A comparative study of medical device regulation between countries based on their economies

ABSTRACT

Introduction

Medical devices play a crucial role in healthcare, addressing the diagnosis, treatment, and monitoring of various medical conditions. This study conducts a comprehensive analysis of medical device regulations across nations, considering the economic contexts of diverse countries.

Areas Covered

The research involves a comparative examination of medical device regulations, dissecting unique frameworks in countries like the United States (US), European Union (EU), India, and Africa. These nations were chosen based on economic significance, market influence, and regulatory structures. The study aims to achieve a nuanced understanding of global medical device regulation, develop strategies to enhance guidelines, especially in developing nations, and provide recommendations for improvements in relevant regions.

Expert Opinion

Through this study, valuable insights are gained into the diverse regulatory frameworks governing medical devices globally. The analysis identifies areas within these frameworks that require improvement, as well as strategies to enhance regulatory guidelines, particularly addressing the specific needs of developing economies. Ultimately, the research provides significant recommendations for policymakers and industry stakeholders. By offering a deeper understanding of regulatory intricacies, this study establishes pragmatic approaches to address challenges within the medical device industry and improve the regulatory landscape on a global scale.

KEYWORDS:

• Diagnostic devices
• global harmonisation task force (GHTF)
• international medical device regulators forum (IMDRF)
• medical devices
• regulations of medical devices

Article highlights

• The paper outlines recommendations for enhancing medical device laws in developing countries, focusing on key areas such as awareness, education, regulatory body strengthening, innovation promotion, and pharmaceutical regulations update.

• Emphasis is placed on the significance of benchmarking regulatory frameworks to evaluate the effectiveness of institutional development plans.

• The document underscores the involvement of patients in the design and testing phases of medical devices as a crucial element to ensure their effectiveness and user-friendliness.

• Specific cases, such as the Mitra-Clip® Delivery System, are discussed to emphasize the importance of comprehensive adverse event reporting and the implications of device recalls in the context of medical device malfunctions.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.