.png)
.jpg)
Your current location: News
search
- Preparation Time: Time spent gathering and preparing necessary documents and certifications. This varies depending on how quickly you can compile the required information.
- Confirm that the device is accurately classified as Class B according to SFDA guidelines.
- SFDA Guidelines: Adhere to SFDA guidelines and requirements for periodic updates and changes. These guidelines outline the processes for updating registration information, including device modifications and administrative changes.
- Monitor Device Performance: Continuously monitor the device's performance and safety in the market. Collect and analyze data on device use and effectiveness.
- 2024-09-06Confirm Device Classification: Verify that your device is accurately classified as Class B according to SFDA guidelines.
- This standard specifies requirements for a quality management system (QMS) that demonstrates an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
- Ongoing Compliance: Ensure continued compliance with SFDA regulations, including maintaining quality management systems and adhering to labeling requirements.
- 2024-09-06Detailed Description: Include information on the device’s intended use, functionality, and design.
.png)
Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
Copyright © Guangdong Grzan Group Co.,LTD. All rights reserved 京CP备1234567890号-4
.png)