
Amendments to technical dossier for medical devices
Amendments to the documents of the registration dossier are regulated by paragraph 39 of the Decree of the Government of the Russian Federation dated 27 December 2012 N 1416 "On Approval of the Rules for State Registration of Medical Devices" (Order 1416). These changes require expert examination of the quality, effectiveness and safety of the medical device and are implemented within a period not exceeding 35 working days.
Corrected technical file and user manual shall be submitted with the statement for amendments. All changes in the technical file must be confirmed by the results of trials. These may be only biocompatibility trials, for example in the case of changes of the device materials, only technical trials, for example in the case of changes in dimensions, only clinical trials, for example in the case of changes in contraindications or potential complications, or all types of trials at once, for example in the case of new device models.
The manufacturer is obliged to keep the materials of the registration dossier up to date and to notify Roszdravnadzor of any changes made in time. Until the procedure for making changes to the registration dossier is successfully completed, the manufacturer cannot supply both the medical devices themselves with changes and the amended supporting documentation for the devices.
Also, the technical file and user manual for medical devices must currently comply with 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". Thus, medical devices registered before 2017 may require changes to the dossier related to actualisation. Moreover, for any dossier it may be necessary to make changes related to the updating of standards (GOSTs), if they have changed after receiving the RC.
In order to make changes in accordance with paragraph 39 of the Order 1416, it is obligatory to submit the original RC to Roszdravnadzor, even if the changes to be made do not affect the RC form itself.