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Many countries regulate medical devices and in vitro diagnostic devices. We are experienced medical device regulatory consultant in medical device registration such as Taiwan FDA, US FDA 510k, EU CE marking, Health Canada, Russia MOH, Brazil ANVISA, Japan PMDA…

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medial devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council 90/385/EEC and 93/42/EEC

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medial devices and repealing Directive 98/79/EC and commision decision 2010/227/EU

CE EU medical device regulation (MDR)

CE EU In vitro diagnositc regluation (IVDR)