MedTech Europe's Brexit Challenge: Don't Forget The Kid In The EU Divorce
The UK continues to press for favorable trading and regulatory conditions with the EU in its Brexit planning. But EU negotiators seem likely to play it by the book, with no favors shown. The medtech industry watched as the EU withdrawal agreement was approved by the EU27 at the March 2018 Euro Summit. Some weeks prior to that, MedTech Europe chief executive Serge Bernasconi told In Vivo of his fears for EU medtech if the industry was too slow in preparing for UK withdrawal.
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With the UK scheduled to leave the EU one year, the UK medtech and lifesciences industries were becoming increasingly concerned about the government's lack ofplanning and the risk of being left high and dry in the post-Brexit environment. But the UK has bought more time now that the EU agreed to a withdrawal transition phase until the end of 2020. There are potentially meaningful positives in the agreement for medtechs on either side of the English Channel.
The Swedish liquid biopsy start-up expects to be the first company to secure US FDA approval for a metabolism-based urine test for the early detection of kidney cancer in post-surgery patients.
Singapore Prepares UDI System, Malaysia Seeks Regulatory Improvements And Indonesia Adjusts To Changing Environment
Medtech industry representatives from ASEANMed member economies, notably Singapore, Malaysia and Indonesia, provided regulatory updates at the February Asia Regulatory Roundtable. These roundtables are organized by the ARQon consultancy and the Asia Regulatory Professional Association (ARPA). They are sponsored by Medtech Insight.