# China NMPA Inspection - Zhejiang Haisheng Medical Equipment Co., Ltd. - April 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/zhejiang-haisheng-medical-equipment-co-ltd/d436eac7-d12e-4b4f-b975-9c97a0da704b/
Source feed: China

> China NMPA unannounced inspection for Zhejiang Haisheng Medical Equipment Co., Ltd. published April 26, 2016. The National Medical Products Administration (NMPA) published an "Unannounced Inspection Report on Zhejiang Haisheng Medical Device Co., Ltd." on Apri

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Zhejiang Haisheng Medical Equipment Co., Ltd.
- Company Name: Zhejiang Haisheng Medical Equipment Co., Ltd.
- Publication Date: 2016-04-26
- Product Type: Device
- Summary: The National Medical Products Administration (NMPA) published an "Unannounced Inspection Report on Zhejiang Haisheng Medical Device Co., Ltd." on April 26, 2016. This report details the findings of an unannounced on-site inspection conducted at Zhejiang Haisheng Medical Device Co., Ltd. The primary finding from this inspection was the company's ongoing application to cancel the registration certificate for its disposable tracheotomy tubes. This indicates a voluntary withdrawal or cessation of production/marketing for this specific medical device by the company. In response to this, the regulatory body, identified as the State Food and Drug Administration (an earlier designation for China's national drug and medical device regulator, now NMPA), issued a directive. The directive specifically instructed the Zhejiang Provincial Food and Drug Administration to swiftly verify and confirm the precise status of the company's application for registration cancellation. This action underscores the regulatory framework's emphasis on maintaining accurate and up-to-date records regarding medical device market authorizations and withdrawals, ensuring regulatory clarity and patient safety. The inspection, while not identifying typical compliance violations, focused on confirming the appropriate regulatory standing of a key medical product, highlighting the dynamic nature of product lifecycle management within the stringent Chinese regulatory environment for medical devices.

Company: https://www.globalkeysolutions.net/companies/zhejiang-haisheng-medical-equipment-co-ltd/f4b969e9-b631-4e2a-b4f8-ee5c72690d2b/