To strengthen the supervision and regulation of the Medical Device Industry, NMPA Hubei Branch conducted 43 Unannounced Inspection in 2023. Thirty-seven (37) Domestic Manufacturing Facilities and six (6) OEM Manufacturer Facilities outside of Hubei were involved. Two of them were for-cause inspections related to Adverse Events.
There were 268 Inspection Citations recorded, 32 of them were major deficiencies, 236 of them were minors. Due to the inspection, three (3) Manufacture Licenses were revoked; two (2) facilities were shut down for rectification; the others were pending to follow up inspection.