Tag: NMPA
Why China’s Evolving Approach to Combination Products Matters Globally
As care increasingly moves into the home, products need to meet not only clinical requirements, but the realities of people’s lives, routines and preferences. This article examines why the FDA puts real-world use at the centre of its updated guidance and why designing for adoption is critical to succeed in medical device development.
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NMPA Human Factors Draft Guidance: Navigating Healthcare Opportunities in China
PDD is a founding executive member of the Human Factors Special Committee and has promoted HFE principles in China since 2015. This article builds on our expertise to interpret the latest draft guidance from the perspective of medical device companies looking to release products in China
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Mitigating Usability Risks: The upcoming NMPA guidelines in China
Mitigating Usability Risks in Medical Device Development, in the light of the upcoming National Medical Product Administration (NMPA) guidelines in China.
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