DEVELOPMENTS IN RULES OF STATE REGISTRATION OF MEDICAL DEVICES
Authors:
1.
Federal Service for Surveillance in Healthcare
Russian Federation
Russian Federation
Type:
Article
Pages:
from 24
to 27
Status:
Published
Received:
25.06.2019
Accepted:
26.06.2019
Published:
26.06.2019
Subject area:
UDK 61 Медицина. Охрана здоровья
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
Language:
Russian
Keywords:
medical devices, registration of medical devices, amending of the registration documents
Abstract (English):
This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.
This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.
Keywords:
medical devices, registration of medical devices, amending of the registration documents
medical devices, registration of medical devices, amending of the registration documents
