According to the Swiss Federal Law on the Medicinal Products Advertising Ordinance (AWV; SR 812.212.5), access to specialized advertising for medical products on the Internet must be protected by a password.
MEDSIL "MedSil" intragastric balloon has passed the mandatory and voluntary GOST R certification procedure. The device is approved for use throughout the territory of the Russian Federation and is included in the National Register of medical devices and equipment. The product has a registration certificate issued by the Federal Service for Supervision in the field of Health Care and Social Development of the Russian Ministry of Health Care and Social Development. The company has adopted the Declaration of Conformity issued by an accredited certification authority — Certification Agency for Medical Devices of Polymeric Materials and Glass Limited Liability Company «MEDPOLYMER-S».
Intragastric balloon «MedSil» passed the toxicology test in the FGU NII FHM Test Laboratory Center of the Federal Service for Supervision in the Field of Health Care and Social Development.
In March 2017, the Notified Body 3ЕС (№2265, Slovak Republic) carried out a certification audit of the factory. As a result of the audit, the conformity of the quality control system of CSC “MedSil” for the design, development and distribution of non-active medical devices “The set of silicone devices for gastric restriction” with the requirements of the international standard EN ISO 13485 :2012 was confirmed. The experts of the notified body found that the medical device "The set of silicone devices for gastric restriction" is manufactured in accordance with the requirements of Directive 93/42/ЕЕС. Certificates were issued authorizing “MedSil” to mark the product with the CE sign and distribute it on the territory of the European Union.
