In order to pass the first stage of registration of a medical device under the EAEU rules, 5 steps are required to make:
Step No. 1. Determine the Risk Class of the Medical Device and its Nomenclature Classification by Type
Depending on some certain features, medical devices are categorized into four categories of potential risk of use: low – class 1, medium – class 2a, elevated – class 2b and high – class 3. (The rules are regulated by the Resolution of the Board No. 173 dated 22.12.15). According to the established norms, a single certificate may include several modifications of the same medical device (the Resolution on inclusion is taken by a special commission).
Step No.2. Determine the set of Documents of the Registration Dossier
The list of documents required for the registration dossier during the registration and expertise procedure for a medical device depends on the class of the potential risk associated with the use of the medical device. The set of documents includes:
- Applications for expert examination and registration of a medical device;
- A copy of the power of attorney from the manufacturer for the right to represent interests during registration;
- Copy of the authorization document to manufacture the specified medical device in the territory where the manufacturer is located;
- Copies of certificates confirming quality (ISO 13485 or the relevant regional or national standard of the Member State);
- Documents confirming the effectiveness of medical devices supplied to the EAEU (regional authorization documents can be provided);
- Copy of the registration document granting the right to international trade, which is issued by a member of the EAEU;
- Copy of the authorization document granting the right to international trade in the manufacturing country with an attachment;
- Reports detailing the features, scope of use, and technical information of medical devices;
- A certificate describing the features of the labelling and method of packaging drawn up in the national language;
- Information on production process, regulated quality control;
- Lease agreement (certificate of ownership) or other document confirming the possibility to carry out production at the declared address;
- Marketing information (only relevant if the product has been on the market for more than two years);
- A list with a detailed description of all accidents, unforeseen situations including a description of all measures taken to prevent side effects and correct errors made during production or use (information is not provided for newly developed and designed medical devices);
- A list of all standards that a medical device must comply with;
- A report confirming that the product is suitable for its medical purpose;
- A document that specifies the requirements for technical data;
- Records of all studies conducted and their results;
- Records of expert examination, study of biological impact and effectiveness for the purpose of assessing the biological effect of a medical device (these tests are carried out in relation to medical devices and (or) accessories to them that come into contact with the surface of the human body, its mucous membranes, and the internal environment of the body);
- Reports of trials in the clinical settings;
- Analysis of possible risks;
- Materials of all drug products included in the product;
- A report confirming the biological safety of a medical device;
- Report on possible sterilization (with a description of the research process);
- Data on the availability and functionality of software including existing licenses;
- Report on the necessary stability studies;
- Description of the operating process, method of application with images;
- Description of the maintenance process;
- Information on the inspection of the production process;
- Data on the collection of information on the safety and efficiency of use of medical devices after marketing.
Step No. 3: Collect data on the efficiency of use and safety of the product
The process is regulated by Resolution No. 27 dated June 12, 2016. In order to prepare the documents of the registration dossier and to confirm compliance with the general requirements of safety and efficacy of medical devices, the requirements for their labelling and operational documentation, the applicant shall test its medical device. The type of testing depends on the characteristics of the medical device.
According to the legislation of the EAEU, the following tests shall be carried out:
- Technical tests (in accordance with Resolution No. 28 dated June 12, 2016 this type of testing are not carried out for medical devices used for in vitro diagnostics);
- Toxicological tests for the purpose of assessing the biological effect of a medical device. These tests are carried out with respect to medical devices and (or) accessories to them that come into contact with the surface of the human body, its mucous membranes, and the internal environment of the body (tests are carried out in accordance with Resolution No. 38 dated June 16, 2016);
- Tests for the purpose of approving the type of measuring instruments, which are carried out in accordance with the Procedure for approving the type of measuring instruments. Tests in relation to medical devices classified as measuring instruments, the list of which was approved by the Resolution of the Council of the Eurasian Economic Commission dated 12.02.2016 No. 42 (implementation of examinations in clinical conditions are regulated by Resolution No. 29 dated February 12, 2016);
- Clinical trials (the applicant may also include available clinical data in the registration dossier).
All types of tests can be performed by the applicant in any institution included in the unified list of laboratories of the EAEU. Methods of performed activities and scope of work shall correspond to the type of medical devices.
Step No. 4: Select a Reference State and Concerned Member State
Clarification:
- A Reference State is the state through whose authorized body the medical device is registered;
- Concerned Member States are states that coordinate the expert opinions of the reference state. The choice of both belongs to the applicant.
Step No. 5. Pay the Fee for Expert Examination and Registration of the Medical Device
After the preparation of the registration dossier, the applicant shall pay the fee for the expert examination and registration of the medical device in the reference state. Fees for the expert examination and registration of the medical device in the Concerned Member States are paid after a positive decision on the registration of the medical device is adopted by the reference state.