" Medical Device Manufacturing Quality Management Regulations (2014 Edition)" (hereinafter referred to as "Specifications") marks the coming of the most stringent regulatory era in the medical device manufacturing industry. The State Food and Drug Administration requires that all third-class medical device manufacturers must comply with the requirements of the Code from January 1, 2016. Other medical device manufacturers should meet the requirements of the Code on January 1, 2018. Before and after the spring of this year, the National Bureau issued a notice requesting the local food and drug supervision departments to carry out supervision on the third type of medical device manufacturers. The three provinces of Guangdong, Anhui and Zhejiang have already opened the river. Many machinery enterprises have been rectified within a time limit, suspended for rectification, and even cancelled. Relevant information, China's Medical Equipment has been reported recently. The question is, how is the most stringent regulation in history implemented? It is reported that the Opinions of the Food and Drug Administration of Anhui Province on the Supervision and Implementation of the Quality Management Regulations for Medical Device Production stipulates that in the daily supervision and inspection, as long as the general project of the enterprise does not meet the requirements, the company shall be ordered to rectify within a time limit; If the project does not meet the requirements, or if only the general project does not meet the requirements but has a direct impact on the quality of the product, the enterprise must stop production and rectification; if the circumstances are serious, the production license will be directly revoked. It is not difficult to see that the key projects are not required to stop production and rectification, which can be described as a boxing life and death. The catastrophic impact of the suspension of production on the company is self-evident. Then, what are the “key projects†that will lead to the suspension of production? In October last year, the National Bureau issued four on-site inspection guidelines on its official website, including a general principle and three specific types of principles (sterile, implantable medical devices and in vitro diagnostic reagents). China's medical devices will summarize the key items as follows, a total of 57: 1. Organizations and personnel, counting 5 items Remarks: All key projects that are not specified are common to all types of enterprises, the same below. 2, plant and facilities, count 8 items Disposable Infusion Pump,Infusion Pump,pump infusion,syringe infusion pump,disposable infusion pump pca Anesthesia Medical Co., Ltd. , https://www.honestymed.com
