Amendments to registration certificate for medical device in Russia-bg

Amendments to registration certificate for medical device in Russia

Making amendments to the form of the registration certificate (RC) are regulated by paragraph 37 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 do not require an expert examination of the quality, effectiveness and safety of the medical device and are implemented within a period not exceeding 15 working days. The manufacturer may make the following changes in the form of the RС: to change information about the manufacturer, the person in whose name the registration certificate may be issued, change the manufacturing site of medical device, medical device name changes, the number of devices in the composition, labelling However, in practice, in most cases, these changes cannot be made without expert examination. In addition, paragraph 37 of the Order 1416 also regulates the change of the manufacturer's authorized representative (AR), despite the fact that information about the AR is not contained in the form of the RС itself, but is contained in the dossier materials and in the register entry on the Roszdravnadzor website. The manufacturer must notify Roszdravnadzor of changes in time, namely within a period not exceeding 30 days from the date of the changes, and provide Roszdravnadzor with official documents confirming each change. The manufacturer must keep the materials of the dossier up to date, for this reason paragraph 37 of the Order 1416 provides for such a reason for making changes as "change by the manufacturer of a medical device of documents validity contained in the registration dossier". This paragraph relates, for example, to the extension of technical specifications or renewal of ISO certificates. It should also be noted that the power of AR is valid only for the duration of the power of attorney, after the power of attorney expires, the manufacturer must begin the amendment procedure of the AR. In order to make changes in accordance with paragraph 37 of the Order 1416, a obligatory condition is to submit the original of the actual RС (on paper, notarised copy is not suitable) to Roszdravnadzor.

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