
Technical dossier for local manufacturers for medical devices
The content of the technical file of a medical device manufactured in Russia, as well as foreign medical devices, is regulated by the Order of the Ministry of Health of the Russian Federation dated 19 January 2017. N 11n "On Approval of Requirements for the Content of Technical and Operational Documentation of the Manufacturer of a Medical Device" (Order 11n). The only distinguishing feature is that, as a rule, a Russian manufacturer instead of a technical document/file has an organization's standard called Technical Specifications (TS). The concept of TS is defined in Article 2 of the Federal Law of 29 June 2015 "On Standardisation in the Russian Federation''. Technical Specifications have specific requirements for the design and content of information in accordance with the ESKD standard 2.114-2016 "Unified System for Design Documentation. Technical Specifications.". For example, TS oblige the manufacturer to establish in detail the methods of control of parameters, norms and characteristics. The important point is that the Russian manufacturer of MD, developed according to TS, before putting into manufacture, must go through certain stages, such as the manufacture of the installation series, conducting qualification trials, correcting the technical file, if required, in accordance with GOST R 15.013-2016 "System of development and putting devices into manufacture. Medical devices". The results of qualification trials are provided to Roszdravnadzor and become a part of the registration dossier. A foreign manufacturer goes through similar stages, but does not provide the results to Roszdravnadzor. Also, a Russian manufacturer must conduct additional trials throughout the MD life cycle, such as acceptance, periodic, type and reliability trials. Like a foreign manufacturer, a Russian manufacturer must keep its technical file (TS) up to date and, if necessary, make changes and issue notices of changes of the TF. The only conditional simplification in registration for a Russian manufacturer is that the device is manufactured on the territory of the Russian Federation, and it is not necessary to obtain the permission for samples import and prepare customs documents before trials, that helps to save time before submitting the dossier to Roszdravnadzor. Also, a Russian manufacturer can represent its own interests in the territory of the Russian Federation and not have an authorized representative, which is impossible for a foreign manufacturer.