# China NMPA Inspection - Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd. - September 18, 2020

Source: https://www.globalkeysolutions.net/records/china_inspection/wuhan-banbiantian-minimally-invasive-medical-technology-co-ltd/c2b1edd8-fc7f-48e3-9914-2cfda60cde05/
Source feed: China

> China NMPA unannounced inspection for Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd. published September 18, 2020. The National Medical Products Administration (NMPA) conducted an unannounced inspection of Wuhan Banbiantian Minimally Invasive Medical Technology Co.

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 63 of 2020 from the National Medical Products Administration regarding the results of a surprise inspection of Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd.
- Company Name: Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd.
- Publication Date: 2020-09-18
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) conducted an unannounced inspection of Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd., with findings announced on September 18, 2020. The inspection revealed serious deficiencies in the company's quality management system, primarily concerning design and development and non-conforming product control, violating the *Good Manufacturing Practice for Medical Devices*.

Key issues in design and development included discrepancies between actual product structures and design drawings, such as an isolation transformer present but absent from wiring diagrams, and a foot switch without a corresponding socket in back panel diagrams. Additionally, products manufactured after registration had internal designs inconsistent with the initial inspection samples. These unapproved design changes, including altered component layouts, missing metal casings, added power modules, and differing fuse specifications, were implemented without proper risk assessment, potentially affecting product safety and effectiveness.

Regarding non-conforming products, the company's actual corrective measures did not align with its review records, failing to meet requirements for proper identification, recording, isolation, and disposal.

Consequently, the NMPA has instructed the Hubei Provincial Medical Products Administration to order the company to immediately cease production for rectification, impose severe penalties for violations of the *Regulations on the Supervision and Administration of Medical Devices*, and assess product safety risks to recall relevant hazardous products. Production may resume only after all rectification items are completed and a re-inspection is successfully passed, with progress reported to the NMPA.

Company: https://www.globalkeysolutions.net/companies/wuhan-banbiantian-minimally-invasive-medical-technology-co-ltd/5f59e24e-c575-4641-ab31-be2f379a8b97/