.png)
.jpg)
Your current location: News
search
- Class III Classification: Ensure that your medical device is correctly classified as Class III according to Russian regulations. Class III devices are typically high-risk devices that require rigorous evaluation.
- Technical Documentation: Device description, specifications, labeling, and instructions for use.
- Device Description: Detailed information about the medical device, including its design, functionality, and intended use.
- Research Regulations: Understand the Russian Federal Law on the Circulation of Medicines and Medical Devices and Roszdravnadzor’s guidelines for Class III medical devices.
- Roszdravnadzor is the regulatory authority responsible for overseeing medical devices in Russia. All applications for RZN certification must align with its regulations and guidelines.
- Application Fee: The fee for submitting an application to the certification body can vary. It typically ranges from $5,000 to $20,000, depending on the complexity of the device and the certification body’s pricing.
- 2024-08-26Russian Legislation: Ensure compliance with the Russian Federal Law on the Circulation of Medicines and Medical Devices, and the relevant regulations issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
- Research: Understand the Russian medical device regulations and specific requirements for Class III devices.
.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)