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South Korean medical device industry and excessive regulations

healthcare healthcare intellectual capital korea medical device regulatory landscape

The article suggests that medical device industry, particularly in telemedicine, is mired in excessive regulations.  Several aspects of regulatory environment in Korea present challenges for local companies.  First, companies are compelled to use cloud services instead of better ones provided by Amazon, Google, etc. Second, the government takes too long in approving innovative devices.  Third, lack of clear guideline in classification of certain devices such as smartphone apps for blood sugar management.

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