[Depth] Brexit affects China's medical device industry in three aspects
Regulatory
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The United Kingdom is now a member of the European Union. The medical regulations are consistent with the EU. As long as it meets the CE standards, there will be no problems in the UK.
However, CE is the abbreviation of French CONFORMITE EUROPEENNE, meaning "European Community", the predecessor of the European Community, the European Union.
If the UK is out of Europe, CE is no longer applicable to the UK. It is very likely that the UK is the most comprehensive in the EU's regulatory system, especially in terms of recalls and notifications of adverse events.
According to the British personality, it is very likely that after the Brexit, a standard belonging to the British Isles will be produced. The drafting of this standard may be based on CE standards, making detailed changes to better match the situation in the UK itself.
If there is such a standard, it is undoubtedly a bad news for Chinese companies. How many markets will this investment bring? It is not known whether the UK Ministry of Health will build this system into another FDA certification.
However, a new system cost is also a matter for the British government to consider. Considering the financial pressure of the British government after the Brexit, changing the CE system should not be a problem to be considered in the next 2-3 years.
Exchange rate change
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