Circulation of medical items in Russia
Firstly, let’s say what is considered to be medical items in Russia. Those are any tools, apparatus, instruments, equipment, materials and other products used for medical purposes, alone or in combination with each other, and also together with other accessories necessary for the use of these products for the intended purpose, including special software, and intended by the manufacturer (producer) for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of a human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions of a body, preventing or terminating pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on a human body.
Medical items made according to individual orders of patients, which are subject to special requirements for prescription by medical professionals and which are intended solely for personal use by a specific patient, are not subject to state registration.
In this article we will talk about documents required for the legal circulation of medical items in Russia and some features of their design.
The circulation of medical items includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their state registration, production, manufacture, import into the Russian Federation, export from the Russian Federation, confirmation of compliance, state control, storage, transportation, sale, installation, commissioning, application, operation, including maintenance, prescribed normative, technical and (or) operational documentation the manufacturer (manufacturer), as well as repair, recycling or destruction.
For legal circulation of medical items in Russia mostly needs two obligatory documents – Registration certificate and Declaration of conformity. For some medical items instead of Declaration should be made Certificate of conformity. Compulsoriness of a Declaration and a Certificate is determined for specific types of goods based on the Government Decree. Most medical items require a declaration procedure.
The main procedure is the registration of medical items, as a result of which the Federal Service draws up a Registration certificate. Registration of medical products is a state procedure, the purpose of which is to allow the release of high-quality and safe products to the Russian market.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) performs State registration of medical products.
A Registration Certificate for a medical item is a document confirming the fact of the of a medical item`s state registration.
Federal Law No. 532-FZ dated December 31, 2014 provides for administrative and criminal liability for illegal manufacture of medical products, circulation of falsified, poor-quality, counterfeit and unregistered medical products, falsification of documents for medical products or their packaging.
Below you could see common strategy for medical items State registration
The first step for this process is the Manufacturer’s decision on the name, purpose and variability of the product’s delivery set.
Next step will be selection of the necessary documents and their certification by the official body of Manufacturer`s country, receipt of documents from the Manufacturer, their translation and notarization in Russia.
State registration of medical products is performed on the basis of the results of technical tests, toxicological studies, clinical trials, which are forms of conformity assessment of medical products taking into account the classification, depending on the potential risk of their use, and quality, effectiveness and safety examination of medical products, taking into account the classification depending the potential risk of their use, as well as tests to validate the type of measuring devices (with regard to medical products relating to measuring devices in the field of state regulation of ensuring measurements uniformity, a list of which is approved by the Ministry of Healthcare of the Russian Federation).
For purpose of tests must be made Permit for import medical items to Russia. The number of medical items for testing is determined based on the specifics of the product.
At the preliminary stage of registration, the conformity assessment of the medical item held in the form of toxicological and technical tests. For in vitro items of any risk class and any items of risk class 1, clinical (clinical and laboratory) tests are also carried out at this stage.
A registration file includes Manufacturer`s documents, test reports, photos of medical items, application, regulatory information and some accompanying documents. Above mentioned documents should be submit to Roszdravnadzor. Within 3 business days from the date of the submission of a duly executed application for registration, the registration authority decides to start state registration of medical items.
Roszdravnadzor draws up and issues a task for the examination of the quality, effectiveness and safety of the medical item to the Federal state budgetary institution under the jurisdiction of the registration authority (hereinafter – the expert institution).
An examination of the quality, effectiveness and safety of medical products is provided by an expert institution in accordance with the procedure approved by the Ministry of Health of the Russian Federation:
a) at the first stage, an examination of registration applications is carried out to determine the possibilities (impossibility) of conducting clinical trials of medical items (with the exception of medical items of the 1st class of potential use and medical items for in vitro diagnostics);
b) at stage II, an examination is carried out of the completeness and results of technical tests, toxicological studies, clinical trials, as well as tests in order to approve the type of measuring instruments (for medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved The Ministry of Health of the Russian Federation).
If it is insufficient for the expert to make the conclusion of the materials and information contained in the registration application submitted by the applicant, the expert raises the question of providing him with the necessary materials and information.
The applicant must submit a response to the request of the registering authority within a period not exceeding 50 business days from the date of receipt of this request.
The basis for making a decision on the refusal of state registration is the receipt by the registering body of an expert institution of a conclusion on the impossibility of conducting clinical trials of a medical item.
Clinical trials of a medical item, with the exception of medical items of the 1st class of potential risk of use and medical items for in vitro diagnostics, are carried out on the basis of permission for conducting clinical trials issued by the registering authority.
At the end of clinical trials of a medical item, the applicant submits to the registering authority an application to renew state registration of the medical item and the results of clinical trials of the medical item.
At the II stage of the examination of the quality, effectiveness and safety of a medical item, the registering body, within 2 business days from the date of the decision to renew the state registration of the medical item on the basis of the task to conduct an examination of the quality, effectiveness and safety of the medical device, sends the clinical results submitted by the applicant to the expert institution testing a medical item.
The grounds for a decision by the registration authority to refuse state registration of a medical device are:
a) receipt of an opinion from an expert institution on the results of an examination of the quality, effectiveness and safety of a medical device, indicating that the quality, and (or) effectiveness, and (or) safety of the registered medical device are not confirmed by the data received, and (or) that the risk of harm to the health of citizens and medical workers due to the use of a medical device exceeds the efficiency of its use;
b) the registration authority identifies, according to the results of state control over the circulation of medical items, inconsistencies of data on the effectiveness and safety of the medical item with data on the medical item contained in the application for registration and documents.
Within 1 business day after a decision is made on the state registration of a medical item, the registering authority enters data on the registered medical item in the state register.
The Declaration of conformity is executed after State registration in a much shorter time. It takes usually about 1 – 3 weeks to make Declaration. Time depends on tests required for this process.
Until December 31, 2021, at the choice of the manufacturer of the medical item or its authorized representative, registration of the medical item may be carried out in the manner established by the Commission (according EAEU rules), or in the national manner.
In the next articles we will talk about introduction of changes to the documents contained in the registration dossier according Russian rules and the features of the circulation of medical items in the EAEU.
We will be happy to provide you with all the necessary clarifications and answer all your questions.