The State Council inspection team has entered the medical device company

Pharmaceutical Network reported on September 26th that the state is severely punishing violations in multiple aspects of medical device purchasing, sales, taxation, etc.

　　Violators will be eliminated, and punishment will be intensified.

　　On September 24th, the State Council's Institutional Reform Office released the "State Council Briefing on Deepening the Reform of the Medical and Health System."PharmaceuticalFollowing the notice on several opinions regarding reforms in the pharmaceutical field issued by the General Office of the State Council, various localities and relevant departments have earnestly implemented the deployment, cooperated closely, and focused on the following points:

　　First, strict investigations began at the source of the production process. Simultaneously, in terms of the circulation process, enterprises are encouraged to merge and reorganize. For example, large enterprises such as China National Pharmaceutical Group, China Resources Pharmaceutical Group, and Shanghai Pharmaceutical Group are developing modern warehousing and logistics, accelerating the construction of pharmaceutical storage and transportation management and system information.

　　Regarding the medical device sector, the National Medical Products Administration specifically pointed out the need to rectify prominent problems in the circulation field, focusing on investigating and punishing illegal and irregular activities in the medical device purchasing and sales field to effectively maintain a fair and competitive market order.

　　At the same time, multiple departments are jointly cleaning up the industry environment.

　　In terms of reporting and complaints, the State Administration for Market Regulation will continue to increase the intensity of market supervision in the pharmaceutical field, making the price supervision platform reporting and complaint channels more accessible, and carefully and properly handling price reports and complaints in the medical and health field.

　　Regarding tax violations, the State Taxation Administration will conduct a special rectification of tax in the pharmaceutical industry to curb the chaos of false invoicing, cashing out, and tax evasion in the pharmaceutical industry.

　　The Ministry of Public Security will severely crack down on crimes of falsely issuing VAT invoices in the medical device field. Bad behavior will be linked to the credit system. The National Development and Reform Commission and multiple departments jointly signed a memorandum of cooperation to implement joint punishment against seriously illegal and untrustworthy entities in the pharmaceutical field.

　　Therefore, whether it is medical device manufacturers, distributors,agentsor merchants, the intensity of punishing violations has increased unprecedentedly.

　　Medical DevicesSpecialized inspection teams, establishing

　　Enterenterprisesto investigate violations.

　　At the end of July, the General Office of the State Council issued a document, "Opinions on Establishing a Professionalized and Specialized Team of Pharmaceutical Inspectors," which involves inspection trends in the medical device field.

　　The document emphasizes that professionalized and specialized medical device inspectors are personnel who have been identified by drug regulatory departments and who legally conduct compliance confirmation and risk assessment of the places and activities of managed entities engaged in drug research and development and production. They are an important support for strengthening supervision and ensuring safety.

　　The "Opinions" clearly states that the state will adhere to strict prevention at the source, strict management during the process, and strict risk control, strengthen safety supervision and inspection, and effectively guarantee the safety of medical device use for the people.

　　The document stipulates that in terms of inspection systems and mechanisms, there will be national and provincial inspection teams, equipped with full-time inspectors who meet the requirements of inspection work.

　　Specifically, the State Council's regulatory departments will mainly conduct on-site inspections of the medical device R&D process, and will conduct compliance checks on the implementation of medical device clinical trial quality management specifications. They will also undertake on-site inspections abroad and major inspections of the production process.

　　Provincial drug regulatory departments will mainly conduct on-site inspections of the medical device production process and compliance checks on the implementation of relevant production quality management specifications.

　　The document also specifically emphasizes that provincial departments will also conduct relevant on-site inspections of medical device wholesale enterprises, retail chain headquarters, and third-party platforms for Internet sales.

　　At the same time, it requires that the work will fully implement "double random, one open" supervision, accelerate the promotion of intelligent supervision based on cloud computing, big data, and "Internet +" information technology, and improve the efficiency of supervision and inspection.

　　It can be seen that the state has made deployments for various aspects and channels in the medical device field.

　　These are the key points of medical device supervision and management.

　　At the beginning of this year, the Medical Device Supervision Department of the National Medical Products Administration announced its work tasks for this year. Currently, two-thirds of the 2019 schedule has passed, and key work is still ongoing.

　　First, improve the regulatory system for medical devices. Complete the relevant work on the revision of the Medical Device Regulations, carry out the revision of relevant departmental regulations, and study and improve relevant specifications and systems to promote "streamlining administration, delegating power, and improving services" reform.

　　Second, effectively strengthen risk management. Organize and carry out risk safety nature analysis, coordinate and organize relevant departments to carry out relevant risk analysis work, compile an annual report on the quality and safety situation analysis, analyze the relevant situation in some key products and key industries, and strengthen regulatory work throughout the system.

　　Third, strengthen production supervision and inspection. This includes strengthening supervision and inspection, conducting flying inspections, conducting special inspections, continuing to conduct overseas inspections, and strengthening risk investigation and control of key regions, key enterprises, and key products.

　　Fourth, strengthen the supervision of operation and use. Guide municipal and county-level market supervision departments to carry out inspection work in the operation and use links. Strengthen the supervision of online transactions, organize and carry out a medical device "clean-up" operation, and promote the implementation of network monitoring and disposal responsibilities by regulatory departments at all levels.

　　Fifth, strengthen adverse event monitoring. Organize and implement the management methods for adverse event monitoring and re-evaluation, and do a good job in key monitoring. The National Medical Products Administration will continue to organize key monitoring of 100 medical device varieties, and in accordance with the requirements of the "Thirteenth Five-Year" NationalPharmaceuticalSafety Plan, complete the key monitoring work of 100 medical device varieties by the end of 2020.

　　Sixth, do a good job in supervision and spot checks. In conjunction with the new institutional adjustments and changes in responsibilities, appropriately revise and adjust some of the procedures for inspection work; organize supervision and spot checks, and do a good job in analyzing, using, and handling the results of inspection quality, including deepening the analysis of inspection data and doing a good job in relevant information disclosure and reporting.