New Recommendations amended the rules for the registration of different medical devices. New rules shall be applied from 2 July 2021.
According to the Recommendations, for instance, products for laser and photo epilation, or equipment intended for disinfecting the air in healthcare organizations, or disinfectant solutions, cleaning compositions, if such products are specified by the manufacturer for medical use, are medical products.
Particular attention is drawn to the amendments to Section 7 “Software” of the Rules.
Para. 18 of the Rules clarifies criteria of software being a medical device, in particular:
- Software is a computer program or mobile- or web-app, and
- is not an integral part of another medical device, and
- is designed for medical treatment, and
- is designed to assist in clinical decisions based on automatic interpretation of received healthcare data1
The same criteria for software as medical devices were introduced by Roszdravnadzor in its Letter No. 02I-297/20 from 13 February 2020.
Eurasian Economic Commission is also mentioned that the functions of creating screens, business processes, reports, and other presentations, which are used for business processes automating of a healthcare organization, are not data interpretations during software operation.
Moreover, software intended for use by an unlimited number of users for educational, scientific, reference, and information purposes, including selection of a medical specialist, reminding (controlling) the need to take a medicine, providing information from the general characteristics of the medicine and instructions for medical use, are excluded from medical devices.
We believe that new rules will eliminate the need to register software that is not aimed at medical treatment.
1The last criterion was introduced by Recommendations No. 15 dd 29.06.2021