Registration certificate for a medical device is a formal paper issued by Roszdravnadzor and confirming the compliance of devices with the established quality standards. In FCRC, you may order a service of medical device registration according to the national procedure of the Russian Federation. The service includes comprehensive management of your project. This means the entire laborious process of registration dossier formation will be totally controlled by our company.
What you need to provide
Our cooperation will include 3 steps:
- Provide legal documentation about a company and the most complete information about a medical device.
- Promptly answer all questions of our company’s experts.
- Pay for our services and state duties.
In the event of any missing medical device technical document, FCRC’s specialists are ready to prepare them for you.
Main stages
Our specialists are at your service. For you, we will:
- Determine the code and risk class of a medical device and draft an application for state registration.
- Promptly prepare the documents necessary for testing.
- Select certified laboratories and make the most optimal offer in terms of cost and testing time.
- Control the process. Coordinate the number of sample medical devices required for testing with laboratories. Assist in preparing the necessary documents for import for testing purposes.
- Provide a laboratory with samples. Check the test records and, if necessary, make changes to the documentation after your approval.
- Collect a dossier. Agree upon it with a manufacturer’s authorized representative (MAR)/manufacturer.
- File the final dossier to Roszdravnadzor.
- Promptly respond to requests from Roszdravnadzor. If any comment or fault arise, we will address them in a timely manner.
- Notify about the registration process completion. A medical device will be included in the register of medical devices of the Russian Federation, and you will receive the original certificate.
Since 2024, the production inspection for medical devices of risk classes 2a sterile, 2b, and 3 has become mandatory under the Russian Government Regulations No. 135 and No. 136 of February 9, 2022. The inspection is conducted by an authorized public body or accredited entity. The inspection is carried out until the preparation of an expert opinion, i.e., as part of the registration dossier examination.
FCRC registers any type of medical devices:
- Medical devices for in vitro diagnostics
- Medical products
- Consumables
- Medical instruments
- Medical equipment
- Medical furniture
- Dedicated software.
Documents required for registration of medical devices according to national procedure (the Russian Government Regulation No. 1416)
The starting registration requires to provide a minimum package of documents. It includes:
- An extract from the Unified State Register of Legal Entities and an appointment letter for the chief executive officer
- Documentation confirming the existing production site
- QMS conformity certificate (if available)
- Description of a medical device under registration
- Technical documentation (list of technical documentation/specification)
- Medical device photographs
- Operational documentation.
Based on the listed documents, our experts prepare a complete set of documentation for the registration dossier, necessary for the successful state registration. This set is provided to Roszdravnadzor.
Our advantages
Our clients choose us for the following reasons:
- Team of highly qualified specialists
- We guarantee efficiency at all stages
- High result of positive registrations (97.8%)
- We are committed to a transparent pricing policy.
To calculate the cost of registration of a Russian or foreign-made medical device, please, apply by e-mail info@fcrc.consulting or by phone +7 (495) 374-00-19. For accurate calculation of the timing and cost, you can send us a description and all available documentation.