The medical device company started its self-inspection, and the new catalogue also came.
Recently, the CFDA issued the "Notice on the Implementation of the Quality Management Regulations for the Production of Medical Devices in the First and Second Classes of Medical Device Manufacturers" (hereinafter referred to as the Notice). The "Notice" emphasizes that all medical treatments will be available from January 1, 2018. Equipment manufacturers should meet the requirements of the "Quality Management Standards for Medical Device Production". The "Notice" clarifies that the first-class and second-class medical device manufacturing enterprises shall fully carry out the quality management system in accordance with the requirements of Article 24 of the Regulations in accordance with the requirements of the "Quality Management Standards for Medical Device Production" and related appendices. If it is still unable to meet the requirements of the "Quality Management Regulations for Medical Device Production" from January 1, 2018, it shall stop production and report to the local municipal food and drug supervision department. At the same time, the "Notice" requires that, starting from January 1, 2018, the provincial food and drug supervision departments shall organize the first and second categories in the administrative region in strict accordance with the requirements of the "Quality Management Regulations for Medical Device Production" and related appendices. Class medical device manufacturers carry out supervision and inspection. In accordance with the "Regulations on the Classification and Supervision of Medical Device Manufacturing Enterprises" (Food and Drug Administration Supervision [2014] No. 234) on the basis of daily supervision, according to the "13th Five-Year National Drug Safety Plan", the first category The second type of medical device manufacturing enterprises shall, according to the principle of “double randomness and opennessâ€, select not less than 50% of the enterprises to conduct inspections each year. At the same time, it is necessary to highlight the risk management and problem orientation, and must check the complaints and reports, and the unqualified inspections to eliminate the hidden dangers of product quality and safety. In the supervision and inspection, if the production enterprise fails to establish a quality management system in accordance with the provisions of the Regulations and maintains effective operation, it shall be punished in accordance with Article 66 of the Regulations; the quality management system does not meet the requirements and is not in accordance with the Regulations. Where rectification, production stoppage or reporting are required, penalties shall be imposed in accordance with Article 67 of the Regulations, and the high-pressure situation of the implementation of the "Regulations" shall be formed through public inspection results and exposure of illegal and illegal enterprises, and the production enterprises shall be urged to implement the subject responsibility. Article 66 In any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall order it to correct and confiscate the medical equipment illegally produced, operated or used; the amount of medical equipment illegally produced, operated or used is insufficient. 10,000 yuan, and a fine of 20,000 yuan to 50,000 yuan; the value of goods is more than 10,000 yuan, and the amount of goods is more than 5 times more than 10 times the fine; if the circumstances are serious, ordered to suspend production and business, until the original The issuing department revokes the medical device registration certificate, medical device production license, and medical device business license (1) Producing, operating, or using medical devices that do not meet the mandatory standards or do not meet the technical requirements for products registered or filed; (2) The medical device manufacturing enterprise fails to organize production according to the technical requirements of the registered or filed products, or fails to establish a quality management system in accordance with the provisions of these Regulations and maintain effective operation; (3) Operating or using non-qualified documents, medical equipment that has expired, expired or eliminated, or using medical equipment that is not legally registered; (4) After the food and drug supervision and administration department orders it to carry out a recall or stop operations in accordance with the provisions of these Regulations, it still refuses to recall or stop operating medical equipment; (5) Entrusting enterprises that do not have the conditions stipulated in these Regulations to produce medical devices, or failing to manage the production activities of the trustee. Article 67 In any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall order it to make corrections and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and suspend business until the original certificate is issued. Department revoked medical device production license, medical device business license (1) The production conditions of the medical device manufacturing enterprise have changed, no longer meet the requirements of the medical device quality management system, and have not been rectified, stopped, or reported in accordance with the provisions of these Regulations; (2) The production and business instructions and labels that do not comply with the medical equipment specified in these Regulations; (3) failing to transport or store medical devices in accordance with the medical device instructions and labeling requirements; (4) Transfer of medical devices that are in use, expired, expired, or rejected for inspection. Finally, the CFDA has clarified that it will continue to strengthen the flight inspections for third-class medical device manufacturers and complaints and reports, and conduct flight inspections of Class I and Class II medical device manufacturers in a timely manner, as well as The supervision and spot check on the implementation of the "Quality Management Standards for Medical Device Production", the problems and suggestions encountered by the local food and drug supervision departments in the implementation should be promptly reported to the Medical Device Supervision Department of the General Administration. At the same time, just yesterday (September 4th), the CFDA officially released the "Medical Device Classification Catalogue" (hereinafter referred to as the catalogue), which is divided into 22 sub-directories according to technical professional and clinical use characteristics, sub-directories consist of one Composed of the product category, the secondary product category, the product description, the intended use, the product name example and the management category, and will be implemented on August 1, 2018. CFDA said that the framework and content of the new Catalogue will be greatly adjusted, which will affect the registration, production, operation and use of medical devices. Circular of the General Administration of Autonomous Region on the Implementation of the Catalogue of Medical Devices (No. 143 of 2017) In order to implement the "Regulations on the Supervision and Administration of Medical Devices" and the "Opinions of the State Council on Reforming the Examination and Approval System for Medical Devices for Drugs" (Guo Fa [2015] No. 44), the State Food and Drug Administration issued the "August 31, 2017" The Catalogue of Medical Devices (hereinafter referred to as the new "Category") will be implemented from August 1, 2018. In order to do a good job in the implementation of the new Catalogue, the relevant matters are hereby notified as follows: I. General description of the new Catalogue (1) The new Catalogue is divided into 22 sub-categories according to the technical specialty and clinical use characteristics. The sub-directories are composed of the primary product category, the secondary product category, the product description, the intended use, the product name example and the management category. When judging the management category of the product, it should be based on the actual situation of the product, combined with the product description, intended use and product name in the new Catalogue, for comprehensive judgment. The product description and intended use are used to determine the management category of the product, and do not represent relevant A complete description of the product registration content. Registered applicants may use the name of the new Catalogue, or draft a product name in accordance with the General Rules for the Naming of Medical Devices (Order No. 19 of the State Food and Drug Administration). (2) The new "Catalogue Catalogue" does not include in vitro diagnostic reagents. The in vitro diagnostic reagent product categories shall be in accordance with the "Regulations on the Registration of In Vitro Diagnostic Reagents" (Order No. 5 of the State Food and Drug Administration, No. 5 Order), "In Vitro Diagnostics" The Reagent Registration Management Amendment (General Directorate Order No. 30, hereinafter referred to as Order No. 30), the "6840 In Vitro Diagnostic Reagent Classification Sub-category (2013 Edition)" and the subsequent publication of the classification definition document on the classification of in vitro diagnostic reagents It is determined that the classification code continues to be extended to 6840. (3) The new "Catalogue Catalogue" does not include packaged products, and the categories of packaged products shall be in accordance with the "Regulations on the Classification of Medical Devices" (Order No. 15 of the State Food and Drug Administration), Order No. 5, Order 30, etc. Make a decision.
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