Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

The American Chamber of Commerce in Ukraine, jointly with the member company UNI-CERT LLC, is glad to invite you to the upcoming Knowledge Webinar “Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?” scheduled for Tuesday, October 17, 11:00 AM. Don’t miss an exceptional opportunity to learn from speakers on the main principles of […]

Introduction of medical devices into circulation for legal sale

Text is available only in Ukrainian

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

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

The program of the event is available only on Ukrainian or Russian

The most important regulatory changes in the medical device industry. Digest 2021.

The program of the event is available only on Ukrainian or Russian

Conformity assessment of personal protective equipment in accordance with the new Technical Regulations No. 771