Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products : Current Directions in Biomedical Engineering

摘要

Due to globalization and the quick development of technology, each government aims to ensure the safety and performance of products brought to their markets to protect its population. The peoples’ health state is of great significance and influenced easily by the quality of medical products. Therefore governments enact laws, directives and regulations to assure that quality. Nevertheless, these regulations can impede innovation and create trade barriers which result in an adverse effect on national economies. Where in some states no regulatory system is installed, others have highly sophisticated registration requirements that must be met. These diversities result in a challenge especially for small and medium sized companies, whose resources are often limited. [1] Manufacturers must control these diverse regulatory requirements by analyzing each market. Therefore an efficient procedure of registration should be defined that streamlines different registration requirements and ensures regulatory compliance. Next to regulatory authorities describing these requirements also harmonization groups play an important role in the design of the global regulatory landscape. Therefore also the most important harmonization groups and their current activities were investigated. The analysis showed that the impact of harmonization groups can be identified easily since new defined or updated regulatory requirements are oriented on their guideline. Still the harmonization of regulatory requirements in the medical device sector is not sufficiently enhanced. Thus the confrontation with each national regulatory system is inevitable.