The General Administration issued a document: Strengthening the quality supervision of IVD reagents and cracking down on illegal activities

Release date: 2015-04-10

On April 7, the General Office of the State Food and Drug Administration issued the Notice on the Quality Assessment and Comprehensive Management Work Plan for In Vitro Diagnostic Reagents.

The "In vitro Diagnostic Reagent Quality Assessment and Comprehensive Treatment Work Plan" (hereinafter referred to as "Program") aims to comprehensively understand the quality and safety status of in vitro diagnostic reagents, further standardize the production, operation and use order of in vitro diagnostic reagents, strengthen supervision and severely crack down on illegal and illegal regulations. The behavior is to ensure the safety of the public.

The "Program" highlights both quality assessment and comprehensive governance. Focus on "three synchronizations":

Simultaneously carry out "strike, prevent, and build", crack down on illegal and illegal behaviors, comprehensively prevent potential risks of quality and safety risks, and establish and improve long-term supervision mechanisms;

Simultaneously carry out the activities of in vitro diagnostic reagent quality, strengthen scientific popularization, and create a social co-processing atmosphere;

Specialized training will be carried out simultaneously to improve the ability of grassroots supervisors to supervise in vitro diagnostic reagents.

The implementation of the "Program" will greatly standardize the current IVD market, from quality assessment to comprehensive management, and control the quality of the IVD market, thus ensuring the safety of consumers using IVD devices; It also helps to establish a domestic brand of IVD medical equipment products to a certain extent, paving the way for the future competitiveness of domestic IVD medical equipment brand.

The specific provisions are as follows:

In vitro diagnostic reagent quality assessment and comprehensive treatment work program

In order to fully understand the quality and safety status of in vitro diagnostic reagents, further standardize the production, operation and use order of in vitro diagnostic reagents, strengthen supervision and severely crack down on violations of laws and regulations, this work plan is specially formulated.

I. Guiding ideology In vitro diagnostic reagents involve the whole process of diagnosis, treatment, treatment, treatment evaluation, and therapeutic evaluation. The demand is large and directly affects the vital interests of the people. In order to find out the hidden dangers of in vitro diagnostic reagent products, understand the quality and safety status, further standardize the order of production, operation and use, severely crack down on violations of laws and regulations, ensure the safety and effectiveness of public safety, and focus on the quality assessment and comprehensive management of in vitro diagnostic reagents.

Second, the work objectives are to take risk investigation, quality investigation, special investigation and special rectification, etc., to combine quality assessment and comprehensive management, through quality assessment to achieve the purpose of finding out the bottom, identifying problems, and proposing regulatory measures, through comprehensive management The goal of step-by-step rectification, comprehensive policy, and the establishment of a long-term regulatory mechanism will continue to consolidate the new mode of special management of medical device supervision, which is “multi-participation, prevention and combination, construction and integration, public benefit, and industry development”.

The quality assessment and comprehensive governance focus on “three synchronizations”: simultaneously launch “strike, prevent and build”, severely crack down on illegal and illegal behaviors, comprehensively prevent potential risks of quality and safety risks, establish and improve long-term regulatory mechanisms, and simultaneously develop quality of in vitro diagnostic reagents. Miles activities, strengthen popular science propaganda, create a social co-governing atmosphere; simultaneously carry out special training to improve the supervision ability of grassroots supervisors on in vitro diagnostic reagents.

Third, specific measures (1) to carry out risk investigation. Conduct "100-day risk investigation" on the production, management and use of in vitro diagnostic reagents, find out the base of in vitro diagnostic reagent production and operation enterprises (including import distributors), understand the basic situation of in vitro diagnostic reagents used in hospitals, and establish a sound regulatory file. . The risk hazard found in the investigation shall be immediately taken into prevention and control measures, and the production and operation enterprises and hospitals shall be urged to implement rectification, deepen hidden rules, prevent regional and systemic risks, and investigate and investigate illegal violations, and investigate and investigate according to law. Typical cases should be publicly exposed.

(2) Carry out special rectification. Specialized rectification is carried out in the production, management and use of in vitro diagnostic reagents. In the production process, we will focus on rectifying non-compliance of raw materials, non-compliance with water preparation, unauthorized changes in production processes, and unstable product quality. In the business process, we will focus on rectifying unlicensed operations, operating unlicensed products, and storing and transporting cold chains. Compliance, labeling, non-compliance and other aspects; in the use of links, focus on rectification of hospital use of unlicensed products, use of expired products, storage conditions are not in compliance, labeling is not in compliance with other aspects.

(3) Conducting quality surveys. For some in vitro diagnostic reagents with a large amount of clinical use and a wide range, the supervision and sampling tests are carried out in the production, operation and use to improve the discovery rate of in vitro diagnostic reagent products. Select some products to carry out risk monitoring to find potential problems and risks in the raw materials, quality stability or uniformity.

(4) Conducting special investigations. In view of some outstanding problems in in vitro diagnostic reagents, the organization combed the conformity and applicability of existing in vitro diagnostic reagent product standards, learned about the research and clinical use of in vitro diagnostic reagents in hospitals, and investigated some raw materials for the production of in vitro diagnostic reagents. Source, check the risk of hidden dangers, and propose relevant measures in a targeted manner.

(5) Carry out the activity of “In Vitro Diagnostic Reagent Quality Miles”. Organize the mainstream media to in-depth in vitro diagnostic reagent production and management enterprises, hospitals, testing institutions and regulatory departments, carry out large-scale research and reporting activities, publicize typical enterprises, and expose violations of laws and regulations. Combine the quality of Miles activities, organize the preparation of in-vitro diagnostic reagents, and carry out the activities of in vitro diagnostic reagent manufacturers, inspection agencies and users. Open the daily knowledge and practical knowledge of in vitro diagnostic reagents through TV, network and Weibo. To guide the public's rational cognition.

(6) Carry out special training. Organize the supervision and regulation of in vitro diagnostic reagents and relevant professional knowledge of grassroots supervisors, unify regulatory standards, standardize regulatory behaviors, and avoid the phenomenon of lax enforcement and law enforcement.

(7) Organizing investigation and handling of cases. Strictly implement the "Regulations on the Supervision and Administration of Medical Devices" and other laws and regulations, do a good job in the connection between daily supervision and inspection and law enforcement, and deepen the expansion of the illegal clues found in the supervision, and form a case to be investigated in a timely manner. Anyone suspected of committing a crime shall be transferred to the public security organ for criminal responsibility. For products with potential quality and safety hazards, sales and use shall be stopped, and if necessary, the company shall be ordered to recall and supervise the destruction. For the violation of laws and regulations of the hospital, the health and family planning department at the same level shall be notified.

(8) Establish a long-term mechanism. Through quality assessment and comprehensive management, we will further improve the supervision system of each link, and formulate guidelines for on-site inspection of in vitro diagnostic reagent production enterprises and quality management guidelines for key links. At the same time, summarizing effective empirical practices and forming a long-term regulatory mechanism.

IV. Timeline (1) In early April 2015, the General Administration of the People's Republic of China held a video conference on the quality assessment and comprehensive management of in vitro diagnostic reagents.

(2) The food and drug supervision departments of all provinces (autonomous regions and municipalities) shall formulate specific implementation plans in light of the actual conditions of their respective administrative regions, and submit the specific implementation plan to the Equipment Supervision Department of the General Administration before April 19.

(3) From mid-April to mid-July, the food and drug supervision departments of all provinces (autonomous regions and municipalities) organized the “100-day risk investigation” and special rectification for the in vitro diagnostic reagent production and operation enterprises and hospitals in the administrative region. Before July 16, the summary report of local risk investigation and special rectification will be submitted to the Equipment Supervision Department of the General Administration.

(IV) From April to September, the General Administration of the State Council organized relevant food and drug regulatory authorities and testing agencies to conduct quality investigations of in vitro diagnostic reagents, and announced the results of supervision and sampling before the end of November.

(V) From April to May, the General Administration organized relevant units to carry out special investigations and formed a research report in June.

(6) From April to June, the General Administration of the People's Republic of China instructed the relevant units to carry out the “In Vitro Diagnostic Reagent Quality Miles” activity. During the event, the Equipment Supervision Department of the General Administration and the food and drug supervision departments of various localities organized the open day activities of in vitro diagnostic reagent production enterprises, testing institutions and users.

(VII) In late May, the Equipment Supervision Department of the General Administration of the People's Republic of China organized an exchange meeting on risk investigation.

(8) In late July, the General Administration of the People's Republic of China organized an inspection team to supervise the comprehensive management of food and drug supervision departments of some provinces (autonomous regions and municipalities). The food and drug supervision departments of all provinces (autonomous regions and municipalities) shall organize supervision and inspection in due course according to the local work.

(9) In November, completed the quality assessment and comprehensive management work report of in vitro diagnostic reagents.

V. Job requirements (1) Strengthen organizational leadership. The food and drug supervision departments of all provinces (autonomous regions and municipalities) shall, in conjunction with the actual conditions of their respective administrative regions, establish a leading organization, clarify the division of responsibilities, implement responsible departments, and formulate specific implementation plans to ensure that the work has rules to follow. Local food and drug supervision departments at all levels must conscientiously organize and implement according to the specific implementation plan, and grasp the first-level level and implement it at all levels. The food and drug supervision departments and units of the relevant provinces (autonomous regions and municipalities) shall actively cooperate with the quality surveys, special investigations, quality operations and training publicity organized by the Equipment Supervision Department of the General Administration of the People's Republic of China.

(2) Do a good job in overall coordination. Local food and drug supervision departments at all levels shall, in accordance with the key work of the General Administration in 2015, combined with the actual situation of local supervision, and through the quality assessment and comprehensive management of in vitro diagnostic reagents, combine the comprehensive investigation of potential risks and focus on the rectification of key links, and will supervise the sampling and risk. The combination of monitoring and special investigations, rationally arrange the supervision resources and time schedule, and coordinate the special treatment and key rectification work throughout the year.

(3) Pay attention to the effectiveness of work. Local food and drug supervision departments at all levels must conscientiously and conscientiously do a good job in the quality assessment and comprehensive management of in vitro diagnostic reagents. Risk investigation should comprehensively find out the situation and identify hidden dangers. Special rectification should carry out in-depth inspections on key issues and implement rectification measures one by one, and investigate and deal with violations of laws and regulations in a timely manner. At the same time, we must pay attention to establishing a long-term regulatory mechanism, promote the improvement of the ability of grassroots supervisors, and actively carry out popular science promotion activities to create a good social atmosphere.

(4) Do a good job of submitting information. The food and drug supervision departments of all provinces (autonomous regions and municipalities) shall submit relevant work progress, main results, major cases, and important problems encountered in the work to the Equipment Supervision Department of the General Administration in a timely manner, and submit the summary report according to the prescribed time. At the same time, the food and drug supervision and administration departments of all provinces (autonomous regions and municipalities) shall regulate the release of news, and release major information before reporting to the General Administration.

Source: Medical Device Innovation Network

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