| Developers: | Federal Service for Supervision of Health Care (Roszdravnadzor) |
| Branches: | Internet services, Pharmaceuticals, medicine, healthcare |
2021: Product photos and screenshots of software interfaces will be entered into the state register of medical products
In May 2021, the Ministry of Health of the Russian Federation presented new rules for maintaining the state register of medical devices and their manufacturers. One of the most notable innovations is that product photos or screenshots of the software user interface, as well as digital versions of the operating instructions should be included in the database.
As reported in a document published on the federal portal of draft regulatory acts, the register will include information on the date of registration, number and validity of the registration certificate, the appointment of a medical product, its type in accordance with nomenclature classifications, including the code of the All-Russian product classifier by type of economic activity and risk class.
The register should also indicate the name and location of the legal entity of the authorized representative of the manufacturer of the medical product, the manufacturer's details, as well as the address, place of issue of the medical product and information about interchangeable medical products.
The new draft procedure for maintaining the register provides for the inclusion in the register of the electronic image of the manufacturer's operational documentation, including instructions for the use or manuals for the operation of a medical product, as well as a scan of the registration certificate itself.
It is assumed that the register will be updated daily, the receipt of data from it will be free. Roszdravnadzor will provide information from the register upon request within five working days, and at the request of authorities or local governments - within a day.
The explanatory note to the draft decree of the Government of the Russian Federation says that the new regulation on the state register of medical products and their manufacturers is associated with the requirements of the "regulatory guillotine."[1]
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