Standardization of Medical Devices

In today’s reality, the primary task in terms of standardization of medical devices is to create a regulatory and technical framework for import substitution. A number of aspects remain in need of improvement today, namely: manufacturers being forced to use outdated standards; shortage of laboratories accredited to perform technical testing of medical devices; and a shortage of testing equipment. In the open discussion session, government representatives, manufacturers and the medical community will discuss standards-related problems and solutions, as well as the situation with standardization samples, testing equipment and laboratories.

Issues to be discussed:

1.     Urgent issues of national standardization

2.     Issues of metrological support for testing of medical devices

3.     Problems of accreditation of testing laboratories

4.     Shortage of testing equipment