‘A Divorce But We Weren’t Even Married’ – Swiss Medtech Expects No EU MRA Before May
EU grace period might be allowed for Swiss devices in April
A last-minute solution to the unresolved EU MRA issue is unlikely, so local manufacturers must prepare for Switzerland to be a “third country” to the EU after the MDR comes fully into force.
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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.