EU certificate for medical devices: the thorny path of recognition

Other news

01.02.2023

Register of persons responsible for the placing medical devices on the market has become operational in Ukraine

The Register of persons responsible for the placing medical devices on the market is displayed in public access on the official website of the State Service of Ukraine on Medicines and Drugs Control, providing the possibility of convenient search of information in the Register of Persons in accordance with the specified search parameters, at the […]

01.06.2021

Documenting the quality management system for the production of medical products according to ISO 13485:2018

Quality management // № 5 (41), May 2021 The text of the article is available only in Ukrainian

13.03.2023

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

PROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates