A comparative view on medical device regulations

In light of the recent regulatory development in MedTech industry in both EU and China, in this article, we analyzed the differences and similarities of the regulatory framework in the two continents through the following lenses:

  • Regulatory scope
  • Supervision
  • Responsibilities
  • Transparency & traceability issues
  • Clinical requirements
  • International alignment

Are you curious to know what are the general trends and patterns in both EU and China’s MedTech regulatory scheme? Are you interested in the impact of regulatory development on your market entry strategy in different regions?  Take a look at our article here in:

EN version

CN version


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Post date: April 03, 2017
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