Registration of medical devices Uzbekistan
The certificate is a document confirming the fact of state registration and permission of the Ministry of Health of the Republic of Uzbekistan with regard to the right to use a medicinal product, a medical device and medical equipment in medical practice.
01
What types of medical devices need to be registered?
According to 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 2018,
the following products are subject to registration:
- Medicinal products
- New combinations of medicinal products registered in the Republic of Uzbekistan
- Medicinal products previously registered in the Republic of Uzbekistan, but produced in other dosage forms, dosages or by another manufacturer
- Medical products
- Medical 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
Import of samples of medical devices / obtaining feedback from clinics, contacting the state body with a written request
04
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
05
Primary expert examination of the documents, analysis of the documents of the registration dossier with the issuance of the agreement and an invoice for the expert examination upon completion of the stage
06
Agreement negotiation and making payment, signing the agreement, making payment according to the invoice
07
Specialised expert examination, including laboratory testing
08
Passing the Expert Council, submission of the application to the Expert Council in the state body
09
Issuance of the registration certificate
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