| Summary |
The draft amendments to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their use, apply to medical devices put into circulation in the territory of the Eurasian Economic Union and provide for the following: the possibility, in certain situations, of confirming the compliance of the production conditions of the sterilization site with the established requirements without the inspection organization visiting the sterilization site, which will avoid repeating individual procedures when evaluating the quality management system in order to rationalize the resources of manufacturers of medical devices and inspecting. organizations
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| Product |
Cotton wool, gauze, bandages and similar articles (for example, bandages, Band-Aids, poultices), impregnated or coated with pharmaceutical substances or packaged in forms or packages for retail sale, intended for use in medicine, surgery, dentistry or veterinary medicine (HS 3005); Devices and instruments used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic equipment, other electro-medical equipment and vision testers (HS9018);Equipment based on the use of X-ray, alpha, beta or gamma radiation, intended or not intended for medical, surgical, dental or veterinary use, including X-ray or radiotherapy equipment, X-ray tubes and other X - ray generators, high-voltage generators, shields and control panels, screens, tables, chairs and similar products for examination or treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs); barber chairs and similar chairs with devices for rotating and simultaneously for tilting and lifting; parts of the above-mentioned products (HS Code 9402) |