Medical Device Registration
Registration of Medical Devices in Russia and CIS
Medical devices are all products, tools, equipment and accessories used in healthcare, either alone or in combination with other equipment or facilities. Only products designed for medical use that were previously registered in the manner required by Decree No.1416 issued by the Government of the Russian Federation on December 27, 2012 are allowed to be used in Russia.
Registration of medical devices is a mandatory state procedure aimed to monitor the quality and safety of medical products. Elmas offers its services in this area, assisting in obtaining necessary authorizations and approvals and providing support at all stages of the registration process.
More information is provided on our website.
Steps of Medical Device Registration
1. Preparation of technical dossier. Verification of information received from the manufacturer for completeness, preparation of technical and operational documentation in accordance with applicable requirements. Running toxicological, technical tests and electromagnetic compatibility tests on the medical product in the laboratory. If the product is made abroad, special import permit is required to be obtained for test samples. The preparatory stage is concluded by the submission of the product dossier to Roszdravnadzor.
2. Stage 1 of expert review. Analysis of the prepared and submitted dossier. The result of the first stage of the expert review is either the issue of the permission authorizing clinical trials or rejection of the registration application.
3. Stage 2 of expert review. Clinical trials.
4. The stages of the expert review may vary depending on the medical product’s risk category. If all stages of the expert review are successfully completed, the product is inscribed on Roszdravnadzor’s Register of Medical Products. The customer receives a Marketing Authorization enabling the distribution and use of the registered product in the territory of the Russian Federation.
Factors affecting the price of the service:
- Risk class
- Model range
- Presence of pharmaceutical substances
- Belonging to in vitro products
- Availability of similar products registered in Russia
Elmas Group provides a full range of services associated with the registration of medical devices in Russia and CIS countries
1. Preparation of technical and operational documentation
2. Preparation of authorizations and permits to enable the importing of test samples
3. Arranging technical, toxicological and clinical trials of medical products, including in own laboratory
4. Project progress monitoring at all stages of the registration procedure
5. Customer information support: topic-specific information webinars addressing the medical products registration procedure both in Russian and English.
Our clients
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