Members of the AmCham Working Group on Healthcare Hardware & Medical Devices Manufacturers, functioning under the AmCham Healthcare Committee, met online with the team of the Office of Simple Solutions and Results.
The activities of the AmCham Committee are aimed at establishing a competitive landscape for the healthcare sector's development through the creation of a transparent and efficient regulatory system.
One of the priorities of the Committee’s Working Group on Healthcare Hardware & Medical Devices Manufacturers is to harmonize regulatory acts in healthcare sphere with the EU legislation.
During the meeting, the participants had an opportunity to discuss the recognition of results of conformity assessment for medical devices conducted outside Ukraine.
AmCham member companies' experts support the certification of healthcare medical devices using the procedure of recognition of results of conformity assessment for medical devices conducted in the EU in accordance with the Article 45 of the Law of Ukraine "On technical regulations and conformity assessment". They consider it a legally regulated, generally accepted practice, which is an essential requirement for the European vector of Ukraine's development and the presence on the national market of the most technological products of the world's leading manufacturers.
The American Chamber of Commerce in Ukraine will continue to work on reforming the healthcare system, which will attract new investments into the sphere and create a level playing field for market participants.