Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA’s draft guidances for OTC and prescription point-of-care blood glucose tests create overly burdensome clinical trial requirements that may chill development of new products, stakeholders say. Read More
Devicemakers importing goods for sale in Europe will need to comply with a revised hazardous substances directive if they are deemed “free for circulation on the EU market,” an industry guidance says. Read More
Citing continuing confusion among devicemakers regarding borderline products, the UK’s Medicines and Healthcare products Regulatory Agency last month issued guidance clarifying when they qualify as a medical device in the EU. Read More
China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More