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A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Read More
China’s Food and Drug Administration plans to revise more than 300 standards by 2020, according to a new two-year plan for bringing the country’s medical devices and in vitro diagnostics up to international standards. Read More
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but is making adjustments to help small to medium-sized enterprises comply. Read More
India’s CDSCO issued answers to frequently asked questions on its new medical device rules and said licenses granted after Jan. 1, 2018 will remain valid indefinitely. Read More
The agency is adding requirements for statements of compliance with FDA regulations covering human subject protection and institutional review boards. Read More