The draft law eliminating licensing of medical equipment, regulating legal grounds for setting requirements to introduction, maintenance and evaluation of quality management of medical products and providing for use of medical products upon termination of registration certificate was submitted to State Duma.
The Draft law № 1080292-7 “On the introduction of amendments to certain legislative acts of the Russian Federation concerning circulation of medical products” (hereafter – “the Draft law”) was submitted to the State Duma on December 21, 2020. The Draft law introduces various amendments to the Federal law “On the fundamentals of health protection of citizens in the Russian Federation” (hereafter “the Law on health protection”) and the Federal law № 99-FZ “On licensing of certain types of activities” dated May 04, 2011.
Amendments to licensing of activity on production and technical support of medical equipment. Correlation of medical devices and medical equipmentArt. 2 of the Draft law proposes to amend subpara. 17 para. 1 art. 12 of the Federal law № 99-FZ dated 04 May, 2011 “On licensing of certain types of activities” under. Under the above amendments, only technical support of medical devices will be subject to licensing. Under the effective regulation, “production and technical support of medical equipment” should be licensed, which causes difficulties for manufacturers of medical devices .
The key problem is that the definitions of medical devices and medical equipment should be separated (in our case any equipment is in fact medical device, but not every medical device can be referred to medical equipment). Analysis of legislative acts in the area of production and realization of medical devices and equipment reveals that there’s a lack of clear regulatory criteria for distinguishing between medical equipment and medical devices.
The letter of Federal Service for Surveillance in Healthcare № 01и-112/17 dated January 20, 2017 stipulates the following: if in the Russian Federation there is a registered medical device, characteristics of which correspond to medical equipment and fall within definition in Regulation of Government of the Russian Federation № 649 dated June 03, 2013 “On the approval of Regulation on licensing of production and technical support of medical equipment (with the exception of technical support for self-sustenance of a legal entity or sole proprietor)”, one should apply to Federal Service for Surveillance in Healthcare for obtaining license to commence activity on its production. Consequently, due to lack of clear regulation there is a risk of violating legislation on licensing.
The letter of Federal Service for Surveillance in Healthcare № 01И-1346/18 dated May 29, 2018 “On non-registered medical device” does not distinguish between medical equipment and medical device either. Both definitions are used without terminological clarification. Executive order of the Federal State Statistics Service № 240 dated April 14, 2017 includes both “medical equipment” and “medical devices” terms when referring to medical devices.
Therefore, adoption of the Draft law will allow to eliminate problems emerging due to the absence of criteria of medical equipment in legislation and minimize risks of carrying out unlicensed activities.
Legal entities and sole proprietors with licenses for production and technical support of medical equipment are to obtain the license for technical support of medical devices once again until December 31, 2021.
Management of medical devices qualityThe Draft law supplements art. 38 of the Law on health protection with para. 8.1 stating that production of medical devices subject to state registration shall meet the approved by Russian Government requirements of introduction, maintenance and estimation of medical devices quality management system depending on potential risk of their use. Currently the requirements are introduced in the territory of members of Eurasian economic Union under Resolution of Council of Eurasian Economic Commission № 106 dated November 10, 2017 (the Resolution entered in force in Russia on March 16, 2018).
Moreover, under para. 8.1 art. 38 of the Law on health protection as amended by the Draft law the Government shall adopt the procedure for administration and holding inspections of manufacturing to ensure its consistency with the above requirements, as well as method for determining payment for such inspections. Rules for determination of payment for inspection are currently provided in the Executive Order of the Ministry of Healthcare № 726н dated July 21, 2020.
Requirements to management of medical devices quality are to substitute license requirements to manufacturers of medical devices due to abolition of obligatory licensing of manufacture of medical equipment.
Other amendments to the Law on health protection
Therefore, the Draft law is meant to simplify circulation of medical devices in several ways, for instance, by abolishing licensing of medical equipment manufacture, monitoring safety of medical devices and regulation of circulation of medical devices, preparing for single market of medical devices circulation within Eurasian Economic Union.
- The Draft law includes paragraph (3.1) into art. 38 of the Law on health protection which allows for the use, exploitation and other actions with medical device upon registration certificate validity period expired and if medical device service life has not expired. The circulation of such medical devices is not addressed in legislation but is admissible under the Letter of Ministry of Healthcare № 2071895/25-3 dated September 08, 2015.
- Para. 2 art. 38 of the Law on health protection specifies types of potential risks of medical devices use with their ranking: low, average, high. Such risks were previously missing in the Law on health protection and are now in Annex 2 to the Order of Ministry of Healthcare № 4н dated June 06, 2012 “On the approval of nomenclatural classification of medical devices”.
- The list of medical devices exempt from registration is supplemented. This list will include medical devices imported in Russia to provide medical assistance for medical reasons of a specific patient, medical devices produced in Russia for export outside the Eurasian Economic Union and not intended for use in the territory of the Eurasian Economic Union.
- The definition “poor-quality medical device” is specified. Such definition stresses that medical device shall be regarded as poor-quality device if it does not comply with safety and efficiency requirements to medical devices, as well as requirements to its marking.
The Draft law shall enter into force after 10 days from its official publication.
Ksenia Stepanischeva, Counsel
Sergey Truschin, Associate