Registration of medical devices in Uzbekistan.
The main legislative act regulating the procedure for state registration of medical devices is Resolution No. 213 dated March 23, 2018 “Regulations on the procedure for state registration of medical devices medicines, medical products and medical equipment and the issuance of a registration certificate.”
According to this Resolution, medical devices in Uzbekistan are divided into two groups: medical devices (MD) and medical equipment.
Medical devices — products approved for use in medical practice for the prevention, diagnosis and treatment of diseases, as well as for changing the state and functions of the human body;
Medical equipment — apparatuses, equipment, devices, instruments, devices and complexes approved for use in medical practice for prevention, diagnosis and treatment diseases, as well as to identify and change the state and functions of the human body.
The procedure for examining the registration dossier and issuing a registration certificate for medical devices and medical equipment is carried out by the State Center for Expertise and Standardization of Medicines, medical products and medical equipment of the Agency for the Development of the Pharmaceutical Industry of the Ministry of Health.
The registration dossier consists of an administrative part, technical description and test results, color advertising materials and graphic layouts.
As part of the registration dossier, a draft instruction for use is submitted in Uzbek and Russian.
The total period for registration of MD is 155 working days from the date of receipt of the application, and until the decision on registration is made. The deadline for responding to comments is not included in the general registration period.
The registration certificate is issued for a period of 5 years.
The registration process is quite simple and schematically presented in the text of the resolution and applies not only to MD, but also to drugs: