One of the issues that has been widely discussed recently is that the procedure for registering medical software as a medical device is too lengthy, according to a number of developers.
According to our information collected when communicating with the companies that have passed such registration, if the software is classified according to the minimum 1st class of potential risk – the process may take 6 months or more and may cost IT companies about 600-900 thousand rubles.
If the system falls under the 2a class of risk and above – then, as our colleagues assured us, registration can take at least 1 year and cost from 1 million rubles. Some developers said that they have this process lasts for 1.5 years and still have not been able to register.
At the round table “Digital Healthcare. Formation of tools for the regulation of medical software”, organized by the Committee of the Federation Council on Social Policy together with the Association “National Medical Knowledge Base”, this issue was also raised.
The representatives of Roszdravnadzor, who were present at the event, did not agree with the concern about this issue, assuring that today any developer can pass the state registration of medical software product for 30 days. Let’s try to understand why the developers’ assessments are so different from those of Roszdravnadzor experts.
Brief overview of the regulatory framework
Let’s start, of course, with the definition of the term “medical device”. Article 38 323-FZ states that “Medical devices are any instruments, apparatus, instruments, equipment, materials and other products used for medical purposes alone or in combination with each other,
as well as with other accessories necessary for the intended use of these products, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases,
monitoring of the human body, medical research, restoration, replacement, alteration of anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is not realized through pharmacological, immunological,
genetic or metabolic effects on the human body. Medical products can be considered interchangeable if they are comparable in function, quality and technical characteristics and can replace each other.
It should be noted that, in the opinion of market participants, this definition is too broad, allowing for a fairly free interpretation by experts of the regulator, as well as by law enforcement agencies and courts.
Nevertheless, the following discussion and analysis will be carried out, understanding by medical software (MVE) exactly the software that the regulator can refer to as medical devices (MIs).
According to Clause 4 of the same 38th Article 323-FZ, “On the territory of the Russian Federation the circulation of medical devices registered in accordance with the procedure established by the Government of the Russian Federation and authorized by the federal executive authority” is permitted.
П. Article 15, paragraph 38, reads as follows: “It is prohibited to manufacture: 1) medical devices not included in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, except for medical devices,
produced for testing and (or) studies; 2) falsified medical devices”. Thus, the 323rd Federal Law prohibits the production of MI if they are not included in the state register of medical devices.
Violation of the ban on the production, as well as the use of unregistered medical devices, is punishable by administrative and criminal prosecution.
According to Article 6.28 of the Code of Administrative Offences, “Violation of the established rules in the sphere of circulation of medical devices, if these actions do not contain signs of a criminal act,
shall entail the imposition of an administrative fine on citizens in the amount of two thousand to four thousand rubles; on officials – from five thousand to ten thousand rubles; on legal entities – from thirty thousand to fifty thousand rubles.
Article 238.1 of the Criminal Code clarifies what such a criminal act is: “Production, sale or import into the territory of the Russian Federation of falsified medicines or medical devices, or sale or import into the territory of the Russian Federation of substandard medicines or medical devices, or illegal production,
sale or import to the territory of the Russian Federation for the purpose of sale of unregistered medicinal products or medical devices, or production, sale or import to the territory of the Russian Federation of falsified biologically active additives containing pharmaceutical substances not declared at the state registration, committed on a large scale.
According to item 2 of this article “The cost of medicinal products, medical devices or biologically active additives in the sum exceeding one hundred thousand roubles is recognized as the large size in the present article”.
In other words, if the developer of an IGO has sold its solution to the amount of over 100 thousand rubles. – is criminal responsibility. If less, it is administrative. The Criminal Code provides for the following punishment:
- If it is simply the sale of unregistered PMI: forced labor from 3 to 5 years, or imprisonment from 3 to 5 years with a fine of 500 thousand rubles to 2 million rubles.
- If he did it by a group of persons by prior agreement or by an organized group of persons, or such IGO entailed causing serious harm to health or death of a person – the term from 5 to 8 years with a fine from 1 million rubles to 3 million rubles.
- If the same resulted in the death of 2 or more persons due to negligence – the term of 8 to 12 years with a fine of 2 to 5 million rubles.
The practice of criminal prosecution for the sale of unregistered medical software, alas, already exists in our country, and the prosecution is after the registration, for the sale of unregistered MI earlier.
The rules of registration of any medical devices, according to paragraph 10 of Article 38 323-FZ, are determined by the Government of the Russian Federation, and it has made a resolution № 1416 from 27.12.2012 “On approval of the Rules of state registration of medical devices”. Paragraph 3 of this document states that the state registration of medical devices is carried out by Roszdravnadzor.
P. 5 states that state registration is conducted “… based on the results of technical tests, toxicological studies, clinical trials, which are forms of conformity assessment of medical devices, taking into account the classification depending on the potential risk of their use, and examination of quality, efficiency and safety of medical devices, taking into account the classification depending on the potential risk of their use …”.
The order and terms of state registration of medical devices are established by the Order of the Ministry of Health of the Russian Federation of 14.10.2013 № 737n “On approval of the Administrative Regulations of the Federal Service for Supervision in the Sphere of Healthcare for the provision of state services for state registration of medical devices”.
Classification rules for medical devices, including the division into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification of medical devices, are regulated by the Order of the Ministry of Health of the Russian Federation of 06.06.2012 No. 4n “On Approval of the Nomenclature Classification of Medical Devices”.