Registration procedure for medical devices in Russia
For the circulation of medical devices in Russia, it is necessary to issue a Registration Certificate. A Registration Certificate for a medical item is a document confirming the fact of the of a medical device’s state registration. The Federal Service for Surveillance in Healthcare (Roszdravnadzor) performs State registration of medical products. 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. Let us inform you about the registration procedure of the Registration Certificate in Russia.
The registration procedure for a medical device includes documents preparation, technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their state registration, import into the Russian Federation. Let us explain each stage in detail.
Stage I. Documents preparation.
At this stage the manufacturer’s documents are gathered and technical and service documentation is finalized. The manufacturer’s documents are, in most cases, the four main documents, as follows:
- extract of registration of the manufacturer’s company,
- power of attorney from the manufacturer to an authorized representative,
- ISO 13485 Certificate,
- declaration of conformity of the medical device with the requirements of the Council Directive 93/42/EEC or 98/79/EEC.
These documents are legalized in three ways:
- – by Apostille or consular legalization in Europe or the USA,
- – by the Chamber of International Commerce (CCPIT) in China.
Documents with translation into Russian are submitted to Roszdravnadzor. The translator’s signature is certified by a notary.
Manufacturer’s technical documentation includes documents that regulate the build of a medical device, establish technical requirements and contain data for its development, production, application, operation, maintenance, repair, disposal or destruction.
Service documentation of the manufacturer includes documents that are intended to familiarize the consumer with the build of a medical device, regulate the conditions and rules of operation (use for its intended purpose, maintenance, current repair, storage and transportation), the values of the main parameters guaranteed by the manufacturer (producer), the characteristics (properties) of the medical device, warranty obligations, as well as information on its disposal or destruction.
Requirements for the content of technical and service documentation in Russia differ from the requirements for these documents in other countries. If these documents remain intact, Roszdravnadzor will issue a large number of comments or a refusal to register a medical device.
Let us list a few of these requirements:
- indications and contraindications for use of a medical product;
- description of the main functional elements of the medical product, which may be provided with diagrams, photographic images, figures, charts and other illustrations;
- description of components (units) of a medical product (if any);
- description of accessories, medical products or products that are not medical, but intended for use in combination with the stated medical product (if any);
- the list and description of the materials of a medical product making direct or indirect contact with the patient’s body (human body);
- data on marking of a medical product and its package;
- the list of risks identified in the risk assessment process and the description of these risks control method in order to reduce them to the tolerable level (if any);
- information on the verification and validation of a medical product that was used in order to prove the compliance of the medical product with the applicable requirements, including the results:
- information on the tests carried out, test reports, data analysis;
- information on the main design stages of medical products and information about the production processes, which may be provided with diagrams, photographic images, figures, charts and other illustrations;
- description of the sterilization method, information on validation methods concerning sterilization process (including bioburden tests, tests for pyrogenic agents availability, tests for residual quantity of sterilizing agent) and information on validation of the packaging process (if the medical product is delivered sterile);
- information on the process of design, engineering and validating of the software used in the finished medical product (upon the existence of software in the medical product that ensures its proper operation and (or) intended application);
- requirements for maintenance and repair of medical products;
- the procedure and circumstances for disposal or destruction of a medical product.
The more detailed information is provided by the manufacturer, the fewer comments there will be at the stage of checking the record files by experts.
Stage II: Importation of medical devices for testing.
To test medical devices, the manufacturer must submit samples of products to the test center. In order to import samples, the manufacturer’s representative draws up in Roszdravnadzor the Permit for the import of medical devices. This document is valid for 6 months. To obtain the Permit, the manufacturer provides his representative with information about the products: the names of the models, quantity, date of production, lots, storage life. Roszdravnadzor issues the Permit electronically within 5 working days. After obtaining the Permit, the Manufacturer forms a pro forma invoice for the import of samples and sends the products to his representative.
Stage III: Testing.
For the medical device’s state registration, it is necessary to conduct technical tests, toxicological studies, clinical trials, as well as tests in order to approve the type of measuring instruments in testing and medical centers of Russia.
Toxicological studies – are studies for assessing the biological safety of a medical device and making a subsequent decision on the possibility of conducting clinical trials.
Technical tests – are tests for determining the compliance of the characteristics (properties) of a medical device with the requirements of regulatory documentation, technical and service documentation of the manufacturer (producer) and deciding on the possibility of conducting clinical trials.
Clinical trials – is a developed and planned systematic study, which includes the participation of a person as a subject to assess the safety and efficacy of a medical device.
Stage IV: Collection of record files and submission to Roszdravnadzor.
Documents prepared in stages 1-3 are collected in the Registration Record Files. The dossier on behalf of the manufacturer is submitted to Roszdravnadzor by its Authorized Representative. The Authorized representative of the manufacturer is a legal entity or self-employed entrepreneur registered in the territory of the Russian Federation, authorized by the manufacturer (producer) of a medical device to represent his interests on the circulation of a medical device in the territory of the Russian Federation, including on issues of conformity assessment procedures and state registration, in the name of which a Registration Certificate for a medical device can be issued.
Stage V. Documentation expertise in Roszdravnadzor.
Roszdravnadzor checks the completeness and reliability of the information of the documents set that the Applicant submits for registration. If there are no comments at this stage, Roszdravnadzor sends the registration record files for examination.
The first stage is an examination to determine the possibility (impossibility) of conducting clinical trials.
At stage I, experts evaluate:
- completeness of documents,
- information about the medical device,
- information on regulatory documentation,
- technical documentation,
- service documentation,
- photographic images of appearance,
- the scope and completeness of the technical tests,
- the scope and completeness of toxicological studies,
- documents confirming the test results of the medical device for the purpose of type approval of measuring instruments,
- information on the permits issued by the registration authority for the import of medical devices for the purpose of their state registration,
Based on the results of the examination at Stage I, an expert opinion may be issued on the possibility or impossibility of conducting clinical trials. For medical devices of class 1 of potential risk of use and medical devices for in vitro diagnostics, the examination is carried out in one stage. For other products – in two stages and it is required to obtain a permit for clinical trials. If the expert opinion contains a conclusion that it is impossible to conduct clinical trials, Roszdravnadzor will issue a refusal to register a medical device.
At Stage II, the completeness and results of technical tests, toxicological studies, clinical trials, as well as tests for approving a type of measuring instruments are examined.
Grounds for Roszdravnadzor’s decision to refuse state registration of a medical device:
a) obtaining a conclusion from the expert institution that is based on the results of the examination that the quality, and (or) effectiveness, and (or) safety of the registered medical device are not confirmed by the data obtained, and (or) that the risk of harm to the health of citizens and health workers exceeds the effectiveness of the use of the medical device;
b) identification by Roszdravnadzor inconsistencies in data on the effectiveness, based on the results of state control over the circulation of medical devices, and safety of a medical device with data about a medical device, which are contained in the application for registration and documents.
Based on the results of the examination, Roszdravnadzor draws up a Registration Certificate or a notice of refusal to register a medical device. In case of refusal to register, it is possible to eliminate all comments on the examination, re-pay state fees, submit the record files again and get a positive result. The registration certificate allows to legally import medical devices into the territory of Russia, sell, transport, install, carry out maintenance, repair and dispose of them.