Regulatory System is Formed
Regulatory system – a basis of the general market of medical devices at Eurasia Economical Union (EEU) has been completed. It is legal framework is based on the Agreement on Union, Treaty on unified principles and rules of circulation and a package of documents approved for its implementation and covering development, study, manufacture and release of all types of medical devices within the framework of Eurasia Economic Union. Unified regulation of the market of medical devices, circulating in the Union member-countries suggests benchmarking of practices, which will certainly improve the quality of medical devices. At the same time, unified regulation of the market will relax barriers related to specifics of national markets of medical devices.
One of the principles of functioning of the unified EEU market suggests uniform requirements to labeling of medical devices. Clinical study of devices of high classes of potential risk, active implanted medical devices will be compulsory. In the process of marketing authorization renewal of medical devices for access to general market, one of the key parameters of suitability of results of clinical studies completed before 2016 will be their compliance to standards of evidence-based research. The regional principle, related to the notion of partial localization (minimum one study of medical devices has to be conducted in the Union or in states, implementing recommendations of the International forum of regulatory authorities of medical devices) should be scrupulously followed.
Mutual recognition of study (research) and expertise results by authorized organs of EEU member-countries obtained in the process of registration of medical devices, and the possibility of single-time product release to markets of all Union member-states. It will help avoid duplication of safety and efficacy assessment of drugs and reduce the time of approval, thus decreasing expenses of all Union member-states and make medical device more affordable in EEU countries.
The unified market of medical devices will start operating in full format from the end of this year. But according to the agreement achieved manufacturers will be provided a transitional period of six years when both procedures of approval of medical devices will work – both according to unified requirements of the Union and according to the legislation of the EEU countries. In conclusion, both marketing authorization systems, both national and unified medical device marketing approval system of EEU will be operating until December 31, 2021. It will provide an opportunity for pharmaceutical manufacturers to harmonize manufacture with new requirements and have a critical view of their portfolio of medical devices.