Thursday, May 25, 2023

11:30 AM - 12:15 PM

Hall M

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Details

The regulation of medical devices contributes to the reduction of potential risks arising from their use and allows the population access to safe, effective and high-quality medical devices, contributing to better public health outcomes. The Medtech industry is a regulated industry, with good reason. The cost of compliance to that regulation is a cost of doing business in this sector and all regulations or changes to existing regulations have a cost that is imposed on a Medtech business. This is often referred to as the regulatory burden. Costs can be sliced and diced in a few ways but roughly fall under two categories compliance costs and delay costs. Compliance costs are those costs incurred by the Medtech company primarily to demonstrate compliance with the regulation (usually record keeping and reporting costs) and costs incurred to deliver the regulated outcomes being sought (usually purchase and maintenance costs). Delay costs can be viewed as expenses and loss of income incurred by a Medtech company through an application delay or an approval delay. This regulatory burden can be exacerbated when the target sales territories are regulated by differing bodies that apply differing rules or standards. The discussion of regulatory harmonisation and regulatory convergence is a long wished for outcome to maximise alignment of medical device sector-specific technical regulations, standards and conformity assessment criteria to internationally harmonized global standards. Currently there are more than two million different types of medical devices circulate on the world market, categorized into more than 22,000 groups of generic devices. In this session our panel will focus on the importance of and progress towards the implementation of a globally aligned approach that contributes to the access of safe products and do not impede innovation or create unnecessary barriers to trade.

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Speaker