Introduction
According to Russian legislation, clinical decision support systems (CDSS) and most artificial intelligence systems for healthcare are medical devices. Therefore, they require appropriate state registration.
The process of registering software as a medical device is rather complicated. It is thoroughly regulated by law and is often complex and long-lasting.
Moreover, recently the Ministry of Health, together with Roszdravnadzor, has been working closely on the targeted improvement of regulatory acts in the field of software medical devices, including those using artificial intelligence. The fundamentals of normative and technical regulation of artificial intelligence are determined by Government Decree No. 2129-r of August 19, 2020, which approved the "Concept for the regulation of artificial intelligence and robotics until 2024".
The purpose of the document is to establish the main approaches to changes in Russian regulation, which will allow the creation and application of AI technologies and robotics in various fields including healthcare. This should help to accelerate economic growth and competitiveness of the national economy, improve the welfare and quality of life of citizens, ensure national security and law and order, as well as achieve Russia's leading positions in the world in the field of AI.
The main tasks of regulation in this area: the creation of mechanisms for simplified implementation of products using AI and robotics; establishment of legal responsibility in the application of AI and robotic systems, development of insurance institutions; improving the data circulation regime; creation of a national system of technical regulation and conformity assessment; development of a set of measures to encourage technology development.
In order to help to simplify the preparation and registration of software as a medical device, K-SkAI specialists have developed the present review.
A brief overview of regulations
Let's start by defining the term “medical device”. Article 38 of Federal Act No. 323 of Russian Federation states the following: "Medical devices are any instruments, machines, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as with other accessories necessary for the use of these products, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment of diseases and medical rehabilitation, monitoring of the state of the human body, conducting medical research, restoration, replacement and changes in the anatomical structure or physiological functions of the body, preventing or terminating a pregnancy. The functional purpose of these devices is not realized by pharmacological, immunological, genetic or metabolic effects on the human body. Medical devices can be recognized as interchangeable if they are comparable in functionality, quality and technical characteristics and can replace each other."
According to many market players and software developers, this definition is way too broad, allowing for a free interpretation by both experts of the regulator and law enforcement agencies and courts. Nevertheless, in our further discussion and analysis, we will understand by special software the software that the regulator and supervisory authorities can think of as a medical device.
According to clause 4 of the same article 38 of Federal Act No. 323, "Circulation of medical devices, registered in the manner established by the Government of the Russian Federation or the federal executive body authorized by it, is permitted on the territory of the Russian Federation". Clause 15 of the article 38 states: “It is prohibited to manufacture: 1) medical devices not included in the state register of medical devices and organizations (including private entrepreneurs) engaged in the production and manufacture of medical devices, with the exception of medical devices produced for testing and (or) research; 2) counterfeit medical products".
Thus, the 323rd Federal Act prohibits the production of medical devices if they are not included in the state register of medical devices. The wording of the prohibition is especially important: it is not advertising/sale / use that is prohibited, but the entire turnover, including production.
The only exception is the Resolution of the Government of the Russian Federation No. 1335 "On Amending Clause 2 of the Rules for State Registration of Medical Devices" of January 09, 2020: medical devices intended for use on the territory of the international medical cluster or on the territories of innovative research and technology centers are exempted from registration.
Violation of the ban on the production, as well as the use of unregistered medical products, is administratively finalised and criminally prosecuted.
According to the Article 6.28 of the Code of administrative violations: “Violation of the established rules in the field of circulation of medical devices, if these actions do not contain signs of a criminal offence, entails the imposition of an administrative fine on citizens in the amount of two thousand to four thousand rubles; for officials, the fine is from five thousand to ten thousand rubles; for legal entities the fine is from thirty thousand to fifty thousand rubles."
Article 238.1 of the Criminal Code gives an explanation of a criminal offence: “Production, sale or import of counterfeit medicines or medical devices on the territory of the Russian Federation; or the sale or import of low-quality medicines or medical devices on the territory of the Russian Federation; or illegal production, sale or import of unregistered medicines or medical devices for the purpose of marketing on the territory of the Russian Federation; or production, sale or import of counterfeit dietary supplements containing pharmaceutical substances not declared at state registration on the territory of the Russian Federation; all committed on a major scale." According to clause 2 of this article: "By major scale in this article is meant the cost of medicines, medical devices or dietary supplements in an amount exceeding one hundred thousand rubles."
In other words, if a medical device developer sold their solution for over 100 thousand rubles, it is a criminal offence, if less, it is an administrative offence. The Criminal Code provides for the following punishment:
- If it is the sale of an unregistered medical device: correctional labour from 3 to 5 years, or imprisonment from 3 to 5 years with a fine from 500 thousand rubles up to 2 million rubles.
- If it was done by a group of persons by prior conspiracy; or by an organized group; or such a medical device resulted in the inflicting grievous bodily harm or death of a person, then imprisonment for a period of 5 to 8 years with a fine from 1 million rubles up to 3 million rubles.
- If the same has resulted in the death of 2 or more persons by negligence, then imprisonment for a period of 8 to 12 years with a fine from 2 to 5 million rubles.
The practice of criminal prosecution for the sale of unregistered medical software exists in our country already. What is more, prosecution after registration, for the previous sale of the unregistered medical device exists as well.
The state control over the circulation of medical devices is carried out by the Federal Service for Surveillance in Healthcare (Roszdravnadzor), https://roszdravnadzor.ru/. The procedure for such control is established by Order of Roszdravnadzor of December 09, 2019 No. 9260 "On Approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for the Implementation of State Control over the Circulation of Medical Devices."
The rules for registration of any medical devices, in accordance with clause 10 of the article 38 of Federal Act No. 323, are determined by the Government of the Russian Federation. The government determined these rules by the Resolution No. 1416 of December 27, 2012 "On Approval of the Rules for State Registration of Medical Devices". Clause 3 of this document establishes that the state registration of medical devices is carried out by Roszdravnadzor. The clause 5 states that state registration is carried out "... on the basis of the results of performance testing, toxicological studies, clinical trials, which are all forms of conformity assessment of medical devices, considering the classification depending on the potential risk of their use, and examination of the quality, effectiveness and safety of medical devices and taking into account the classification depending on the potential risk of their use ... ".
The rules for the classification of 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 June 06, 2012 No. 4n "On approval of the nomenclature classification of medical devices". At the same time, a separate section of the nomenclature classification, dedicated to the classification of software as a medical device, depending on the potential risk of its use was introduced by the order of the Ministry of Health of the Russian Federation of July 07, 1020 No. 686n.
After Roszdravnadzor has completed the registration procedure of a medical device, the developer is issued an appropriate document confirming the fact of state registration: a medical device registration certificate. The form of the document was approved by the Order of Roszdravnadzor No. 40-Pr/13.
Registration procedure
The process of preparing and registering software as a medical device from the point of a developer can be divided into 3 steps:
Stage 1. Preparation
At the first preparatory stage, the software developer needs to answer 2 main questions:
- Is your software product a medical device or not?
- If it is, what class of potential risk does it correspond to? This must be determined initially since the particularities of the following stages will depend on the determined risk class.
Question 1. Is the MD software or not?
The criteria for classifying software as a medical device are currently defined by the Roszdravnadzor information letter of February 13, 2020 No. 02I-297/20. According to this letter, the software is a medical device if 4 criteria are present:
- Software is a computer program or its part, regardless of the hardware platform and mode of delivery of the software
- The software is not a part of another medical device
- The software is intended to provide medical care by the developer
- The result of the software operation is automatic interpretation, including the use of artificial intelligence, and this result influences clinical decision-making.
When applying this letter and the provided criteria, the most important thing is the understanding that all 4 criteria must be valid for some software product - only in this case such a product is a medical device. If at least one of the criteria is irrelevant for some software solution, it automatically cannot be recognized as a medical device and, therefore, is exempted from the need for state registration until it is brought to the market.
Clarifications:
- The first point means that any software can be a medical device, it does not matter what hardware does it require and how it is delivered to the user. This means that such types of software as cloud services, microservices, embedded components (plugins, etc.) can be medical devices.
- The second means that the software is not developed specifically for some hardware medical device and is not a part of it. It should be versatile and work on any equipment without connecting any specific medical devices. If such software is intended for a piece of specific medical equipment, then it should not be considered as special software as it is checked and registered together with the hardware medical device.
- The third means that only software that the manufacturer has deliberately intended for use in the provision of medical care can be a medical device. If a manufacturer has released software for use in medical organizations, but not for medical purposes, this is not a medical device. This means that all accounting software, solutions in the field of medical statistics, administration of medical equipment, etc., are not MD.
- The most essential point is the fourth one. It means the following: software that does not significantly process information, does not change it in any way, and thus does not create an additional risk of causing harm to patient's health in the case of using such software cannot be MD. If the software simply accepts, stores and transmits medical information “as is”, even it is applied in medical care, such software is not MD. For instance, systems for maintaining electronic health records, systems for exchanging and storing medical images, etc. are not MD. If the software does not only accept, but then changes medical information, i.e. carries out its machine interpretation in such a way that the results of this interpretation can influence the clinical decision this is definitely MD. This includes all clinical decision support systems, complex laboratory systems, etc.
Thus, the first thing a software manufacturer should do is to carefully study the information letter of Roszdravnadzor, the criteria presented in it and examples of software being or not being MD and then make a decision about its own product, whether it meets all these criteria? It is not an easy question. As an additional unofficial criterion, we propose to answer the following question: if the software will be used in the provision of medical care and there will be some kind of error/failure or something unforeseen (even purely theoretically), then as a result of this error, can a doctor make the wrong decision and harm the patient's health? If the answer is yes, you should take another careful look at the criteria, as most likely this software is a medical device.
We recommend you to discuss this matter with an experienced lawyer. If the answer unequivocally "yes", then you can immediately proceed to clarify the class of potential risk (next step).
If the developer does not think so or they have doubts (which happens often), then in both cases so far the only more or less reliable measure is to write an official appeal to Roszdravnadzor, in which you need to indicate what kind of software you are developing, what it is intended for and at least in general outline to present its most important functions. This norm is provided for in clause 6 of the decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 "On the Rules for registration and examination of the safety, quality and effectiveness of medical devices", according to which the applicant, if necessary, "... receives preliminary consultations from an expert organization on the registration and examination of medical products". In accordance with clause 1 of the "Regulations on the Federal Service for Surveillance in Healthcare", Roszdravnadzor, being a federal executive body exercising control and surveillance functions in this field, has the right to provide legal entities and individuals with explanations on issues within its competence.
According to Art. 12 of Federal Act No. 59, a written appeal received by a government body or an official in accordance with their competence is considered within 30 days from the date of registration of the written appeal. In exceptional cases, this can be extended, but the applicant must be notified first.
If you already have a similar experience, the writing of such a letter and its coordination with a lawyer can be done quickly, in 1 day. Since the law does not provide any possibility of contacting Roszdravnadzor via an electronic communication channel, therefore, a simple letter is sent by courier or "Russian Post". Shipping takes at least 1 day, or even 3 to 5 days. And then you wait for maximum of 1 month.
If you were told that your product is not MD, the procedure is over, you can skip further steps. If the answer says that your solution is, in fact, a MD, then let's move on.
Question 2. Which risk class is the software assign to?
After we have made sure that our software is a medical device, we need to understand what class of potential risk does your solution have? There will mainly be 2 answers: either class 1 (minimum risk), or 2a. In extreme cases, the class can be 3b. It is unlikely that now there will be massive production of software with higher risk classes (which is legally not excluded).
Unfortunately, there are still no solid and detailed documents to this question, with the help of which a reliable answer could be given. Currently, the development of separate criteria for classifying special software depending on risk classes is ongoing. Until they are approved, criteria from hardware MD should be used.
Stage 2. Tests and Trials
According to clause 5 of Resolution No. 1416 and Order of the Ministry of Health No. 737n, in order to undergo state registration, the developer (manufacturer) must submit the following documents to Roszdravnadzor:
a) Application in the form given in Appendix No. 1 to order 737n;
b) A copy of the document confirming the authority of the representative of the manufacturer;
c) Information about the regulatory documentation for the medical device;
d) Manufacturer's technical documentation for a medical device;
e) Operational documentation of the manufacturer for the medical device, including instructions for use or manual for the operation of the medical device;
f) Photographic images of the general view of the medical device, together with the accessories necessary for the intended use of the medical device (not less than 18 x 24 centimeters);
g) Documents confirming the results of performance testing of a medical device;
h) For medical devices of class 1 of the potential risk of use: documents confirming the clinical trial;
i) In case when a clinical trial requires human participation: a draft plan for clinical trials of a medical device with supporting materials;
j) Inventory of documents in accordance with Appendix No. 2 to order 737n.
Please note that in accordance with clause 25 of section III of the Order of the Ministry of Health No. 2 of September 1, 2014, toxicological tests are carried out only to products that, according to the manufacturer's documentation, come into contact with the human body when using MD. Now almost all software can be delivered via an electronic communication channel, including downloading from websites, which allows to avoid physical contact of a person with different CDs, boxes, flash drives and other media. Therefore, it is not necessary to submit documents confirming the results of toxicological studies for software.
What is more, it is not required to submit documents confirming the test results of a medical device in order to approve the type of measuring instruments as most likely it is not the case with a software medical device.
The requirements for the technical and operational documentation of the MD manufacturer are approved by the Order of the Ministry of Health No. 11n, which provides for a fairly large range of information that must be presented in the documents.
It will be very difficult to develop such documentation; it will in any case require significant time and experience in working with such documents. First, the developer must form the Technical Specifications, a special document that establishes the technical requirements that specific software must comply with. The document must comply with GOST 2.114-95. It should describe the procedures by which you can determine whether the prescribed requirements have been met as well.
Then, based on Technical Specifications, it is necessary to develop a block of documentation for the software product, and it must correspond to a large list of GOSTs, the bulk of which was created in the last century (see table below). The developer decides at his own risk whether to form this package of documents themselves or to involve a special organization in order to reduce the loss of time for correcting errors and do everything correctly the first time.
| Document no. | Document name |
| National State Standard (GOST) 21552-84 | Computer facilities. General technical requirements, acceptance, test methods, labelling, packaging, transportation and storage |
| Russian National Standard (GOST R) IEC 62304-2013 | Medical products. Software. Life cycle processes |
| GOST R ISO 15223-1-2014 | Medical products. Symbols used in marking on medical devices, labels and accompanying documents. Part 1. Basic requirements |
| GOST R 50444-92 | Medical devices, apparatus and equipment. General specifications |
| GOST R ISO/IEC 12119-2000 | Information technology. Software packages. Quality requirements and testing |
| GOST R ISO/IEC 9126-93 | Information technology. Evaluation of software products. Quality characteristics and guidelines for their application |
| GOST R ISO 9127-94 | Information processing systems. User documentation and packaging information for consumer software packages |
| GOST 28195-89 | Assessment of the quality of software. General Provisions |
| GOST R 51188-98 | Protection of information. Testing software for the presence of computer viruses. Model guide |
| Sanitary Regulations and Standards 2.1.7.2790-10 | Sanitary and Epidemiological Requirements for Medical Waste Management |
In our experience and the opinion of fellow developers, the creation of a set of documents can take from 1 to 2 months.
Next, you need to pass a series of tests:
- Carry out technical tests
- For software MDs of the risk class 1 the next step is to conduct clinical trials (for the risk class 2a, this is necessary as well, but after obtaining permission from Roszdravnadzor at the 3rd stage).
Technical and clinical trials are regulated by the Order of the Ministry of Health of Russia No. 2n of September 01, 2014.
According to clause 4 of the Registration Rules, approved by Resolution No. 1416, technical tests are carried out in order to determine the compliance of the characteristics of a medical device with the requirements of regulatory documents, technical and operational documentation of the manufacturer and to make a subsequent decision on the possibility of conducting clinical trials. The manufacturer himself determines which regulatory documents his product complies with.
A clinical trial is a systematic study designed and planned to evaluate the safety and efficacy of a medical device. Clinical trials can only be carried out if technical trials are successful.
Clinical trials with human participants will need to be carried out only in the cases specified in paragraph 37 of Section IV of the Order of the Ministry of Health No. 2, that is:
- If you have invented a truly innovative software product that no one has ever done (i.e., if there are no analogues)
- If you offer new complex or unique methods of prevention, diagnosis and treatment of diseases and medical conditions, or provide for the use of new complex medical technologies
- If during the research it was not possible to confirm the effectiveness and safety of the medical device.
We believe that human testing is redundant for most software products.
In other cases, clinical trials of medical devices may be carried out in the form of analysis and evaluation of clinical data. For this, a report is drawn up, which must contain clinical evidence of the effectiveness and safety of the medical device. It must comply with the accepted rules for conducting clinical trials of medical devices, prove the completeness of the studies performed, the reliability of the results and the comparison of clinical data with available analogues. It is on the basis of such a report that the expert institution of Roszdravnadzor should later recognize the research results as satisfactory.
The duration of clinical trials depends on the purpose and complexity of the medical device. The program of clinical trials is drawn up by the applicant together with the medical organization that carries out the trials, in accordance with the requirements specified in the manufacturer's technical and operational documentation, as well as the requirements of regulatory documents. If clinical trials are conducted with human participation, it is necessary to obtain an opinion on the ethical justification of its conduct from the Ethics Council for the Circulation of Medical Devices of the Ministry of Health.
If in the course of clinical trials, revealed inconsistencies of the software MD with the purpose and indications for use established by the manufacturer in the operational documentation or established facts and circumstances pose a threat to the life and health of citizens and medical workers during usage of a software product, then the results of the tests are negative. In other cases, the decision must be positive.
The results of the tests are acts developed on the basis of the samples approved by order of the Ministry of Health No. 2.
According to clause 4 of Order No. 2n, the manufacturer must independently determine a testing organization that will conduct technical tests as well as a medical organization that will perform clinical trials. Requirements for medical organizations conducting clinical trials are approved by the Order of the Ministry of Health of the Russian Federation of May 16, 2013 No. 300n (in Russian). The list of medical organizations that meet these requirements is available on the Roszdravnadzor website at http://www.roszdravnadzor.ru/services/test_clinical.
Thus, in order to conduct tests, the developer must choose one of the authorized organizations, enter into a contract with the organization, pay for the services and wait for implementation. The methodology for determining the amount of fees for examination and testing of medical devices is regulated by the Order of the Ministry of Health No. 1386n.
A list of preparatory activities and approximate duration of each of them are shown in the table below.
| No. | Event | Duration |
| 1 | Development of a set of technical and operational documentation | Not regulated. It depends entirely on the developer. The less mature the product / IT company will apply for registration, the longer and more difficult this stage is. |
| 2 | Conclusion of an agreement between the developer of the software MD and the organization that carries out testing and finalization of documents | Not regulated. From our experience, it takes from several days to 2-3 weeks. |
| 3 | Conducting performing testing | Not more than 30 working days from the date of submission of the MD sample and documentation to the testing organization. By agreement with the applicant, it can be extended, but for no more than 12 working days. Clause 10 of Section II of the Order of the Ministry of Health No. 2n |
| 4 | Obtaining an opinion from the Ethics Council in the field of circulation of medical devices of the Ministry of Health on the ethical justification of conducting clinical trials | Required only for software MD of the risk class 1 and only if human clinical trials are underway. No more than 30 working days from the submission of the document (Paragraph 40 of section IV of the Order of the Ministry of Health No. 2. |
| 5 | Clinical trials | Required only for software medical device risk class 1. According to Clause 39 of section IV of the Order of the Ministry of Health No. 2, the duration is not limited. From our experience, it takes several months. |
| 6 | Registration of an application for state registration and a package of accompanying documents | If it is done very quickly, then it takes 1 day. |
| 7 | Payment of the state registration fee | It can be done simultaneously with the previous stage. |
Thus, if a software MD is declared for the 1st minimum risk class, then the preparatory stage can take from 3 to 6 months or even more. If the risk class is 2a, then the procedure can be significantly accelerated, as in this case clinical trials of a software MD will be carried out at the 3rd stage after submitting an application for registration with Roszdravnazdor.
The most difficult at the test stage:
1. Prepare all the complete technical and operational documentation correctly. Any errors will be the basis for suspension of state registration and the return of documents for revision by the applicant.
2. Conduct technical tests and draw up all the documents correctly.
3. Develop a methodology and conduct clinical trials, as well as draw up a high-quality protocol for evaluating the results of clinical trials of a medical device.
Stage 3. Registration (Approval)
The registration process includes the acceptance and verification of documents for the completeness and reliability of the information specified by the applicant, and the following an examination of quality, efficiency and safety.
The duration depends on the class of potential risk indicated by the applicant in the documents. According to the Decree of the Government of the Russian Federation of May 31, 2018 No. 633 "On changes in the procedure for state registration of medical devices", the period for state registration of medical devices of the 1st (minimum) class of potential risk of use was reduced by 20 working days due to the examination of quality, efficiency and safety in one step without the need for prior approval to conduct clinical trials.
The examination of the quality, effectiveness and safety of a medical device is carried out by an expert institution subordinate to Roszdravnadzor: FSBI VNIIIMT (Federal State Budget Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service for Supervision in the sphere of public health) or FSBI CMIKEE (Center for Monitoring and Clinical and Economic Expertise of the RF Service for Supervision in Health Care). Their operation was approved by the Order of the Ministry of Health of the Russian Federation of December 21, 2012 N 1353n "On approval of the procedure for organizing and conducting an examination of the quality, effectiveness and safety of medical devices." In addition, the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 "On the Rules for registration and examination of the safety, quality and effectiveness of medical devices" is in force.
In addition to this regulatory act, there are general guidelines for the examination of quality, efficiency and safety, developed by the relevant institutions and approved in 2016. For software, Roszdravnadzor and FSBI VNIIIMT developed and approved a separate document in August 2018: “Methodological recommendations on the procedure for the examination of the quality, efficiency and safety of medical devices (in terms of software) for state registration within the framework of the national system”.
After successful registration, information about the developer and the medical device is placed in the State register of medical devices and organizations (private entrepreneurs) manufacturing medical devices (hereinafter “the State Register”). The rules for its maintenance were approved by the Decree of the Government of the Russian Federation of June 19, 2012 No. 615 "On approval of the Rules for maintaining the state register of medical devices and organizations engaged in the production and manufacture of medical devices." The register itself is available on the Roszdravnadzor website at http://www.roszdravnadzor.ru/services/misearch/.
The list of measures for state registration and approximate duration of each of them for software MDs of the 1st (minimum) risk class is given in the table below.
| № | Event | Duration |
| 1 | Registration of documents received from the applicant | 1 business day from the date of receipt (Government Decree No. 1416) |
| 2 | Checking the completeness and accuracy of the provided information | 5 business days from the date of receipt of the application (Clause 15 of the Government Decree No. 1416) |
| 3 | Applicant eliminates any drawbacks if they were identified at the previous stage | No more than 30 business days (Clause 16 Government Decree No. 1416) |
| 4 | The decision on the beginning of state registration | 3 business days from the date of receipt of duly executed documents (i.e. checked for completeness and accuracy; Clause 17 of Government Decree No. 1416) |
| 5 | Execution of an assignment for an examination of the quality, effectiveness and safety of a medical device by Roszdravnadzor and its transfer to an expert institution | 3 business days from the date of the decision on the beginning of state registration (Paragraph 20 of the Government Decree No. 1416) |
| 6 | Examination of quality, efficiency and safety by an expert institution, in one step | 20 business days from the date of receipt of the assignment from Roszdravnadzor (Government Decree No. 633 and Paragraph 22 of the Government Decree No. 1416) |
| 7 | In case of insufficient materials and information for the expert to make a conclusion, the applicant provides additional information upon request | 2 business days to transfer the request to the applicant from the moment the request is sent by the expert. No more than 50 business days for a response to the applicant. 2 business days for the transmission of the answer from the applicant to the expert (Clause 21.1 of the Government Decree No. 1416) These terms are not included in the general term of the examination; therefore, they lengthen the entire procedure. |
| 8 | Making a decision on state registration of MD or refusal on the basis of an opinion received from an expert institution | No more than 10 business days from the date of receipt of the opinion from the expert institution (Paragraph 4 of the Government Decree No. 1416) |
| 9 | Placement of information in the State Register | 1 business day (Clause 8 of the Rules for maintaining the Register, Resolution No. 615) |
The list of measures for state registration and approximate duration of each of them for software MDs of risk class 2a (and higher) is given in the table below.
| No. | Event | Duration |
| 1 | Registration of documents received from the applicant | 1 business day from the date of receipt (Government Decree No. 1416) |
| 2 | Checking the completeness and accuracy of the provided information | 5 business days from the date of receipt of the application (Clause 15 of the Government Decree No. 1416) |
| 3 | Applicant eliminates any drawbacks, if they were identified at the previous stage | No more than 30 business days (Clause 16 Government Decree No. 1416) |
| 4 | Decision on the beginning of state registration | 3 business days from the date of receipt of duly executed documents (i.e. checked for completeness and accuracy; Clause 17 of Government Decree No. 1416) |
| 5 | Execution of an assignment for an examination of the quality, effectiveness and safety of a medical device by Roszdravnadzor and its transfer to an expert institution | 3 business days from the date of the decision on the beginning of state registration (Paragraph 20 of the Government Decree No. 1416) |
| 6 | Conducting the 1st stage of quality, efficacy and safety examination by an expert institution: making a decision to conduct a clinical trial | 50 business days from the date of receipt of the assignment (Clause 19 of the Government Decree No. 1416) |
| 7 | In case of insufficient materials and information for the expert to make a conclusion, the applicant provides additional information upon request | 2 business days to transfer the request to the applicant from the moment the request is sent by the expert. No more than 50 business days for a response to the applicant. 2 business days for the transmission of the answer from the applicant to the expert (Clause 21.1 of the Government Decree No. 1416) These terms are not included in the general term of the examination; therefore, they lengthen the entire procedure. |
| 8 | Obtaining an opinion on the ethical justification of conducting clinical trials from the Ethics Council in the field of circulation of medical devices of the Ministry of Health | Only if human clinical trials are being conducted. No more than 30 business days from the submission of the document (Paragraph 40 of section IV of the order of the Ministry of Health No. 2) |
| 9 | Processing of a conclusion on the possibility of conducting a clinical trial received by Roszdravnadzor from an expert institution | 5 business days from the date of receipt of the conclusion of the expert organization (Paragraph 24 of the Government Decree No. 1416) |
| 10 | Conducting clinical trials based on permission from Roszdravnadzor and an opinion on ethical justification | According to Clause 39 of section IV of the Order of the Ministry of Health No. 2, the duration is not limited. From experience, it may take several months. |
| A decision to resume state registration after receiving information about the completion of clinical trials from the applicant | Within 2 business days after receiving the application (Clause 31 of the Government Decree No. 1416) | |
| 12 | Sending to the expert institution the results of clinical trials of a medical device submitted by the applicant | 2 business days from the date of the decision to resume (Clause 32 of the Government Decree No. 1416) |
| 13 | Conducting the 2nd stage of the examination of the quality, effectiveness and safety of a medical device by an expert organization: examination of the completeness of the results of clinical trials | 10 business days from the date of receipt of documents from Roszdravnadzor (Clause 33 of the Government Decree No. 1416) |
| 14 | Making a decision on state registration of MD or refusal on the basis of an opinion received from an expert institution | Not more than 10 business days from the date of receipt of the opinion from the expert institution (Paragraph 4 of the Government Decree No. 1416). |
| 15 | Placement of information in the State Register | 1 business day (Clause 8 of the Rules for maintaining the Register, Resolution No. 615; Clause 36 of the Government Resolution No. 1416) |
Thus, if we assume that the applicant completed all the documents correctly on the first attempt and Roszdravnadzor and the expert institution did not have any comments and requests for additional information, we have calculated the following duration:
- For medical devices of the 1st class of potential risk: from the moment of filing in an application with Roszdravnadzor to the registration of the solution in the state register: at least 40 days
- For medical devices of 2a class of potential risk and above: at least 87 days + the time of clinical trials, the duration of which is not regulated.
Let us pay special attention to the fact that the duration of this stage directly depends on the quality and completeness of the issued documents and testing. Because it is very difficult to predict what should be written in a particular document and how exactly it is assessed by the relevant experts, it is impossible to guarantee that the above time limits will be universally respected. According to the accumulated practice of the developers of medical software, sometimes the documents are returned to the applicant for revision and clarification during registration. That is why the registration process can be quite long-lasting. To avoid this, it is necessary to work out the documents with very high quality, if possible, consulting the relevant experts and companies who have already experienced such registration.
Please note that the above terms are the terms of registration only. Let's not forget about the preparatory stage of technical testing and documentation preparation, which was described by us above.
Conclusion
Preparation of documents, testing and registration is a complex and time-consuming process. Despite the presence of some time frame for individual procedures, the duration of the entire process primarily depends on the developer themselves.
If everything is done strictly by the book and all the necessary documents are prepared correctly from the first attempt, then the duration of the preparation and registration of software as MD are as follows:
| Stage | Risk Class 1 | Risk Class 2a |
|---|---|---|
| Regulatory framework research, specification of criteria | At least a few days, in reality about 1 month. | |
| Preparation of documents (Technical Specifications, etc.) | From 1 month and longer | |
| Tests and Trials | From 3 to 6 months | From 1 month |
| Registration | In accordance with the law, no less than 40 days | In accordance with the law, no less than 87 days |
| Total (approximate) | From 3 to 9 months | From 8 months to 2 years |
The reason for the complexity of state registration of medical devices is that, in addition to the operation of Roszdravnadzor, which is indeed quite fast and transparent from the regulation point of view, preparatory and intermediate stages, especially clinical trials, are carried out by special organizations and are complex and lengthy. It is these trials who make the main contribution to the delay in the preparation process for registration.