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The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction. Read More
The FDA issued “immediately in effect” guidance for manufacturers of Class I and unclassified medical devices on compliance dates for meeting unique device identification requirements. Read More
Health Canada pointed to the last paragraph in the Food and Drugs Act’s definition of a medical device as a significant 2014 addition intended to help distinguish between products. Read More
Marcelo do Ó, managing director and partner at L.E.K. Consulting, in São Paulo, Brazil, talked with FDAnews about recent changes by Brazil’s National Surveillance Agency. Read More
Brazil has made a number of regulatory changes aimed at simplifying market entry for foreign devicemakers, such as getting rid of certain import requirements. Read More
A successful paradigm shift focusing on software is heavily dependent on collaborative interactions, said Bakul Patel, CDRH’s associate director for digital health. Read More