About company

Medexpert Ltd. has been working in the Russian market of consulting services in the sphere of medical equipment and medical product manufacturing and turnover since 1999. Within this period the Company has gained the status of highly professional organization efficiently resolving various problems appearing in the course of medical product authorization for the Russian market. More than 100000 clients representing the interests of both the Russian and foreign companies from almost 50 countries all over the world have made use of the information services rendered by Medexpert for that period of time.

Our Company renders the following services:

• Information services in the sphere of registration and certification medical products in Russia;
• Services on obtaining the set of required documents (Marketing Authorizations, certificates etc.) for market authorization of both the local and imported medical products;
• Assistance in obtaining the licenses for medical equipment production and maintenance;
• Organization of training for the specialists in charge of producing and maintaining the devices, units and instrumentation of various types of medical equipment

The Company’s functions within the registration process:

- Preliminary consultation of the Customer in terms of document preparation and their required set;
- Preliminary expertise of the documents, preparation and approval of the application by the Customer and the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor);
- Determination of risk class and code of All-Russian Classification of Products, product classification as per NCP (All-Russian Scientific Research and Testing Institute of Medical Equipment);
- Ensuring compliance of the documents with the applicable requirements, including their translation and notarization;
- Selection of the analogous product and compiling a comparison table of the regulatory document;
- Preparation of the documents (reference, regulatory document, instruction amendment) and test samples;
- Support in toxicological, technical and medical tests;
- Expertise of acts and reports on the tests and evaluations made;
- Amendment of the documents (regulatory document, instructions) based on the test results;
- Final formation of the registration dossier;
- Submission of the application and registration dossier to the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor);
- Selection of Roszdravnadzor expert organization and concluding the contract on the registration dossier expertise;
- Preparation and submission of the document set for expertise;
- Obtaining of the expert conclusion;
- Monitoring of drawing-up process and informing the Customer on its progress;
- Preparation and approval of the Marketing Authorization draft by the Customer and Roszdravnadzor;
- Obtaining the Marketing Authorization drawn up and handing it over to the Customer.

In order to save your time and nerves that can be lost because of bureaucracy existing in each governmental structure, Medexpert Company will take care of all troubles related to document preparation and representation of your interests at all stages of cooperation. Our specialists are high-skilled professionals having a wide range of knowledge; many of us have work experience in large companies from various branches of economy. Our working with the client is based on the principle of customized and flexible approach in order to achieve the optimal result.

The Company's activity covers the entire territory of the Russian Federation. We have our affiliate working successfully in Moscow City. We remain at your disposal for any further explanations and clarifications you may need.

We truly hope that you take a decision on cooperation with Medexpert Company in the nearest future! Looking forward to our fruitful and unique partnership!