Registration and Certification of Medical Products (medical equipment) in the Russian Federation and Republic of Kazakhstan.

Medical products are classified according to the degree of potential risk of application on medical purpose as follows:

class 1 - Medical products with a low degree of risk (microscopes, medical scales, audio reaction testers etc.);

class 2à - Medical products with a medium degree of risk (audiometers, laboratory equipment, spirometers etc.);

class 2b - Medical products with a higher degree of risk (cardiochek analyzers, plethysmographs, defibrillators etc.)

class 3 - Medical products with a high degree of risk (implants, endoprostheses, lithotripters etc.)

A maker of medical products (medical equipment) and a distributer, who wants to import and sell medical products on the territory of the Russian Federation and Republic of Kazakhstan must get:

1. Refistration Certificate of Roszdravnadzor of the RF Ministry of Health & Social Development;

2. Obligatory Certificate GOST R in an accredited certification body of Federal Agency on Technical Regulating and Metrology (former GOSSTANDART);

3. Sanitary-and-Epidemiological Conclusions of Rospotrebnadzor of the RF Ministry of Health & Social Development

Our company provides the fullest range of service in the field of registration and certification of medical products, we offer:

- Consultations on questions connected with Registration of medical equipment in a language our client speaks

- Quick and proper translation of documents from any language into Russian

- Expertise of received documents for conformance to the requirements of Roszdravnadzor of the RF

- Arrangement of toxicological, technical and medical (clinical) tests in accredited organizations of Roszdravnadzor

- Preparation of client's documentation for submitting to Roszdravnadzor

- Obtainment of the Registration Certificate of Roszdravnadzor (no expiration date)

- Execution of Obligatory certificate of conformance GOST R for a period of one or three years

- Preparation of documents and submitting them to Rospotrebnadzor

- Obtaining of Hygienic Certificate for 5 years (if necessary)

- Defense of our client's interests in Russian registration bodies

Cost of a Medical Product Registration in Russia includes the following expenses:

- Execution of documents in the product's country of origin and their notarized translation into Russian;

- payment for expenses of an organization providing all kinds of tests, registration, certification, obtaining of Hygienic Certificate;

- payment for examination of documentation and results of the examination made in FSA "Scientific Center for Expertise of Means of Medical Application" and in Scientific Expert Council of Medical Products;

- payment for toxicological, technical and clinical tests;

- state due for registration of a medical product imported to Russia for the first time;

- payment for Obligatory Certificate of Conformance GOST R (for 1, 2, 3 years) and its copies including Registration Certificate Number of Roszdravnadzor and date of issue;

- payment for works on obtaining Hygienic Certificate of Rospotrebnadzor.

The result of collaboration with our Company is obtaining of all permissive documents for medical equipment (medical products) and getting an opportunity to sell your product on the territory of the Russian Federation and Republic of Kazakhstan.