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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
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. 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
The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead test results associated with Magellan’s LeadCare test systems. Read More
Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Read More
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