Category: Services

When a letter of exemption is required The letter of exemption signed by the Ministry of Healthcare serves as to justify that registration is not required for a specific medical product whenever there is disagreement on the issue. For instance, the customs agencies and trade regulators can demand such a document. Who issues the letter of… Continue reading Letter of exemption signed by the Russian Ministry of Healthcare

When a licence is required A licence is indispensable for various types of activities related to medical devices, such as manufacturing, servicing and repairing. A licence is issued to legal entities or entrepreneurs that do not make part of any legal entities. Below you will find a list of the main types of medical devices that require… Continue reading Licence for manufacturing and assuring maintenance of medical products

Federal Service for Surveillance in Healthcare draws state registration applicants’ attention to the Order of the Russian Ministry of Healthcare No. 521n dated 18 July, 2016 Правилами государственной регистрации медицинских изделий, утвержденными постановлением Правительства Российской Федерации от 27.12.2012 № 1416, определено: «Эффективность медицинского изделия – совокупность свойств и характеристик медицинского изделия, обеспечивающих достижение целей предназначения,… Continue reading Roszdravnadzor draws state registration applicants’ attention to the Order of the Russian Ministry of Healthcare No. 521n dated 18 July, 2016 coming into force on 20 August, 2016