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South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. Read More
Congress reached a deal on a comprehensive, 1,600-page bill to fund the federal government through September 30 – and give the FDA an extra $39 million. Read More
The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures. Read More