With an aging population in developed countries, coupled with declining birth rates, higher life expectancy, and an increasing prevalence of lifestyle diseases and economic development in emerging markets, there is a rising demand for medical devices. According to a market forecast, the medical device industry is set to grow at a CAGR of 5% over the next decade1. However, the industry is facing multiple challenges, including:
- Recurring patient safety concerns
- As Increase in pricing pressure
- Cybersecurity threats
An increased global outcry for more stringent regulations to ensure only high-quality devices enter the market, is resulting in worldwide regulatory bodies worldwide making changes to their systems and processes.
This report looks at some of the recent changes in the medical device regulatory environment in major markets, such as the US, EU, Canada, China, and Australia. It also addresses what medical device manufacturers can do to navigate these regulatory changes.
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