Medical Devices Conformity Assessment Body

Identification code UA.TR.116

The Ukrainian Scientific Institute of Certification is a modern, competent body, which comply with all aspects of Ukrainian legislation and is guided by EU law. The body is completely independent and impartial in its decisions which are based solely on objective evidence of conformity.

The body is a recognized industry leader. The professionalism of our specialists has been proved by numerous publications in the press and reports on profile events.

The Ukrainian Scientific Institute of Certification (Uni-CERT) is an accredited conformity assessment body for the following products:

– medical devices
– in vitro diagnostic medical devices
– active implantable medical devices
– large and small domestic appliances; information technology equipment and telecommunication equipment; household electronic equipment; lighting equipment; electrical and electronic tools; toys; recreation and sports equipment;
– personal protective equipment;
– equipment or stationary installation
– electrical equipment designed to be used at rated voltages from 50 to 100 VAC and from 75 to 1500 VDC

In particular, according to the following Technical Regulations:

• Technical Regulation on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013
• Technical Regulation on Medical Devices for In Vitro Diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013
• Technical Regulation on Medical Devices for active implantable medical devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013
• Technical Regulation on personal protective equipment approved by Resolution No. 761 of the Cabinet of Ministers of Ukraine dated August 27, 2008
• Technical Regulations on electromagnetic compatibility of the equipment approved by Resolution No. 1077 of the Cabinet of Ministers of Ukraine dated October 16, 2015

The Ukrainian Scientific Institute of Certification provides the following services as well:

• Certification of management systems for compliance with the requirements of ISO 9001, ISO 13485, ISO 14001, ISO 22000, ISO 45001
• Assessment of the technical documentation (Technical File) within the “self-declaration” procedure;
• Information services;
• Education and training.

We are trusted by more than 350 international medical device manufacturers since:

• Our team consists of 27 full-time experts and 6 freelance auditors;
• Our experience is more than 500 audits in 35 countries;
• We perform assessment of documents and audits in Ukrainian, Russian, English and German languages;
• Our experts report at the industry-specific events and write articles for leading industry information resources;
• Our notified body is a member of the Association of Market Operators of Medical Devices;
• Our notified body is a member of European Business Association (EBA);
• Our notified body is a member of the American Chamber of Commerce (АСС) in Ukraine;
• We have entered into Agreements on recognition of conformity assessment results with leading European notified bodies.

More information about us please can be found on the following page