The enterprise performs the following types of work.
1. A set of preliminary technical works that precedes state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus, related to:
- primary expert examination of documents required for state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus;
- inspection of production of medical devices and medical equipment;
- expert examination of the results of sanitary and hygienic tests of medical devices and medical equipment of domestic and foreign manufacture;
- expert examination of the results of technical tests of medical devices and medical equipment of domestic manufacture;
- specialised expert examination of documents required for state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus;
- expert examination and approval of clinical testing programs for medical devices and medical equipment designated by the Ministry of Health, expert examination of test results;
- clinical evaluation based on clinical data and evidence of equivalence of medical equipment previously registered in the Republic of Belarus (for large-sized equipment requiring supply of communications, construction and (or) installation works);
- other studies.
2. A set of technical works related to conducting examinations, inspections of production, testing and other studies for the purpose of registration and formation of a common market for medical devices within the Eurasian Economic Union, as well as conducting other procedures related to the registration of medical devices within the Eurasian Economic Union.
3. A set of preliminary technical works that precedes state registration (confirmation of state registration) of biomedical cell products, introduction of amendments to the registration dossier of biomedical cell products previously registered in the Republic of Belarus.
4. A set of preliminary technical works that precedes state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus, related to:
- primary examination of documents required for state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus;
- testing of medicinal products quality control procedures as well as analysis of medicinal product quality when conducting clinical trials by state health care organisations;
- specialised examination of documents, including test reports on studying bioavailability (bioequivalence) of a generic drug assigned by the Ministry of Health, clinical trials reports of a medicinal product assigned by the Ministry above, and other studies necessary for state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus.
5. Carrying out registration and expert examination of medicinal products for human use in order to register and form a common market for medicinal products within the framework of the Eurasian Economic Union as well as other procedures related to the registration of medicinal products for human use within the framework of the Eurasian Economic Union.
6. Carrying out a set of preliminary technical works to issue a conclusion as part of obtaining permission to conduct clinical trials (tests) of medicinal products.
7. Organization of the examination of documents submitted for making a significant amendment to the program (protocol) of a clinical trial of a medicinal product.
8. Carrying out works on quality control:
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of medicinal products:
- that are in circulation in the territory of the Republic of Belarus (medicinal products and drug products registered in the Republic of Belarus in accordance with the rules of the Union);
- before selling in the territory of the Republic of Belarus on separate parameters for testing laboratories.
9. Technical tests and sterility control of each batch (lot) or part of a batch (lot) of medical devices.
10. Obtaining a conclusion confirming the intended purpose of imported (for the purposes of determining the customs duty rate) medical devices, prosthetic and orthopedic products and medical equipment, or raw materials and materials for their manufacture, components for their production, and semi-finished products for them.
11. Works required for the Ministry of Health to perform the following functions:
- issuance of a certificate (authorisation) to import of registered and unregistered medicinal products and (or) drug substances restricted to movement across the State border of the Republic of Belarus on the grounds established by the laws of the Republic of Belarus;
- issuance of a conclusion (permit document) on the approval of licenses for the import of narcotic drugs, psychotropic substances and their precursors into the Republic of Belarus;
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approval of advertising of:
- medicinal products;
- methods of medical care, works and (or) services constituting medical activity;
- medical equipment;
- medical devices;
- dietary food supplements;
- medicinal products, medical devices and medical equipment carried out within the framework of clinical trials of these medicinal products, medical devices and medical equipment for their subsequent state registration;
- carrying out seminars on issues of circulation of medicinal products, medical devices and medical equipment, ensuring their safety, effectiveness and quality.
