{"id":5104,"date":"2021-12-15T10:15:48","date_gmt":"2021-12-15T10:15:48","guid":{"rendered":"https:\/\/www.elitestage.cn\/?p=5104"},"modified":"2023-03-29T11:28:24","modified_gmt":"2023-03-29T11:28:24","slug":"chinas-medical-devices-industry-key-market-entry-consideration","status":"publish","type":"post","link":"https:\/\/www.elitestage.cn\/de\/chinas-medical-devices-industry-key-market-entry-consideration\/","title":{"rendered":"China\u2019s Medical Devices: Industry Key Market Entry Consideration"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-5105\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1.jpg\" alt=\"\" width=\"1080\" height=\"866\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1.jpg 1080w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-300x241.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-1024x821.jpg 1024w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-768x616.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-16x12.jpg 16w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-80x64.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-620x497.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-460x369.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/1-365x293.jpg 365w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/><\/p>\n<p>China healthcare industry is currently ranked the<strong>\u00a0second largest\u00a0<\/strong>in the world behind the US.<\/p>\n<p>The market has\u00a0<strong>grown at a consistently rapid rate<\/strong><strong>\u00a0in the past five years,<\/strong>\u00a0and in 2019, the market reached RMB 7.82 trillion, an increase of\u00a0<strong>10 percent<\/strong>\u00a0when compared to that from the previous year.<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-5106\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2.jpg\" alt=\"\" width=\"900\" height=\"762\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2.jpg 900w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-300x254.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-768x650.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-14x12.jpg 14w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-80x68.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-620x525.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-460x389.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical2-365x309.jpg 365w\" sizes=\"(max-width: 900px) 100vw, 900px\" loading=\"lazy\" \/><\/p>\n<p>Despite this, the market remains relatively undeveloped, with China&#8217;s health expenditure \u2013 including pharmaceuticals, medical devices, distribution, hospital, pharmacies and insurance \u2013 accounting for only 7.12 percent of the total GDP in 2020 (though this figure is an increase from 2018&#8217;s level of 6.57 percent), while the US reached 18 percent in the same year.<\/p>\n<p>Thus, the market presents\u00a0<strong>considerable opportunities\u00a0<\/strong>for growth, particularly as the Chinese government has more recently\u00a0<strong>laid out multiple initiatives<\/strong>\u00a0to support long-term growth and innovation in healthcare delivery, and healthcare will likely feature more heavily in the<strong>\u00a014th Five Year Plan\u00a0<\/strong>(covering 2021-25) than it did in the 13th Five Year Plan.<\/p>\n<section>\n<section>In terms of foreign investment, the healthcare industry has been<strong>\u00a0steadily opening up to foreign participation<\/strong>\u00a0\u2013 both in terms of removal of items in the National Negative List, and the addition of items on the National Encouraged List.In 2020, under the category of \u201cmedical device industry\u201d, China added a laundry list of new items into the-<strong>\u00a0foreign investment encouraged catalogue<\/strong>, including manufacturing of AI medical aid equipment, high-end radiotherapy and surgical equipment, rehabilitation equipment, wearable intelligent health equipment, mobile and tele-medicine equipment, etc.<\/p>\n<\/section>\n<\/section>\n<section>\n<section>\n<section><\/section>\n<\/section>\n<\/section>\n<section>\n<section>\n<section><\/section>\n<\/section>\n<\/section>\n<section>\n<section><strong>Healthcare industries in China&#8217;s 2019 and 2020 Encouraged Lists<\/strong><img decoding=\"async\" class=\"alignnone size-full wp-image-5107\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3.jpg\" alt=\"\" width=\"900\" height=\"815\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3.jpg 900w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-300x272.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-768x695.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-13x12.jpg 13w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-80x72.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-620x561.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-460x417.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical3-365x331.jpg 365w\" sizes=\"(max-width: 900px) 100vw, 900px\" loading=\"lazy\" \/><\/p>\n<section>\n<section><strong>Market entry considerations<\/strong><\/section>\n<\/section>\n<section>\n<section><strong>T<\/strong><strong>he<\/strong><em><strong>\u00a0Regulations on Supervision and Administration of Medical Devices<\/strong><\/em>\u00a0(State Council Order No. 680) is the highest level of governing rules for the registration and record keeping of medical devices.<strong>Class I\u00a0<\/strong>is the lowest risk class, meaning that registration is comparatively easier, while\u00a0<strong>Class II and III<\/strong>\u00a0usually involves a longer and more rigorous process \u2013\u00a0<strong>typically requiring local testing and clinical trials prior<\/strong>\u00a0to its registration.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-5108\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4.jpg\" alt=\"\" width=\"900\" height=\"397\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4.jpg 900w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-300x132.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-768x339.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-16x7.jpg 16w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-80x35.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-620x273.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-460x203.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical4-365x161.jpg 365w\" sizes=\"(max-width: 900px) 100vw, 900px\" \/><\/p>\n<p>For each category, the company should\u00a0<strong>apply for<\/strong><strong>\u00a0production or distribution license<\/strong>.<\/p>\n<p>Firstly, production or distribution license application\u00a0requires a\u00a0<strong>registered address\u00a0<\/strong>and it should\u00a0<strong>be in accordance with\u00a0<\/strong><strong>real business operation address<\/strong>\u00a0according to the regulations.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-5109\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5.jpg\" alt=\"\" width=\"532\" height=\"749\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5.jpg 532w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5-213x300.jpg 213w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5-9x12.jpg 9w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5-57x80.jpg 57w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5-460x648.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5-365x514.jpg 365w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/Medical5-300x422.jpg 300w\" sizes=\"(max-width: 532px) 100vw, 532px\" \/><\/p>\n<section>\n<section>Besides, it has\u00a0<strong>strict standards\u00a0<\/strong>on professional staffs with allocated position, especially the quality management personnel play a very important role and it doesn&#8217;t allow one staff holds several positions or part-time position.Last but not least, it is required the\u00a0<strong>space area\u00a0<\/strong>with<strong>\u00a0the business office<\/strong>, at least\u00a0<strong>45 \u33a1<\/strong>\u00a0in Shanghai,etc.<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>","protected":false},"excerpt":{"rendered":"<p class=\"tx-excerpt\">China healthcare industry is currently ranked the\u00a0second largest\u00a0in the world behind the US. The market has\u00a0grown at a consistently rapid rate\u00a0in the past five years,\u00a0and in 2019, the market reached RMB 7.82 trillion, an increase...<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[29],"tags":[],"class_list":["post-5104","post","type-post","status-publish","format-standard","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>China\u2019s Medical Devices: Industry Key Market Entry Consideration - elitestage.cn<\/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.elitestage.cn\/de\/chinas-medical-devices-industry-key-market-entry-consideration\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"China\u2019s Medical Devices: Industry Key Market Entry Consideration - elitestage.cn\" \/>\n<meta property=\"og:description\" content=\"China healthcare industry is currently ranked the\u00a0second largest\u00a0in the world behind the US. 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