Alterations in Medical Device and IVD Registration Requirements by Russia

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Alterations in Medical Device and IVD Registration Requirements by Russia

Recently, the changes of the resolution #633 by the Russian Government coordinated Russian medical device registration requirements with Eurasian regulations. It also focused to clarify the In vitro diagnostic (IVD) and MD approval methodology.

The IVD products refer to those reagents, instruments, and systems proposed explicitly for use in the diagnosis of disease or other conditions, comprising a determination of the state of health, for prevention and treatment of a disease or its sequelae. These products are utilized in the collection, preparation, and examination of specimens drawn from the human body.

Earlier in the month of June 2018, the Russian Government released the resolution #633 and recommended significant multiple changes in the method of registration of medical devices in Russia. It provided:

  • Instead of the present two-step pathway, the simplification of the registration process of in-vitro diagnostics (IVD) being one-step expert evaluation (expertise) for registration. Subsequently, all classes IVDs pass through simplified registration method by analogy with type I and non-sterile type IIa medical devices;
  • Necessary changes for the list of reasons, requirements and timelines for regulatory renewals (amendments of the registration certificates and amendments of documents of the registration dossier) for already registered devices; the list of cases when expert assessment (expertise) is not obligatory for re-registration;
  • Up-to-date requirements for documents of registration file for IVDs and medical devices with the pharmaceutical unit;
  • An extension of the list of reason for registration rejection and cases in case of the registration certificate may be withdrawn/annulled,  
  • Other slight amendments on registration method, for instance, requirement of imparting information of trademark, clarification of number of feasible additional document requests from the assessment body and description of administrative requirements for the applicant.


Medical Devices In Russia

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Russia Released Multiple Changes in Medical Device and IVD Registration Requirements

Regulatory, Pain
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