Medical Device Registration Russia

Medical Device Regulations in Russia and Eurasian Union

https://medicaldevicesinrussia.com/

2. New guidance on quality management system requirements for the registration of medical devices. On February 9 th, 2022, the Russian government released regulation #135 ( link in Russian) and established rules for the inspection of quality …

Medical device registration in Russia - a brief …

https://mdrc-consulting.com/medical-device-registration-in-russia-a-brief-guide/

The Medical Device Registration and Control Department makes decisions regarding registrations and denials of medical devices in Russia. It is also responsible for changes and modification …

Russia Medical Device Registration - Roszdravnadzor …

https://arazygroup.com/medical-device-registration-russia/

Medical Device Regulations and Classification in Russia. REGULATORY AUTHORITY: Federal Service for Surveillance in Healthcare (Rosdravnadzor or RZN). …

How to Register Medical Devices in Russia | RegDesk

https://www.regdesk.co/register-medical-devices-russia/

Registration of medical devices according …

https://kc-prof.ru/en/registration-eaeu/

1. Application by the forms established by appendices No. 2 and 3 to the Rules for registration and examination of safety, quality and …

Russia Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/russia/

Send device information and data to Russian test lab. These documents must be in Russian. Submit import permit to RZN. After RZN issues permit the device must be sent …

Registration of medical devices according …

https://kc-prof.ru/en/registration-russia/

At an average, the registration of medical devices in our company is carried out in the following terms: Class 1 – 6 months; Classes 2a and 2b – 8-10 months; Class 3 – 12 months. If you already have certain …

Medical devices registration in Russia

https://russiadevices.com/

Registration of medical devices is a very rigorous process very similar to the one practiced in Europe. It involves many laboratory tests, clinical studies and document verifications, …

State registration of medical devices and equipment

http://medexpertpro.ru/en/

Full support of the registration process for medical devices in Russia, the European Union and the EAEU countries. Your reliable partner in the registration of medical devices! ...

Registration Process Medical Products in Russia

https://devicemaster.eu/en/blog-en/initial-registration-process-of-medical-products-from-abroad-in-the-russian-federation/

Moscow, 109074. To file the documents for state registration of medical device in electronic form, applicants need to be registered on the web-site: https://esia.gosuslugi.ru. For more information see …