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The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices. Read More
Most of the provisions in the 21st Century Cures Act clarifying medical software regulation are straightforward and welcomed by industry, but it is unclear how the FDA will apply a provision on clinical decision support software. Read More
Every medical device imported into Malaysia for sale must have a single authorized representative, according to a new circular from the country’s Medical Device Authority. Read More
The FDA has had to postpone meetings with Capitol Hill staff to discuss upcoming user fee legislation, after the Trump administration directed agencies to halt correspondence with members of Congress. Read More