Promoting the implementation of quality management standards for medical device production, strengthening supervision and management of medical device production, guiding supervisory departments to conduct on-the-spot inspection and evaluation of inspection results in accordance with the "Quality Management Standards for Medical Device Production" and its related appendices for medical device manufacturers, and in accordance with the "Quality Management Standards for Medical Device Production" and The State Food and Drug Administration has formulated the Guiding Principles for on-site Inspection of Medical Device Production Quality Management Standards, the Guiding Principles for on-site Inspection of Sterile Medical Devices, and the Guidance for on-site Inspection of Implantable Medical Devices. "Principles", "medical device production quality management standard, in vitro diagnostic reagent on-site inspection guidelines". The Guiding Principles are used to guide the supervisory departments to conduct on-site inspections and to assess the results of inspections of the Medical Device Manufacturing Quality Management Standards and the related appendices for the medical device manufacturing enterprises. They are applicable to on-site inspections of the registration of medical devices, on-site inspections of the production license of medical devices (including continuation or alteration) and inspections according to work requirements. All kinds of supervision and inspection for medical device manufacturers should be carried out.
With the promulgation of the Standards for the Quality Control of Medical Device Production and the corresponding inspection guidelines, it marks a new enterprise with the Regulations on the Supervision and Administration of Medical Devices as its core, the measures for the supervision and administration of medical device production, the catalogue of state key supervision and administration of medical devices, the catalogue of prohibited entrusted production of medical devices and the enterprise for the production of medical devices. On the basis of regulations and regulations, such as regulations on classification and grading management of industries, the normative documents such as the Norms, Guiding Principles for Standardized Inspection, Appendixes to the Norms for Sterility, Implantable Medical Devices, in Vitro Diagnostic Reagents, and Guiding Principles for Inspection are adopted as the means, and the guideline documents such as Supplier Audit Guidelines and Water Making Link Guidelines for The regulatory system of supplementary medical device production links has been formed and is constantly improving.