance requirements, including reporting adverse events and maintaining updated technical documentation.

Key Considerations:

• Regulatory Updates: Stay informed about any changes or updates in Chinese regulatory requirements that may impact your device registration process.
• Local Representation: Having a local agent is essential for navigating regulatory processes and communicating effectively with the NMPA.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn