registration of medical devices in the Republic of Belarus

Registration certificate for MT and IMN - a document that confirms that the products have passed hygienic, technical and clinical trials. A registration certificate is required to authorize the use in medical practice of medical equipment and medical devices in the Republic of Belarus.
Products subject to registration as MT and IMN:
Medical equipment (MT) - medical devices, devices and equipment used separately, in complexes or systems for medical purposes for the prevention, diagnosis, treatment, rehabilitation, prosthetics of the population, research in the field of health.
Medical devices (medical devices) - products and auxiliary materials used for the prevention, diagnosis, treatment, rehabilitation, prosthetics of the population, research in the field of health.
In accordance with the current legislation of the Republic of Belarus, medical equipment and medical products of foreign and domestic production can be used on the territory of the Republic of Belarus only after its registration with the Ministry of Health of the Republic of Belarus and entering into the Register of medical equipment and medical products permitted for medical use in the Republic of Belarus .
Important features of the registration of medical devices in the Republic of Belarus:
Registration of medical products is carried out on the basis of the results of relevant tests and assessments confirming the quality, effectiveness and safety of products.
When registering MT and IMN of a foreign manufacturer who first submits an application, it is necessary to conduct an inspection check of the manufacturing plant by experts of the Ministry of Health of the Republic of Belarus.
The cost of registration and terms of paperwork:
The cost and timing of registration of medical devices depend on many factors, such as: type and quantity of products, availability of all necessary for paperwork, provision of product samples and analysis of the state of production (if necessary), etc.

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