The concept of “medical device” includes equipment, apparatus, instruments, devices, kits, complexes, systems with software tools, hardware, appliances, dressings and suture tools, dental materials, sets of reagents, control materials and reference materials, including standard sets of red blood cells, to determine human blood groups and Rh - accessories, as well as calibrators, consumables and other products for:
- prevention, diagnosis (invitro), treatment of diseases, rehabilitation, medical procedures, medical research, replacement and modification of parts of tissues, human organs, restoration or compensation of damaged or lost physiological functions, control of conception;
- impact on the human body in such a way that their functionality is not implemented by the chemical, pharmacological, immunological or metabolic interactions with the human body, but which mode of action may be supported by such means.
Registration is required for all medical devices intended for use in the Russian Federation. Registration of medical devices (MD) is a serious, time-consuming, multistep regulated process.
According to the order № 735 of 30.10.2006, and other normative legal acts of the Russian Federation the registration of medical devices (MD) is carried out by Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor), based on examination of normative documents on MD and the results of technical and clinical trials. Registration of one product takes from 2 to 4 months. The term can be extended if necessary for additional testing.
The preparatory phase involves the development of regulatory documents, gathering information about the efficacy and safety of medical device (MD) and completing the registration dossier.
The assessment of efficacy and safety of medical devices prior to submitting documents to Roszdravnadzor, is carried out in a form of technical and clinical trials on the basis of accredited testing centers, as well as conducting internal testing of compliance of medical device to regulatory documents requirements (technical specifications, GOST, etc.).
After completion of the preparatory phase the documents should be supplied to Roszdravnadzor.
Experts of Roszdravnadzor check the completeness of documentation, classify the product and, if necessary, send to the examination.
The registration certificate is issued in the case of positive conclusion on the results of the examination for an indefinite period and is valid while maintaining all the information unchanged on a medical device, contained in it.
The key to success is competent and responsible approach to both development of the necessary documents and selection of test centers.
Our company strives to facilitate maximally and expedite the registration process for our clients.
We can help to:
- Develop a research program, regulatory document (technical specifications, instructions for use);
- Organize and conduct monitoring of technical testing and clinical trials of medical device in authorized institutions;
- Prepare documents for registration in accordance with the applicable requirements;
- Provide documents to the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor);
- To monitor the examination of the quality, efficacy and safety of medical device;
- To maintain the passage of documents in the Federal Service on Surveillance in Healthcare and Social Development in order to obtain a Registration certificate for medical device and receive the Registration certificate.