Abstract

REGULATORY CHALLENGES IN APPROVAL OF MEDICAL DEVICES IN ICH AND SELECTED COUNTRIES, FOR BETTER REGULATORY DELIVERY

Y. Ratna Sindhu* and Bandela Srinadh

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Abstract

Ensuring the availability of quality drugs and health products starts with effective management at the national level. The word "medical devices" will cover wide range of products, from simple depressors of tongue to cardiac stents. As the safety & effectiveness of medical devices is critical to human health, the products must be regulated by stringent regulations categorized on different levels of risk. The objective of this study is to identify the regulatory challenges in ICH and selected countries which include India, South Africa, Brazil, Singapore and Saudi Arabia and address them for better regulatory delivery with special emphasis on regulatory changes in these countries & the current status of global medical device harmonization. To identify the challenges faced by Medical device regulatory affair professional while filling the application for approval around the world and to address the challenges of Medical device products in emerging markets (Brazil, Singapore, Saudi Arabia and South Africa) and medical device industry stakeholders and gathered their responses and drawn. The study realized that medical device regulations around the world is very diverse and regulatory Affairs professional’s primary challenge is the absence of regulatory harmonization across distinct Geographical locations. Different stakeholders from industries express that all information is not available on the website of emerging countries for filling of the complete application. Medical devices depend on computer software to carry out their tasks, the question of whether the software itself can be recommended as “medical device”? Unfortunately, software as medical device cannot be put on the market without first passing regulatory audits to confirm that the product is safe and efficient and Association of Southeast Asian Nations [ASEAN] Is going to play a major role in harmonizing regulatory guidelines for medical devices and sensitize international best practices and provides WHO technical support to national regulatory authorities.

Keywords: Harmonization, Transparency, International Medical device Regulatory Forum.