RUS/134
WTO/TBT
RU Russland
  • 30 - Pharmazeutische Erzeugnisse
  • 90 - Optische, fotografische oder kinematografische Instrumente, Apparate und Geräte; Mess-, Prüf- oder Präzisionsinstrumente, -apparate und -geräte; medizinische und chirurgische Instrumente, Apparate und Geräte; Teile und Zubehör für diese
  • 94 - Möbel; medizinisch-chirurgisches Mobiliar; Bettzeug und dergleichen; Beleuchtungskörper, anderweit weder genannt noch inbegriffen; Reklameleuchten, Leuchtschilder und ähnliche Waren; vorgefertigte Gebäude
2022-09-18
2022-06-23

Wadding, gauze, bandages and similar products (bandages, adhesive plasters, poultices) impregnated or coated with pharmaceutical substances or packaged in molds or packages for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Devices and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic devices, other electromedical devices and vision testing devices (HS 9018); X-ray, alpha-, beta-, gamma-emitting devices; intended or not intended for medical, surgical, dental or veterinary use, including radiographic 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 and treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs) hairdressing chairs and similar chairs with devices for rotation and simultaneously for tilting and lifting; parts of the above-mentioned products (HS 9402).

Draft amendments to the Rules for conducting clinical and clinical laboratory tests of medical devices; (75 page(s), in Russian)

The draft amendments to the Rules for conducting clinical and clinical laboratory tests (studies) of medical devices apply to medical products put into circulation on the territory of the Eurasian Economic Union and envisage the following:

clarification of the concepts;

clarification of the conditions for obtaining clinical data for software that is a medical device;

clarification of the conditions of comparability of medical devices when considering clinical data;

clarification of the procedure for obtaining a permit for testing;

clarification of test requirements;

clarification of the grounds for excluding medical organizations from the unified register of authorized organizations authorized to conduct research (testing) of medical devices for the purpose of their registration; definition of requirements for the technical file of the software that is a medical device; clarification of the form of test reports.