# China NMPA Inspection - Luoyang Meihua Rensheng Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/luoyang-meihua-rensheng-medical-equipment-co-ltd/d1820db6-b86e-4c9b-a671-e2c779ef090e/
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> China NMPA unannounced inspection for Luoyang Meihua Rensheng Medical Equipment Co., Ltd. published January 09, 2018. On January 9, 2018, the State Food and Drug Administration (SFDA) announced the findings of unannounced inspections conducted on four medical device c

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 11 of 2018 from the State Administration for Market Regulation regarding the suspension of business operations of four medical device companies, including Luoyang Meihua Rensheng Medical Device Co., Ltd.
- Company Name: Luoyang Meihua Rensheng Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: On January 9, 2018, the State Food and Drug Administration (SFDA) announced the findings of unannounced inspections conducted on four medical device companies: Luoyang Meihua Rensheng Medical Device Co., Ltd., Shaanxi Yisheng Medical Device Co., Ltd., Shenyang Huinayuan Trading Co., Ltd., and Chongqing Baihe Medical Device Co., Ltd. These inspections revealed significant deficiencies in their quality management systems and non-compliance with the "Good Supply Practice for Medical Devices."Common issues included inadequate definition of responsibilities for supplier and product verification, adverse event monitoring, and recalls. Companies also failed to properly review and approve their quality management systems, lacked essential record forms, and demonstrated insufficient record retention provisions. Specific concerns highlighted deficient equipment installation and sales records, and a lack of approver signatures on critical forms. Furthermore, facilities were found to be unsuitable for operations, with business premises and warehouses not commensurate with their scale and piled with miscellaneous items. Crucially, some companies, particularly those operating Class III medical devices, lacked compliant computer information management systems essential for product traceability.Consequently, the SFDA mandated that these companies immediately cease all operations for comprehensive rectification. They are required to address all identified non-conformities and can only resume business after passing a follow-up inspection by their respective provincial food and drug administrations, in adherence to the "Regulations on the Supervision and Administration of Medical Devices."

Company: https://www.globalkeysolutions.net/companies/luoyang-meihua-rensheng-medical-equipment-co-ltd/28e27916-a84d-4ecc-863d-963ea7c8deb5/