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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