To apply for RZN certification of Class I medical devices, follow these steps:

1. Prepare Documentation: Gather all necessary documents, including the application form, technical documentation, quality management system details, and proof of compliance.

2. Complete the Application Form: Obtain and fill out the application form provided by Roszdravnadzor. This form can usually be downloaded from their website or obtained from their office.

3. Submit Your Application: Submit the completed application form and supporting documents to Roszdravnadzor. This can be done either online through their electronic submission portal or in person at their office.

4. Monitor the Process: Track the progress of your application and respond to any requests for additional information or clarifications.

Where to Apply:

• Website: Roszdravnadzor provides details and resources for submission.
• Office Locations: Check the website for regional office addresses or contact information for in-person submissions.

Make sure to adhere to their guidelines and ensure all documents are in Russian or translated appropriately.

Contact Us：

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