Meeting of the Chamber Working Group on Healthcare Hardware & Medical Devices Manufacturers


The meeting has been devoted to the following:

1. At the beginning of September, Technical Regulation on legally controlled measuring instruments, approved by Decree of the Cabinet of Ministers of Ukraine #94 dated January 13, 2016, came into force. Among the list of products covered by this Regulation are the following medical products:

- Analyzers of medical designation: biochemical, hematological, gas and electrolytes in the blood, immunoferment, fluorescent, chemiluminescent, electrochemical;

- Measuring blood pressure devices (i.e. medical devices – sphygmomanometers, tonometers);

- Measuring devices of alcohol in blood and breath;

- Cardio defibrillators;

- Medical thermometers;

- Monitors of patient;

- Ultrasound diagnostic devices.

Reconciliation of positions among the Working Group on the possible ways to avoid the double regulation.

2. Amendments to Technical Regulations ##753, 754, 755 in the part of:

- Mandatory maintenance by the State Health Service of national public registry of medical devices that have passed the conformity assessment procedure;

- Mandatory maintenance by the State Health Service of national public register of authorized representatives on medical devices that are manufactured by non-residents;

- Expansion of the list of possible international symbols to apply for labeling of medical devices.

3. Implementation of information security mode by conformity assessment bodies in carrying out the conformity assessment procedures.

4. Meeting with Pavlo Harchyk, President of the Association of Market Operators of Medical Devices:

- Developments in the preparation of the Draft Law "On Medical Devices";

- Development of a common position among associations.