Registration of medical products in the Republic of Belarus
Pursuant to Resolution of the Council of Ministers of the Republic of Belarus No. 1269, state registration of medical products and medical equipment is a procedure for admission to production, realization and medical use of products for medical purposes and medical equipment manufactured in the Republic of Belarus or coming from outside the Republic of Belarus, which are recognized as complying with the safety, efficiency and quality requirements for human beings established in the Republic of Belarus.
Срок проведения первичной экспертизы документов не должен превышать 15 календарных дней.
Сроки проведения экспертизы медицинского изделия:
The authorized body in the territory of the Republic of Belarus to carry out expert work for the purposes of registration is RUE "Center for Expertise and Testing in Healthcare". Note that as part of the international forum "Circulation of Medical Products in Russia and EAEU" a Memorandum of Cooperation was signed between RUE "Center for Expertise and Testing in Healthcare" and Electrontest Group. The text of the Memorandum provides for cooperation in the field of expertise and quality of medical products, R&D, as well as the possibility of organizing training events on the circulation of medical products in the territory of the Union State and the EAEU.
At the moment, it is possible to obtain registration of a medical product for the purpose of its circulation in the territory of the Republic of Belarus under the following provisions:
- By Resolution of the Council of Ministers of the Republic of Belarus No. 1269 of 02.09.2008 "On State Registration (re-registration) of Medical Products and Medical Equipment";
- By Regulation No. 41 of 15.04.2009 "On Requirements to Documents Submitted for State Registration (Re-registration) of Medical Products and Medical Equipment" (as amended by Resolution No. 80 of 31.07.2019);
- By Resolution of the Ministry of Health of the Republic of Belarus No. 55 of April 23, 2015 "On a Set of Preliminary Technical Works Preceding State Registration of Medical Products".
1. Preparation of the Application and compilation of the Registration Dossier. Conclusion of the Agreement and payment to the settlement account of the state expert organization of the amount for expert examination. Submission of a set of documents to the authorized body.
2. Initial examination of documents. At this phase, the completeness, completeness and compliance of the documents of the Registration Dossier submitted by the applicant with the requirements of the current legislation with regard to the evidence of safety, quality and efficiency of the medical product are assessed.
3. Preliminary technical work required to confirm the safety, efficiency and quality of medical products and medical equipment.
2. Initial examination of documents. At this phase, the completeness, completeness and compliance of the documents of the Registration Dossier submitted by the applicant with the requirements of the current legislation with regard to the evidence of safety, quality and efficiency of the medical product are assessed.
3. Preliminary technical work required to confirm the safety, efficiency and quality of medical products and medical equipment.
Our task
Entrusting the task of registering your medical device to us, you can be sure that we will ensure successful registration throughout the EAEU: in the Republic of Kazakhstan, in the Russian Federation, in the Republic of Belarus, in the Kyrgyz Republic and in the Republic of Armenia.
We provide professional assistance in the development, correction and preparation of all necessary documents of the registration dossier, the main of which are:
- application for state registration of a medical device;
- information on regulatory documentation for the medical device;
- technical documentation of the manufacturer (producer) for the medical device (extract from the technical file/technical conditions, risk management file, manufacturer's reports, qualification test protocols);
- manufacturer's (manufacturer's) operational documentation for the medical device;
- documents confirming the results of technical tests of the medical device;
- documents confirming the results of toxicological tests of the medical device;
- documents confirming the results of medical device testing for the purposes of type approval of measuring instruments;
- documents confirming clinical effectiveness and safety of medical devices
- information on regulatory documentation for the medical device;
- technical documentation of the manufacturer (producer) for the medical device (extract from the technical file/technical conditions, risk management file, manufacturer's reports, qualification test protocols);
- manufacturer's (manufacturer's) operational documentation for the medical device;
- documents confirming the results of technical tests of the medical device;
- documents confirming the results of toxicological tests of the medical device;
- documents confirming the results of medical device testing for the purposes of type approval of measuring instruments;
- documents confirming clinical effectiveness and safety of medical devices
Electrontest Group of Companies includes its own testing facilities, namely: technical testing laboratory IL TSB LLC "Electrontest"; toxicological testing laboratory "ElectrontestBio", the main activity of which is testing of medical devices and drugs for biological safety, as well as clinical diagnostic laboratory accredited for technical, clinical and in vitro MI tests. Authorizations of all laboratories are confirmed by relevant documents. We guarantee that all tests, if necessary, will be carried out at the highest level, and the test results will be obtained in accordance with all necessary requirements and in a clearly defined time frame.
In its work, the company Electrontest LLP relies on many years of experience of its employees in the registration of medical products and in-depth familiarity with regulatory documents. We ensure a comprehensive approach to the registration procedure. If necessary, we, together with the testing centers of the Electrontest Group (www.electrontest-grp.ru), ensure the full range of medical product testing: technical, toxicological, clinical and clinical-laboratory testing of In Vitro products.
Срок действия регистрационного удостоверения: Бессрочно
Phases of Registration
You can save precious time and money by working with us, as we will undertake the preparation of all necessary documentation in accordance with the requirements of regulatory documents and regulatory bodies, as well as support the registration process after the submission of documents to the authorized body
В случае если по результатам первичной экспертизы документов имеются замечания, уполномоченный орган письменно уведомляет заявителя о необходимости их устранения в срок, не превышающий 45 календарных дней со дня уведомления. После устранения заявителем замечаний первичная экспертиза документов проводится повторно. Срок проведения повторной первичной экспертизы не должен превышать 10 календарных дней. В случае, если замечания не были устранены в срок, указанный в уведомлении, результат первичной экспертизы документов признается отрицательным.
Types of technical work to be performed if necessary:
I) If necessary, an inspection, which involves:
· Verification of the organization of input control of raw materials;
· Identification and traceability of medical products and medical equipment;
· Verification of the production process management of medical products and medical equipment;
· Verification of the control of inspection, measuring and testing equipment;
· Study of technological processes for the production of medical products and medical equipment, including verification of the availability of documents on the organization of the technological process;
· Study of methods of control and testing at all phases of production of medical products and medical equipment;
· Verification of storage conditions, types of packaging, labeling of medical products and medical equipment;
examination and assessment of the safety, quality and efficiency of medical products and medical equipment as well as their compliance with international standards and normative legal acts of the Republic of Belarus (for medical products and medical equipment manufactured overseas).
II) Sanitary and hygienic testing of medical products and medical equipment of domestic and foreign production for compliance with the requirements of sanitary norms and rules of the Republic of Belarus.
III) Technical testing conducted by accredited laboratories in accordance with the requirements of technical normative legal acts and/or technical normative legal acts of the manufacturer regulating technical, safety and quality requirements for medical products and medical equipment.
I) If necessary, an inspection, which involves:
· Verification of the organization of input control of raw materials;
· Identification and traceability of medical products and medical equipment;
· Verification of the production process management of medical products and medical equipment;
· Verification of the control of inspection, measuring and testing equipment;
· Study of technological processes for the production of medical products and medical equipment, including verification of the availability of documents on the organization of the technological process;
· Study of methods of control and testing at all phases of production of medical products and medical equipment;
· Verification of storage conditions, types of packaging, labeling of medical products and medical equipment;
examination and assessment of the safety, quality and efficiency of medical products and medical equipment as well as their compliance with international standards and normative legal acts of the Republic of Belarus (for medical products and medical equipment manufactured overseas).
II) Sanitary and hygienic testing of medical products and medical equipment of domestic and foreign production for compliance with the requirements of sanitary norms and rules of the Republic of Belarus.
III) Technical testing conducted by accredited laboratories in accordance with the requirements of technical normative legal acts and/or technical normative legal acts of the manufacturer regulating technical, safety and quality requirements for medical products and medical equipment.
Preliminary technical works shall be performed on the basis of the contract concluded between the authorized body and the applicant, and the term of their performance shall not exceed 150 calendar days from the date of its conclusion, except for the cases specified in parts two and three hereof.
By agreement of the Parties to the contract, the period of preliminary technical works may be extended up to 300 calendar days
By agreement of the Parties to the contract, the period of preliminary technical works may be extended up to 300 calendar days
4. Specialized examination of documents for medical products and medical equipment of foreign manufacture.
Specialized examination of documents provides for the assessment of the information contained in them for compliance with the requirements of efficiency, safety and quality, taking into account the peculiarities of the use of medical products and medical equipment in clinical practice.
The period of specialized examination of documents shall not exceed:
15 calendar days – for medical products;
20 calendar days – for medical equipmen.
If there are comments, the authorized body shall notify the applicant in writing of the need to eliminate them within a period not exceeding 30 calendar days.
After elimination of comments, a final specialized examination of documents shall be carried out, the term of which shall not exceed 10 calendar days – for medical products and not more than 15 calendar days – for medical equipment.
Specialized examination of documents provides for the assessment of the information contained in them for compliance with the requirements of efficiency, safety and quality, taking into account the peculiarities of the use of medical products and medical equipment in clinical practice.
The period of specialized examination of documents shall not exceed:
15 calendar days – for medical products;
20 calendar days – for medical equipmen.
If there are comments, the authorized body shall notify the applicant in writing of the need to eliminate them within a period not exceeding 30 calendar days.
After elimination of comments, a final specialized examination of documents shall be carried out, the term of which shall not exceed 10 calendar days – for medical products and not more than 15 calendar days – for medical equipment.
5. Clinical trials of medical products and medical equipment, if necessary.
In case of appointment of clinical trials, the period of preliminary technical works shall be suspended for the period of clinical trials, but not more than 1 year from the date of appointment of clinical trials.
6. Registration certificate issuance.
In case of receipt of a positive conclusion of RUE "Center for Expertise and Testing in Healthcare" on compliance of medical products and medical equipment with safety, efficiency and quality requirements, containing the results of expert examinations, inspections, tests and other research:
The applicant shall submit to the Ministry of Health of Belarus the Registration Dossier and the Commission's conclusion on the result of technical works;
The Ministry of Health reviews the submitted documents and adopts a decision regarding the possibility of registration;
The Ministry of Health issues a registration certificate.
In case of appointment of clinical trials, the period of preliminary technical works shall be suspended for the period of clinical trials, but not more than 1 year from the date of appointment of clinical trials.
6. Registration certificate issuance.
In case of receipt of a positive conclusion of RUE "Center for Expertise and Testing in Healthcare" on compliance of medical products and medical equipment with safety, efficiency and quality requirements, containing the results of expert examinations, inspections, tests and other research:
The applicant shall submit to the Ministry of Health of Belarus the Registration Dossier and the Commission's conclusion on the result of technical works;
The Ministry of Health reviews the submitted documents and adopts a decision regarding the possibility of registration;
The Ministry of Health issues a registration certificate.
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Astana, st. Anet baba, 9/3
+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225
+7 (702) 999 1964
+7 (701) 419 2225
Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.
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For request:
electrontest.kz@gmail.com
electrontest.kz@gmail.com
