Vietnam Sanitary and Phytosanitary Notification Authority and Enquiry Point

Mã WTO	G/TBT/N/KGZ/58
Ngày thông báo	21/08/2025
Loại thông báo	Bình thường
Tiêu đề	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 (2 pages, in Russian); (2 page(s), in Russian)
Tóm tắt	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
Sản phẩm	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)
Quốc gia	Kyrgyz Republic

Tệp đính kèm:
KGZ58.pdf

Thông báo khác:

G/TBT/N/JPN/871/Add.1 - Proposed revision of Ministerial Ordinance on the Specifications and Standards of Feeds and Feed Additives
G/TBT/N/CHN/2102 - National Standards of the P.R.C., Minimum allowable values of energy efficiency and energy efficiency grades of LED products for indoor lighting; (8 page(s), in Chinese)
G/TBT/N/CHN/2101 - National Standard of the P.R.C.,Firefighter's emergency call; (59 page(s), in Chinese)
G/TBT/N/CHN/2100 - National Standard of the P.R.C., Minimum allowable values of the energy efficiency and energy efficiency grades for ducted air conditioners; (6 page(s), in Chinese)
G/TBT/N/CHL/748 - PROYECTO REGULATORIO, INCORPORA A LOS REACTIVOS DE DIAGNÓSTICO IN VITRO PARA CALIFICACIÓN MICROBIOLÓGICA DE DONACIONES EN SERVICIOS DE SANGRE QUE SE INDICAN, AL RÉGIMEN DE CONTROL SANITARIO ESTABLECIDO EN EL ARTÍCULO 111 DEL CÓDIGO SANITARIO (Draft regulation incorporating the indicated in vitro diagnostic reagents for the microbiological qualification of blood donations into the health control system established in Article 111 of the Health Code); (3 pages, in Spanish)
G/TBT/N/BRA/1601 - Public Consultation No. 22, 19 August 2025; (2 page(s), in Portuguese)
G/TBT/N/BRA/1591/Add.1 - Ordinance No. 459, 9 August 2025
G/TBT/N/BRA/1489/Add.1 - SDA/MAPA Ordinance No. 1.358, 14 August 2025
G/TBT/N/BRA/1489/Add.1 - SDA/MAPA Ordinance No. 1.358, 14 August 2025
G/TBT/N/BRA/1489/Add.1 - SDA/MAPA Ordinance No. 1.358, 14 August 2025