{"id":524181,"date":"2024-02-23T04:08:29","date_gmt":"2024-02-23T09:08:29","guid":{"rendered":"https:\/\/platohealth.ai\/medical-device-companies-annual-self-inspection-report-due-march-31\/"},"modified":"2024-02-23T10:05:27","modified_gmt":"2024-02-23T15:05:27","slug":"medical-device-companies-annual-self-inspection-report-due-march-31","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/medical-device-companies-annual-self-inspection-report-due-march-31\/","title":{"rendered":"Medical Device Companies Annual Self-Inspection Report Due March 31","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/02\/medical-device-companies-annual-self-inspection-report-due-march-31.jpg\" class=\"ff-og-image-inserted\"><\/div>\n<p>All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 \u201cMedical Device Supervision and Management Regulations\u201d.<\/p>\n<p>\u201cGuideline for Annual Self-Inspection Report on Medical Device Quality Management System\u201d published in March 2022 includes templates for self-inspection reports with specific content and instructions for documents compilation.<\/p>\n<p>The guideline also specifies that the content of the self-inspection report for each fiscal year should cover statistical data from January 1 to December 31 of that year. The report is required to be submitted to NMPA by March 31 of the following year.<\/p>\n<p>For our recorded webinar on \u201cPMS Key Updates \u2013 Enhanced Requirements of Post Market Surveillance Per Order 739\u201d, please click <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/chinameddevice.com\/download\/part-1-overview-pms-key-updates-enhanced-requirements-of-post-market-surveillance-per-order-739\/\"><strong>HERE<\/strong><\/a><\/p>\n<h4 class=\"wp-block-heading\" id=\"h-self-report-contents\">Self-Report Contents<\/h4>\n<p>1. Overview:<\/p>\n<p>(a) Basic Information on Production Activities:<\/p>\n<ul>\n<li>Include basic information about the registrant, record holder, and contracted manufacturing entities.<\/li>\n<li>Provide details such as names, addresses, production addresses, and production licenses (or record numbers).<\/li>\n<li>Include information on medical device product registration or record numbers, along with production details (including commissioned and contracted production).<\/li>\n<li>Specify the status of approved innovative products, prioritized approval products, and conditionally approved products.<\/li>\n<\/ul>\n<p>(b) Basic Information on Commissioned and Contracted Production:<\/p>\n<ul>\n<li>Outline details of commissioned and contracted production for medical devices already approved for market release.<\/li>\n<li>Include information on commissioned products, basic information about both the commissioning and contracted parties, quality agreements for commissioned production, and quality management for commissioned products.<\/li>\n<\/ul>\n<p>2. Annual Significant Changes:<\/p>\n<p>(a) Product Design Changes:<\/p>\n<ul>\n<li>Address design changes related to product safety, performance, and intended use.<\/li>\n<li>Report on changes completed through review, validation, and\/or confirmation.<\/li>\n<li>Submit annual product registration (or record) change details, including renewal situations.<\/li>\n<\/ul>\n<p>(b) Changes in Production and Inspection Areas, and Production and Inspection Equipment:<\/p>\n<ul>\n<li>Describe changes in the locations and layouts of production and inspection areas.<\/li>\n<li>Provide details on changes in production equipment for critical processes, inspection equipment for key raw materials, critical components, intermediate products, and finished products.<\/li>\n<\/ul>\n<p>(c) Changes in Product Manufacturing Processes:<\/p>\n<ul>\n<li>If changes occur in critical processes or special processes that impact previously validated or confirmed results, conduct revalidation or reconfirmation.<\/li>\n<li>Report situations where revalidation or reconfirmation is carried out for critical processes or special processes.<\/li>\n<\/ul>\n<p>(d) Significant Supplier Changes:<\/p>\n<ul>\n<li>Evaluate substantial changes in suppliers (manufacturers) of major raw materials, critical components, and significant service providers for sterilization, inspection, transportation (especially in cold chain transportation).<\/li>\n<\/ul>\n<p>3. Annual Operation of Quality Management System:<\/p>\n<p>(a) Organizational Structure and Personnel Training:<\/p>\n<ul>\n<li>Provide basic information about organizational structure, departmental setup, responsibilities, and personnel.<\/li>\n<li>Detail various training activities conducted by the company, including participation from the legal representative, company leaders, managerial representatives, and personnel influencing product quality.<\/li>\n<\/ul>\n<p>(b) Production Management and Quality Control:<\/p>\n<ul>\n<li>Describe basic conditions in production and inspection areas.<\/li>\n<li>Provide information on basic conditions of production equipment for critical processes, inspection equipment for major raw materials, critical components, intermediate products, and finished products, including calibration status.<\/li>\n<\/ul>\n<p>(c) Procurement Management:<\/p>\n<ul>\n<li>Include supplier audits and evaluations based on the \u201cMedical Device Manufacturing Enterprise Supplier Audit Guidelines,\u201d covering on-site and written audits and evaluations.<\/li>\n<\/ul>\n<p>(d) Customer Feedback:<\/p>\n<ul>\n<li>Describe the handling of customer complaints and the disposal of returned products.<\/li>\n<\/ul>\n<p>(e) Control of Non-Conforming Products:<\/p>\n<ul>\n<li>Detail the disposition of non-conforming products, product recalls, measures taken for non-conforming products found during random inspections, and the analysis of reasons.<\/li>\n<\/ul>\n<p>(f) Establishment of Traceability Systems:<\/p>\n<ul>\n<li>Report on the implementation of the Unique Device Identification (UDI) system.<\/li>\n<\/ul>\n<p>(g) Internal Audits and Management Reviews:<\/p>\n<ul>\n<li>Provide information on internal audits conducted during the year, including frequency, identified areas for improvement, and completion status.<\/li>\n<li>Detail the conduct of management reviews during the year, including frequency, identified areas for improvement, and completion status.<\/li>\n<\/ul>\n<p>(h) Monitoring and Reevaluation of Adverse Events:<\/p>\n<ul>\n<li>Collect information on adverse events, report as required, and conduct reevaluation activities, including the disposition of serious injury events and submission status of periodic risk assessment reports for medical devices.<\/li>\n<\/ul>\n<p>4. Other Matters:<\/p>\n<p>(a) Annual Regulatory or Certification Inspection:<\/p>\n<ul>\n<li>Detail various regulatory inspections conducted by domestic pharmaceutical supervision and administration departments throughout the year.<\/li>\n<li>Include information on inspection nature, timing, major issues found during inspection, conclusions, and rectification status.<\/li>\n<li>Report on annual inspections and certification results by other organizations.<\/li>\n<\/ul>\n<p>(b) Selected Medical Devices in Centralized Quantity Procurement at Various Levels:<\/p>\n<ul>\n<li>Provide information on the selection of medical devices in centralized quantity procurement at various levels.<\/li>\n<\/ul>\n<p>(c) Company Penalties by Pharmaceutical Supervision and Administration Departments:<\/p>\n<ul>\n<li>Include information on penalties imposed by pharmaceutical supervision and administration departments at various levels during the year.<\/li>\n<li>Report penalties imposed both in China and in the country (region) where the company is located (related to products exported to China)<\/li>\n<\/ul>\n<p>For the self-inspection report template for overseas manufacturers, please email us at <a href=\"mailto:info@ChinaMedDevice.com\">info@ChinaMedDevice.com<\/a>.<\/p>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. 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Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/chinameddevice.com\/annual-self-inspection\/\">https:\/\/chinameddevice.com\/annual-self-inspection\/<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 \u201cMedical Device Supervision and Management Regulations\u201d. \u201cGuideline for Annual Self-Inspection Report on Medical Device Quality Management System\u201d published in March 2022 includes templates for self-inspection reports with specific content and instructions for [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":524184,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/524181"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=524181"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/524181\/revisions"}],"predecessor-version":[{"id":524183,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/524181\/revisions\/524183"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/524184"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=524181"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=524181"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=524181"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}