Registration of medical equipment Uzbekistan
During state registration (re-registration) and making changes to the registration dossier in the Republic of Uzbekistan, medical equipment undergoes procedures for confirming its quality, safety, and effectiveness.
01
Laws and regulations governing the process of registration of medical equipment:
Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 213 “On Approval of the Regulations on the Procedure for State Registration of Medicines, Medical Devices, and Medical Equipment and the Issuance of a Registration Certificate” dated 23 March 2019.
The following products are subject to registration:
- Devices and equipment based on the use of ionising radiation and other types of
- Radiation
- Diagnostic equipment and monitoring systems
- Surgical devices, anaesthesiology and resuscitation equipment
- Devices and accessories for dialysis, haemodialysis, plasmapheresis, and angiography
- Equipment and supplies for clinics and clinical diagnostic laboratories
- Kits of diagnostic tools, reagents and other laboratory diagnostic tools
- Hospital equipment
- ENT equipment
- Ophthalmology equipment
- Obstetrics and gynaecology equipment
- Dental equipment
- Physiotherapy equipment
02
Registration stages:
01
Preparation of the registration dossier, collection of all necessary documents
02
Preliminary analysis of the registration dossier, evaluation of the collected package of documents and making adjustments
03
Submission of an application for the procedure, submission of an application to the state body for preparation of an agreement and carrying out the primary expert examination of the documents
04
Primary expert examination of the documents: administrative, chemical, biological, technical parts of the registration documents are examined by experts
05
Secondary expert examination: a repeated expert examination of the registration documents of the medical equipment, with the involvement of independent experts, is carried out
06
Testing in accredited laboratories or at the medical equipment installation site
07
Clinical trials or clinical evaluation, evaluation or trials of the medical equipment in clinics or in the state body
08
Instructions for the use (operation) and labelling of the medical equipment (domestic production) or amendments or supplements made to them are agreed on
09
Regulatory documents of the medical equipment (test results) are prepared for approval, with the issuance of an order of the Ministry of Health of the Republic of Uzbekistan with regard to making a decision on registration
10
Issuance of the registration certificate, with the placement of information on registration (re-registration) in the State Register of the Ministry of Health of the Republic of Uzbekistan
Write us
