According to the Decree, from January 1, 2026, the circulation of medical devices and medical equipment is carried out in the following order:
· The state registration of medical devices and medical equipment as medical devices is carried out.;
· Medical devices are classified into four levels of safety, taking into account the high probability of risks associated with human life.;
· The state registration of medical devices is carried out on the basis of positive results of clinical trials.
When applying for a certificate of conformity for medicines and medical devices, the following requirements are required:
· for medicines, starting from January 1, 2027, the national certificate of "Good Manufacturing Practice - GMP" for the type of medicines produced;
· for medical devices - from July 1, 2027, the manufacturer's certificate of conformity to the national standard "ISO:13485".
Also, in accordance with the Decree, from January 1, 2026:
· For the state registration of medicines and the extension of the validity period of the registration certificate, domestic and foreign manufacturers must obtain a national certificate of "Good Manufacturing Practice - GMP";
· according to the results of the state registration of medicines and medical products, a registration certificate with a validity period of five years is issued to domestic and foreign manufacturers.
At the same time, the validity period of registration certificates previously issued to domestic manufacturers on an indefinite basis is set at five years, starting from the date of entry into force of this Decree.;
· The production of medicines and medical devices may be carried out on the basis of an order from their rightholder under a contract by manufacturers who have the appropriate license.;
· The licensing requirement for the retail sale of medical products is lifted, and this activity is carried out by notifying the authorized body.
