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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
A legislative discussion draft being floated in Congress would require the FDA to develop one set of regulations governing both in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) — to create a more predictable and timely path to market. Read More
Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies, says new guidance from the UK’s MHRA. 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