- 1- Вы задавались вопросами:
- 21. «Можно ли, внести изменения в РУ 2006 г.?»
- 22. «Требуется ли, переоформление РУ при смене организационной формы?»
- 23. «Как присвоить вид медицинского изделия в соответствии с Приказом № 4н от 06.06.2012 г.?
To include products developed for medical purposes in the unified register, it is necessary to carry out the relevant preliminary studies, the requirements for which are stipulated in terms of legislation. Therefore, all medical products, for the first time entering the Russian market, should be tested by independent laboratories, tested for biological and mechanical harmlessness. Registration of permits provides for the organization and implementation of toxicological, technical testing and clinical trials.
The Common Technical Document includes protocols of toxicology and technology, but this regulation applies only to medical products of 2a, 2b and 3 risk classes. For all other medical products there is a simplified registration procedure. Clinical trials for them are carried out directly, without obtaining permission from the registering authority. Thereafter, the research protocol obtained shall be attached to the other previously collected materials, before submission to Federal Service of Russia for the Oversight of Public Health and Social Development (Roszdravnadzor).
Toxicological tests are performed first. Also, they can be performed alongside with the technical tests, provided that each laboratory will be provided with samples of products with different serial numbers or Lots.
As for the foreign manufacturers, prior to these measures, they are obliged to receive from the supervisory authority a permission to import samples of medical products.
Conditions for performing toxicological tests
These tests help to detect the presence or absence of harmful toxic effects on the patient, provoked by a chemical reagent. The reasonability of their implementation is determined by the obligatory contact with the human body (with body surface, for implantation, with temporary introduction from the outside into the body). In this case, contact with body may be short-term (up to 1 day), or permanent (up to 2 or more days) and carried out directly or indirectly (with biological medium, wounds and abrasions, skin and mucous membranes).
In particular, toxicological tests of medical device allow to confirm its biological compatibility with a human body, and also harmlessness of effect on it.
According to statistics, these studies, as well as technical tests, take no more than 30 days from the date of submission of the relevant set of materials to the Roszdravnadzor, including the sample itself with the approved program of experiments, but with the consent of the applicant, the period may be extended for another 20 days.
If the medical device is produced for single use, and is sterile, then the additional tests are necessary to confirm these facts.
Recommendations of our specialists
It is better to start these experiments when you have already prepared the registration statement and the full set of registration documentation. Since any adjustments in the technical documents require the correction of relevant information in the protocols, and this can lead to a data collision at the consideration process in the Roszdravnadzor!
The cost of the service is 90,000 rubles. Term is 21 days.
What is the need for technical testing of medical devices?
The above tests allow to determine the correctness of the generated technical description, in particular, to what extent it meets the requirements of the Russian legislation. They are carried out through actual revisions, and also provide for the evaluation of data analysis for quality control, absence of harm of the device at its use.
Medical device research is carried out in the form of verification for electrical safety, as well as for electromagnetic compatibility (EMC), and often take place in different laboratories, each of which draws up a separate protocol.
Recommendations of our specialists
for a valid certificate and a scope of accreditation from the laboratory where you will conduct these tests.
The cost of trials is 90 000 rubles. Term is 21 days.
When do clinical trials of medical devices begin?
As it is known, the procedure for obtaining permits is quite complicated. It provides for the certain stages, each of which has requirements from the domestic legislation, including international standards.
So, when do clinical trials of medical devices begin? The answer to this question is ambiguous. In order to understand the need for these experiments, it is first necessary to determine the risk class of the medical device. After all, it depends on the time of these studies to be implemented.
Thus, if the medical device refers to the 1st class of risk, then it is subject to the clinical trials at the first stage of the registration procedure.
If the medical device refers to the 2nd (a,b) and 3rd risk classes, then they are subject to the clinical trials only after obtaining of a positive result at the 1st stage of the examination of quality and safety, as well as obtaining a permit from Roszdravnadzor for carrying out such trials.
Not taking into account the fact that medical organizations have been carrying out these activities for many years, the established practice of their conduct, based on international standards, is just beginning to generate. For clinical trials, the applicant has the opportunity to choose a medical organization, where to conduct them. After obtaining the appropriate permission from Roszdravnadzor, it is necessary within 5 working days to send here the information about the place and start date of clinical trials. In addition, after the suspension of the state registration procedure, it is required to decide the form of clinical trials.
If human involvement is not required in clinical experiments, such studies shall be conducted in the form of analysis as well as evaluation of clinical data provided by the applicant.
Human participation is necessary in the following cases:
What does a clinical trial program consist of?
Clinical trial program
Shall be compiled by the applicant together with the medical organization
Shall be approved by the head of the medical organization
The positive opinion of the Council of Ethics shall authorize you to conduct clinical trials of medicinal
In the case of human trials, the approved program shall be sent by the applicant to the Council of Ethics,
The Council of Ethics shall issue an opinion within 30 working days
Clinical trials of a medical device
When conducting clinical trials with the patient, the patient's condition and the medical device's operation shall be constantly monitored.
If suddenly the medical device fails or the patient's condition worsens, the studies shall be suspended or stopped until the fact-finding.
Cases of negative clinical results
Non-compliance of the medical device with the purpose and indications for use according to the operational documentation
Side effects, identified and not specified in the instructions for use, as well as adverse reactions
Circumstances that pose a threat to life and health in the use of medical device, as well as in operation
What do you need for successfull clinical trials?
Firstly, it is important to properly prepare a clinical dossier, which will include the application and all registration documents submitted to the Roszdravnadzor!
Secondly, the presence of evidence-based clinical data on a similar medical device!
Thirdly, the preparation of reviews and articles on the application of the product in medical practice!
It happens that the applicant makes unforgivable mistakes, when he indicates inaccuracy information about significant incidents and make a number of other inaccuracies, which in turn effects on the results of clinical trials (photo with a wry face)
Our experts are aware of all the aspects of this procedure and are ready to share their experience (link to the page "Experience for sharing!"), or provide competent support in its implementation.
Trust our experts -
Their long-term experience allows to overcome all difficulties!
We will promptly prepare a clinical dossier, form an evidence base, if necessary, we will help you to find reviews and articles on the analog, deliver samples to the laboratory, provide support in the process of clinical trials - until you obtain the protocols on hands (with a properly prepared dossier, it can be obtained in 2 weeks (trials without human) and safely continue the registration process!)
The cost of this service is agreed individually and depends on the specificity of the medical device.
See the cost of services