Understanding Regulatory Requirements and Registration Practices for Medical Devices in Germany: Perspectives of Industrial Experts

Leonie Levin
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引用次数: 0

Abstract

The medical device industry in Germany is advanced and innovative. Moreover, it stands at the third position in the world in terms of volume and quality of medical device production in a year, as well as annual revenue generation from the industry. However, there is a lack of understanding regarding the regulatory requirements and registration practices that can be used by new entrants in the market for medical devices in Germany. Therefore, the current study aimed to analyze these processes from the perspective of industrial experts. The researcher conducted semi-structured interviews with five biotechnologists and five legislative managers working within the biotech industry in Germany. The findings include a discussion regarding regulatory requirements, the importance of regulatory practices, innovation in the medical device industry, and the registration practices for medical devices in Germany. In the future, there is a need to conduct any empirical and statistical analysis regarding the impact of regulatory requirements and practices, innovation, funding, and research and development on the success of the medical device industry in Germany.
了解德国医疗器械的监管要求和注册实践:行业专家的观点
德国的医疗器械行业具有先进性和创新性。此外,就每年生产的医疗器械的数量和质量以及该行业的年度收入而言,它在世界上排名第三。然而,对于德国医疗器械市场新进入者可以使用的监管要求和注册做法缺乏了解。因此,本研究旨在从产业专家的角度来分析这些过程。研究人员对在德国生物技术行业工作的五名生物技术专家和五名立法管理人员进行了半结构化采访。调查结果包括关于监管要求的讨论,监管实践的重要性,医疗器械行业的创新,以及德国医疗器械的注册实践。在未来,有必要对监管要求和实践、创新、资金和研发对德国医疗器械行业成功的影响进行任何实证和统计分析。
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