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Home
Services
Registration of Medical Devices
Medical Device Registration in Russia Medical Device Registration in EAEU Registration Dossier Amendments Cancel Medical Device Registration Official Inquiry to Roszdravnadzor Registration Dossier Development Medical Device Testing Authorized Representative (AR) Services for Medical Devices in Russia & EAEU
Quality Management System
QMS Development & Implementation for Medical Devices in Russia & EAEU QMS Inspection Support for Medical Device Manufacturers QMS Certification Assistance for Medical Device Manufacturers
Intellectual Property
Trademark Registration in Russia & International Invention Registration in Russia Utility Model Registration in Russia Software Registration in Russia Copyright
Dietary Supplement Registration Product Certification & Declaration Product Certification Exemption Letter Construction Materials Testing Fire Safety Compliance Certification for Products
Licensing
Medical Activity License in Russia Medical Equipment Maintenance License in Russia
Pricing Reviews About Us FAQ Contact Us
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Cancel Medical Device Registration

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Cancel Medical Device Registration Certificate is the official procedure for terminating the market authorization of a medical device in the Russian Federation. This process can be initiated voluntarily by the certificate holder (e.g., when discontinuing a product) or forcibly by the authorized regulatory body upon detection of serious violations that compromise public health and safety.

Key Legal Obligation: The manufacturer or the entity responsible for importing the medical device into Russia is required to notify Roszdravnadzor no less than six (6) months prior to the planned suspension or cessation of production or import of the device. This advance notice is mandatory for a compliant market exit*.

*According to Article 38, Part 25 of Federal Law No. 323-FZ of November 21, 2011.

 

Work Stages

  1. Document Collection & Analysis: We gather and review the current registration dossier and related documents from the Manufacturer or its Authorized Representative (AR)
  2. Application Package Preparation: We prepare the formal Application for Cancellation and all necessary supporting documents as required by Roszdravnadzor
  3. Official Submission: Electronic submission of the complete application package to Roszdravnadzor via the Government Services Portal**
  4. Liaison & Decision: We monitor the process and handle any queries from the authority until the official decision on the cancellation of the state registration is issued
** There is no state duty for this procedure

 

Estimated Timelines for Cancel Medical Device Registration:

Approximately 1 month

 

Our Service Fees for Cancel Medical Device Registration:

From $615

 

Volume Discount: When contracting 5 or more projects, the cost per project starts from $370.

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