In order to guide medical device manufacturers to do quality management in accordance with the technical requirements of registered or filed products, strengthen quality control during procurement, production and inspection, strictly release finished medical device products, and improve product quality assurance level, January 4, CFDA According to the Measures for the Supervision and Administration of Medical Device Production (Order No. 7 of the State Food and Drug Administration) and the Code for Quality Management of Medical Device Production (State Food and Drug Administration Announcement No. 64 of 2014), State Food and Drug Administration The General Administration of the People's Republic of China has formulated the "Guidelines for Quality Control and Finished Release of Medical Device Manufacturing Enterprises", the full text of which is as follows:
Medical Device Manufacturing Enterprise Quality Control and Finished Product Release Guide
The medical device manufacturing enterprise (hereinafter referred to as the enterprise) shall, in accordance with the requirements of the "Quality Management Standards for Medical Device Production" (No. 64 of the State Food and Drug Administration announced in 2014) and its appendix, strengthen the whole process of product realization, especially procurement and Quality control of the production process and management of finished product release to ensure that the released medical devices meet mandatory standards and technical requirements for registered or filed products.
First, the scope of application
The quality control referred to in this guide includes the verification/confirmation/monitoring/measurement/inspection/test activities and quality related to the main raw materials, parts, accessories, intermediates, finished products, primary packaging materials, labels, etc. related to the product. Management also includes verification/confirmation/monitoring/measurement/inspection/test activities and quality management related to the production process, especially related to key processes and special processes in the production process.
The release of finished products referred to in this guide does not include the release procedures for purchased items and intermediates. Enterprises can refer to the principle of release of finished medical devices and make their own release procedures for purchased and intermediate products.
This guide does not include quality control and management of the environment, facilities, equipment and related processes related to production and inspection, such as production, inspection of environmental monitoring in clean areas, auxiliary process water, quality management of auxiliary process gas. If the above quality control and its management activities are directly related to the requirements for purchased goods, intermediate goods or finished products, this guide considers it to be part of the requirements related to the procurement of goods, intermediate goods or finished products.
Second, quality control and finished product release
The enterprise shall determine the whole process of product realization according to the requirements of regulations, risk management requirements, product technical requirements, product characteristics, production scale, process characteristics, quality management capabilities, etc., especially the verification/confirmation/monitoring/measurement of procurement and production processes. Inspection/test process and requirements.
Enterprises should aim at the procurement of goods, intermediate products and finished products and related processes, after the completion of the design and development of medical devices, especially after the completion of the design conversion, the output of the inspection system, the process inspection procedures and the finished product inspection procedures, etc. Documents to guide the realization of the whole process of the product, especially the quality control of the procurement and production process and the release of the finished product, to ensure the use of the purchased items that meet the requirements, to transfer the intermediate products that meet the requirements, and to release the finished products that meet the requirements.
Shanghai Rocatti Biotechnology Co., Ltd. is a professional enterprise of rehabilitation and medical device products with sales and service as the main body. Since its establishment, the company has been committed to the development of medical devices. Its products involve the production of epidemic prevention materials such as gynecology (obstetrics), Urology, neurosurgery, kn95 medical protective masks, daily use flat masks, and the research and development of total nutrition slimming food. It can provide a complete range of first, second and third class medical device configuration schemes for general hospitals and specialized hospitals.
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Shanghai Rocatti Biotechnology Co.,Ltd , https://www.ljdmedicals.com