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Manufacturing
In 2020, the National Bureau conducted unannounced inspections on 89 medical device manufacturers, including 44 IVD companies, 16 sterile product companies, 11 active device companies, 9 implant product companies, 3 denture companies, and 3 independent software company and 3 other companies. The reasons for unannounced inspections are compliance inspections, special inspections, unqualified random inspections, complaints and reports, and occurrence of adverse events. The res