Heavyweight: GSP of medical devices landed and 180000 enterprises shuffled

Source: on January 19, 2015, the State Food and Drug Administration (CFDA) released the GSP (hereinafter referred to as the "specification") through the official website, which was finally put into operation after many times of drafting, modification and consultation More than ten thousand medical equipment management enterprises have ushered in the era of strict management, and the wave is also bound to be an era of industry reshuffle CFDA issued the news that in order to strengthen the quality management of medical device operation, standardize the management behavior of medical device operation, and ensure the safety and effectiveness of public use of equipment, CFDA formulated the management specification of medical device operation quality in accordance with the newly issued regulations on the supervision and management of medical device and the management measures for the supervision and management of medical device operation It was deliberated and approved by the 16th director general's office meeting of CFDA in 2014, published on December 12, and implemented as of the date of promulgation There are nine chapters and sixty-six articles in the code, which requires medical device business enterprises to establish and improve the quality management system in accordance with the code, and take effective quality control measures in the purchase, acceptance, storage, sales, transportation, after-sales service and other links of medical devices to ensure the quality and safety in the business process In order to fully implement the code and in combination with the release of the code, CFDA will also accelerate the capacity building of medical device supervision and inspection team, improve the ability and level of supervision personnel, lay a good foundation for the implementation of the code, and further improve the quality assurance level of medical device operation enterprises There seems to be a big difference between the fact that there is no independent medical device warehouse in the five cases and the GSP certification of drugs, which proves that the General Administration has taken care of the special situation of the device industry, and the certification is not one size fits all This will bring benefits to many operating enterprises, not only reducing the cost of certification construction and transformation, but also the cost of warehouse operation and management （1） The business place display conditions of a single store retail enterprise can meet the performance requirements of the medical device products it operates, and the business place can meet the needs of its business scale and variety display; (2) the chain retail business of medical device; （3） All the medical equipment enterprises entrusted to provide storage and distribution services for other medical equipment production and operation enterprises for storage; (4) specialized in medical equipment software or large-scale medical equipment such as medical magnetic resonance, medical X-ray, medical high-energy ray and medical nuclide equipment; （5） Other circumstances stipulated by the provincial food and drug administration that no separate warehouse for medical devices may be set up How long will certification last? The pharmaceutical industry started GSP certification from 2002 to 2003 This year, the new version of GSP certification continues to be promoted in various regions However, it is reported that the pharmaceutical industry will not conduct GSP certification and GMP certification in the future What's going on here? In November 2014, the author asked the deputy inspector of a CFDA department for verification, and combined with relevant materials, sorted out the following: the GSP certificate and the business qualification certificate "two certificates in one" later to respond to the call of the state and reduce the power of administrative examination and approval, but the matters and standards required by the GSP are the same, so they should meet the GSP in advance Only by the standard can we get the operation qualification certificate, and we will also increase the flight inspection action at ordinary times The requirements are stricter The author analyzes that the national experience in the pharmaceutical industry will surely be used in the medical device management in the future, including GMP, GSP, and the provincial consumables bidding which is being continuously promoted Generally speaking, the process of standardization is the process of continuous improvement of concentration, the process of continuous shuffling of the industry, the process of life and death, all depending on the strategy, thinking and strategy of the enterprise Attachment: management standard of medical device operation quality (full text)