Regulatory Tightening and "Secure by Design"
2026 has seen a global surge in strict cybersecurity regulations. In the US, the FDA now requires manufacturers to prove a device is "Secure by Design" before it can be sold. Similarly, in India, the CDSCO has integrated cybersecurity as a mandatory part of medical device licensing.
These regulations mean that security is no longer an afterthought. Manufacturers must provide evidence of penetration testing, secure coding practices, and a plan for long-term security updates. In 2026, if a manufacturer cannot guarantee security support for the expected life of the device, it simply cannot enter the market.
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