# China NMPA Inspection - Shanghai MicroPort Medical Devices (Group) Co., Ltd. - November 02, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-microport-medical-devices-group-co-ltd/55e29af3-2d2b-4218-bce0-4b01d110c56a/
Source feed: China

> China NMPA unannounced inspection for Shanghai MicroPort Medical Devices (Group) Co., Ltd. published November 02, 2016. An unannounced inspection conducted by the Shanghai Municipal Food and Drug Administration revealed significant compliance issues at Shanghai MicroPor

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## Details

- Record Type: CHINA_INSPECTION
- Title: Surprise inspection of Shanghai MicroPort Medical Devices (Group) Co., Ltd.
- Company Name: Shanghai MicroPort Medical Devices (Group) Co., Ltd.
- Publication Date: 2016-11-02
- Product Type: devices
- Summary: An unannounced inspection conducted by the Shanghai Municipal Food and Drug Administration revealed significant compliance issues at Shanghai MicroPort Medical Devices (Group) Co., Ltd. The inspection, detailed in a report published on November 2, 2016, identified that the company's operational practices and quality management system were deficient. Specifically, the inspection found that Shanghai MicroPort Medical Devices (Group) Co., Ltd. did not adhere to the 'Good Manufacturing Practice for Medical Devices' (GMP). This non-compliance indicates potential shortcomings in critical areas such as design control, production processes, quality control, and overall management of product quality and safety. Deficiencies in the quality management system suggest systemic weaknesses that could impact the reliability, safety, and effectiveness of their medical devices. As a result of these findings, the Shanghai Municipal Food and Drug Administration has mandated that Shanghai MicroPort Medical Devices (Group) Co., Ltd. promptly address and rectify all identified deficiencies. The company is required to implement comprehensive corrective actions within a stipulated timeframe to ensure full compliance with the regulatory framework governing medical device manufacturing. This directive underscores the regulatory body's commitment to upholding product quality and patient safety standards within the medical device industry in China.

Company: https://www.globalkeysolutions.net/companies/shanghai-microport-medical-devices-group-co-ltd/a13b4158-d7f9-4c9a-85b9-d612230c5cc0/