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The FDA cited devicemakers in Sweden, Germany and China for GMP and other lapses, including inadequate design history files and complaint handling. Read More
The International Medical Device Regulators Forum (IMDRF) has released a draft guidance laying out regulatory pathways for personalized medical devices. Read More
Russia signed an agreement with Brazil, Argentina and Mexico to share best practices and information on quality, efficacy and safety of medical products as well as adverse event information, on the first day of the International Medical Device Regulators Forum held in Moscow, March 19-21. Read More
The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to a report by the European Commission. Read More
The FDA cited three device companies for medical device reporting, corrective and preventive actions and other violations found during inspections. Read More
The recent International Medical Device Regulators Forum (IMDRF) meeting in Beijing featured presentations by international regulatory authorities on their significant regulatory changes. Read More
The International Medical Device Regulators Forum (IMDRF) has released final guidances on optimizing standards for regulatory use, essential principles of safety and performance, and definitions for personalized devices. Read More
The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and revise companion documents so devicemakers and auditing organizations are clear on expectations. Read More
Following up on a proposal from Australia’s Therapeutic Goods Administration, the International Medical Device Regulators Forum released a new consultation on personalized medical devices following its March meeting in Shanghai. Read More