A large number of medical devices are unqualified in random inspections, and equipment companies need to accelerate the improvement of quality and management systems

Medical equipment is related to the health and life safety of the people and the overall situation of the country's economic and social development
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According to statistics, there are currently more than 25,000 medical device manufacturers and more than 897,000 operating companies across the country
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In addition, in 2019, the national medical device main business income has reached more than 720 billion yuan, accounting for about 20% of the global medical device market
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It is worth noting that with the continuous development of the economy and the increasing demand for health, while China's medical device market will usher in huge development opportunities, the domestic supervision of the medical device industry is also continuously tightening
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Since the beginning of this year, relevant domestic departments have conducted random inspections of medical device companies very frequently
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On December 22, the State Food and Drug Administration Announcement (No.
5) (No.
105 of 2021) on the release of the results of the national medical device supervision and sampling, stated that in order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical device products, The National Medical Products Administration organized and organized product quality supervision and random inspections on 18 varieties of γ-glutamyltransferase assay reagents (kits), semiconductor laser treatment machines, and nasal endoscopes.
A total of 39 batches (sets) of products were not in compliance.
Standard requirements
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It is reported that for the above-mentioned non-compliant products found in random inspections, the State Food and Drug Administration has required the provincial drug supervision and administration department of the company's location to comply with the "Regulations on the Supervision and Administration of Medical Devices", the "Measures for the Supervision and Administration of Medical Device Production" and the "Medical Device Recall Management" The Measures and others require that administrative decisions be made in a timely manner and announced to the public
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At the same time, companies are also required to conduct risk assessments on products that do not meet the standard requirements in random inspections, and determine the recall level based on the severity of medical device defects, actively recall products and disclose recall information
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On December 20, Henan Provincial Drug Administration issued a medical device quality announcement (No.
8 of 2021)
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According to the announcement, the Henan Provincial Drug Administration organized local regulatory agencies to conduct random inspections of medical device products across the province
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Among them, there are 7 batches of products that do not meet the requirements of the standard, including infrared forehead thermometers, non-contact infrared thermometers, magnetic therapy stickers, etc.
; unqualified items involve instruction manuals, technical specifications, magnetic core magnetic field strength, etc.

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At present, for the above-mentioned products that do not meet the standards and regulations, the Henan Provincial Drug Administration has handed over to the supervisory and administrative department where the company is located according to the procedures for investigation and disposal in accordance with the law
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The industry believes that, from the above point of view, with the implementation of the "Regulations on the Supervision and Administration of Medical Devices", medical device manufacturers have ushered in an era of strong supervision
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In the future, such random inspections will become the norm
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In this context, industry insiders have proposed that companies should strictly control the procurement of raw materials, select good suppliers, ensure product quality from the source, prevent the risk of product quality problems; strictly implement and supervise product release and control procedures
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In addition, it is also necessary to focus on the implementation of the quality policy/objective suitability quality objectives; product conformity and stability; data collection, analysis, and utilization; the effectiveness of continuous improvement measures; the documented system's compliance with standards ; file degree system implementation
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In general, under the situation of ever-increasing stricter supervision and more normalized random inspections, only compliance development can be a healthier, high-quality development for machinery companies
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In the future, in the context of compliance development, it is expected that a number of local medical device manufacturers with core technologies will emerge quickly, and a number of multinational medical device giants will also take root in China, jointly contributing to the high-quality development of the domestic medical device industry
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