{"id":245997,"date":"2021-03-23T16:30:48","date_gmt":"2021-03-23T11:00:48","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=245997"},"modified":"2021-07-30T10:05:18","modified_gmt":"2021-07-30T04:35:18","slug":"china-new-medical-device-regulations-effective-from-1st-june-2021","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/03\/23\/china-new-medical-device-regulations-effective-from-1st-june-2021\/","title":{"rendered":"China | New Medical Device Regulations, effective from 1st June, 2021"},"content":{"rendered":"<p style=\"text-align: justify;\">China has passed New Medical Device Regulations which shall come into force from 1<sup>st<\/sup> June, 2021. It regulates the supervision and administration of medical devices.<\/p>\n<p style=\"text-align: justify;\">The key features<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a> are:<\/p>\n<p>&nbsp;<\/p>\n<ul style=\"text-align: justify;\">\n<li>The classification and administration of medical devices will be done by state on the basis of level of risk. The national compulsory standards for medical devices should be met by all the products.<\/li>\n<li>The regulation aims to ensure the safety and effectiveness of medical devices, to protect people\u2019s health and safety, and to further develop the medical device industry.<\/li>\n<li>State will ensure that the supervision and administration will follow the principle of risk management, whole-course control, scientific supervision and shared governance by the whole society.<\/li>\n<li>Priority to be given to medical device innovation and encourage clinical applications to sustain high-quality development of the industry.<\/li>\n<li>The Regulation discusses an improved innovation system, support basic and application research of medical devices, and promote new technology. Enterprises are encouraged to cooperate with universities, scientific research institutions and medical institutions on studies and innovation. Medical device intellectual property copyrights will also be better protected.<\/li>\n<li>Medical device registrants should strengthen quality lifecycle management and be responsible for safety and effectiveness during the research, production and application process.<\/li>\n<li>The State will support and encourage medical institutions\u2019 clinical trials.<\/li>\n<li>Medical device registrants and manufacturers should build quality management systems suited to specific medical devices and continue to improve efficiency. They should strictly follow required technology standards and ensure product quality.<\/li>\n<li>Online shopping platform operators should require real-name registration from medical device dealers. Their business license and product registration should be reviewed.<\/li>\n<li>Inspection and quarantine authorities will inspect imported medical devices according to law. The drug supervision and administration department under the State Council should notify the inspection and quarantine authorities about imported medical devices\u2019 registration conditions.<\/li>\n<li>Advertisement of medical devices should be accurate and legitimate. The ads must be in compliance with registered instructions for use instead of containing false, exaggerated or misleading information. The ads should be censored by assigned provincial level authorities.<\/li>\n<li>The State should establish a system to monitor adverse events related to medical devices. The information network should be continuously improved. Professional inspectors should also be sent for more effective supervision.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000080;\">*Tanvi Singh, Editorial Assistant has put this story together.<\/span><\/p>\n<p style=\"text-align: justify;\"><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a>http:\/\/english.www.gov.cn\/policies\/latestreleases\/202103\/19\/content_WS60544e1dc6d0719374afb0e8.html<\/p>\n","protected":false},"excerpt":{"rendered":"<p>China has passed New Medical Device Regulations which shall come into force from 1st June, 2021. It regulates the supervision and administration <\/p>\n","protected":false},"author":121,"featured_media":245998,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14,4],"tags":[],"class_list":["post-245997","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-foreign","category-legislationupdates"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.4 (Yoast SEO v26.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>China | New Medical Device Regulations, effective from 1st June, 2021 | SCC Times<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.scconline.com\/blog\/post\/2021\/03\/23\/china-new-medical-device-regulations-effective-from-1st-june-2021\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"China | New Medical Device Regulations, effective from 1st June, 2021\" \/>\n<meta property=\"og:description\" content=\"China has passed New Medical Device Regulations which shall come into force from 1st June, 2021. 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Determining the Liability","author":"Bhumika Indulia","date":"February 10, 2025","format":false,"excerpt":"by Mahip Singh*, Samir Malik** and Maitri Singh***","rel":"","context":"In &quot;DSK Legal&quot;","block_context":{"text":"DSK Legal","link":"https:\/\/www.scconline.com\/blog\/post\/category\/experts_corner\/law-firm\/dsk-legal\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/02\/shared-image-8.jpeg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":103881,"url":"https:\/\/www.scconline.com\/blog\/post\/2017\/02\/05\/medical-devices-rules-2017-to-remove-regulatory-bottlenecks\/","url_meta":{"origin":245997,"position":1},"title":"Medical Devices Rules, 2017 to remove regulatory bottlenecks","author":"Saba","date":"February 5, 2017","format":false,"excerpt":"The Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.\u00a0 Only 15 categories of medical devices are, at present, regulated as drugs and to\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":255758,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/10\/16\/applicant-shall-submit-an-undertaking-for-registration-of-medical-device-vide-draft-medical-devices-amendment-rules-2021\/","url_meta":{"origin":245997,"position":2},"title":"Applicant shall submit an undertaking for registration of medical device vide Draft Medical Devices (Amendment) Rules, 2021","author":"Editor","date":"October 16, 2021","format":false,"excerpt":"The Ministry of Health and Family Welfare has notified the Draft Medical Devices (Amendment) Rules, 2021 vide notification dated October 12, 2021. The Draft Rules amend the Medical Devices Rules, 2017 in the following manner: The amendment provides that a person making an application for registration shall on or before\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":248978,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/06\/01\/eu-medical-devices-regulation-mdr-comes-into-force\/","url_meta":{"origin":245997,"position":3},"title":"EU Medical Devices Regulation (MDR) comes into force","author":"Bhumika Indulia","date":"June 1, 2021","format":false,"excerpt":"On May 26, 2021 the EU Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. The Regulation introduces various changes which will have an effect on the supply chain for medical devices. \u00a0 Mr. Murali Neelakantan says that \"MDR requires Pharma companies to display unique device identification\u2026","rel":"","context":"In &quot;Foreign Legislation&quot;","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":253212,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/08\/25\/cdsco-issues-classification-of-medical-devices-pertaining-to-dental-under-medical-devices-rules-2017\/","url_meta":{"origin":245997,"position":4},"title":"CDSCO issues classification of Medical Devices pertaining to Dental under Medical Devices Rules, 2017","author":"Bhumika Indulia","date":"August 25, 2021","format":false,"excerpt":"On August 23, 2021, the Central Drugs Standard Control Organisation (CDSCO) has issued Classification of Medical Devices pertaining to Dental under the provisions of Medical Devices Rules, 2017. The medical devices, based on the intended use, risk associated with the devices and other parameters. The list of medical devices (mentioned\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":301031,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/09\/07\/delhi-high-court-upholds-centre-decision-medical-devices-ambit-drugs-drug-regulatory-framework-legal-news\/","url_meta":{"origin":245997,"position":5},"title":"Delhi High Court upholds Centre decision to bring all medical devices under the ambit of \u2018drug\u2019 under Drugs and Cosmetics Act, 1940","author":"Arunima","date":"September 7, 2023","format":false,"excerpt":"The larger public interest, which concerns patient safety, requires that all medical devices be brought within a regulatory regime. One cannot quibble with the intent, purpose and object with which the impugned notifications have been issued.","rel":"","context":"In &quot;Case Briefs&quot;","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"delhi high court","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/delhi-high-court.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/delhi-high-court.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/delhi-high-court.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/delhi-high-court.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/245997","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/121"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=245997"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/245997\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/245998"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=245997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=245997"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=245997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}