{"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\/zh\/chinas-medical-devices-industry-key-market-entry-consideration\/","title":{"rendered":"\u9999\u6e2f\u516c\u53f8\u65e5\u5e38\u7ecf\u8425\u7ef4\u62a4\u6307\u5357"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-5105\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/06\/0.gif\" alt=\"\" width=\"1080\" height=\"866\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/><\/p>\n<p><\/br><div style=\"text-align: center\">\u8d8a\u6765\u8d8a\u591a\u7684\u516c\u53f8\u9009\u62e9<\/br>\n\u5728\u9999\u6e2f\u6ce8\u518c\u516c\u53f8<\/br>\n\u4ee5\u4eab\u53d7\u9999\u6e2f\u6781\u5177<\/br>\n\u4f18\u52bf\u7684\u7a0e\u7387\u53ca\u8425\u5546\u73af\u5883\n<\/br><\/br>\n\u6ce8\u518c\u516c\u53f8\u540e<\/br>\n\u4ecd\u7136\u9700\u8981\u5408\u89c4\u7ecf\u8425<\/br>\n\u624d\u80fd\u89e3\u9664\u540e\u987e\u4e4b\u5fe7\n<\/br><\/br>\n\u4eca\u5929\u5c31\u4e3a\u5927\u5bb6\u603b\u7ed3\u51e0\u4e2a<\/br>\n\u5bb9\u6613\u5ffd\u89c6\u7684\u5c0f\u7ec6\u8282<\/br><\/div><strong>\u00a0second largest\u00a0<\/strong>in the world behind the US.<\/p>\n<p><h4><b>\u516c\u53f8\u4e1a\u52a1\u6027\u8d28\u662f\u5fc5\u586b\u9879<\/b><\/h4>\u00a0<strong>grown at a consistently rapid rate<\/strong><strong>\u00a0in the past five years,<\/strong>\u00a0<\/br>\u4e1a\u52a1\u6027\u8d28\uff0c\u7b80\u5355\u6765\u8bf4\uff0c\u5176\u5b9e\u7c7b\u4f3c\u4e8e\u6211\u4eec\u5185\u5730\u516c\u53f8\u7684\u7ecf\u8425\u8303\u56f4\u3002\u00a0<strong>10 percent<\/strong>\u00a0<\/br><\/br>\u5bf9\u4e8e\u5df2\u7ecf\u6709\u8fd0\u8425\u7684\u9999\u6e2f\u516c\u53f8\uff0c\u9999\u6e2f\u6ce8\u518c\u5904\u8981\u6c42\u5728\u5546\u4e1a\u767b\u8bb0\u8bc1\u4e0a\u6dfb\u52a0\u4e1a\u52a1\u6027\u8d28\uff1a\u5373\u5982\u767b\u8bb0\u8bc1\u4e0a\u663e\u793a\u300cCORP\u300d\uff0c\u5219\u9700\u8981\u5728\u4e1a\u52a1\u5b9e\u9645\u5f00\u59cb\u65e5\u671f\u8d77\u8ba11\u4e2a\u6708\u5185\uff0c\u6dfb\u52a0\u4e1a\u52a1\u6027\u8d28\u4fe1\u606f\u3002\u5982\u67e5\u6838\u672a\u6dfb\u52a0\u8005\uff0c\u9999\u6e2f\u516c\u53f8\u5c06\u4f1a\u53d7\u5230\u5904\u7f5a\u3002<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-5106\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB.jpg\" alt=\"\" width=\"900\" height=\"762\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB.jpg 580w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB-300x133.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB-16x7.jpg 16w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB-80x35.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB-460x204.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/RMB-365x162.jpg 365w\" sizes=\"(max-width: 900px) 100vw, 900px\" loading=\"lazy\" \/><\/p>\n<p><\/br><\/br><h4><b>\u9999\u6e2f\u516c\u53f8\u9700\u8981\u6302\u7535\u5b50\u6c34\u724c\n<\/b><\/h4><\/p>\n<p>\u9999\u6e2f\u6ce8\u518c\u5904\u8981\u6c42\u9999\u6e2f\u516c\u53f8\u9700\u8981\u5728\u5176\u6ce8\u518c\u529e\u4e8b\u5904\u548c\u4e1a\u52a1\u573a\u6240\u5c55\u793a\u5176\u540d\u79f0\uff0c\u56e0\u6b64\uff0c\u6302\u7535\u5b50\u6c34\u724c\u662f\u6bcf\u95f4\u7b26\u5408\u300a\u516c\u53f8\u6761\u4f8b\u300b\u8981\u6c42\u7684\u9999\u6e2f\u516c\u53f8\u6240\u5fc5\u987b\u505a\u7684\u3002<\/br><\/br>\u00a0<strong>considerable opportunities\u00a0<\/strong><img src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/BANG.jpg\" alt=\"\" loading=\"lazy\" \/>\u00a0<strong>laid out multiple initiatives<\/strong>\u00a0<\/br><\/br>\u9999\u6e2f\u516c\u53f8\u7684\u7535\u5b50\u6c34\u724c\u5373\u7528\u60ac\u6302\u5728\u663e\u773c\u4f4d\u7f6e\u7684\u7535\u5b50\u5668\u6750\u6eda\u52a8\u64ad\u653e\u9999\u6e2f\u516c\u53f8\u540d\u79f0\u3002\u5f53\u7136\uff0c\u4e5f\u6709\u4ee5\u4e0b\u4e09\u79cd\u4f8b\u5916\u60c5\u51b5\uff0c\u662f\u4e0d\u9700\u8981\u6302\u6c34\u724c\u7684\uff1a<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><div style=\"margin-left: -1px;margin-top: -10px\">3. \u5ba2\u6237\u5982\u4e0d\u662f\u59d4\u6258\u79d8\u4e66\u516c\u53f8\uff0c\u800c\u662f\u81ea\u5df1\u79df\/\u8d2d\u4e70\u9999\u6e2f\u7684\u623f\u5b50\u4f5c\u4e3a\u5176\u9999\u6e2f\u516c\u53f8\u7684\u6ce8\u518c\u5730\u5740\uff0c\u8fd9\u4e2a\u6ce8\u518c\u5730\u5740\u6240\u6ce8\u518c\u7684\u516c\u53f8\u5c11\u4e8e6\u95f4\u9999\u6e2f\u516c\u53f8\u3002<\/div><\/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><\/br><h4><b>\u91cd\u8981\u63a7\u5236\u4eba\u767b\u8bb0<\/b><\/h4><\/strong><img decoding=\"async\" class=\"alignnone size-full wp-image-5107\" src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG.jpg\" alt=\"\" width=\"900\" height=\"815\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG.jpg 900w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-300x2.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-768x4.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-16x1.jpg 16w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-750x5.jpg 750w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-80x1.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-620x3.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-460x3.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-365x2.jpg 365w\" sizes=\"(max-width: 900px) 100vw, 900px\" loading=\"lazy\" \/><\/p>\n<section>\n<section><strong><div style=\"margin-top: -30px\">\u9664\u4e0a\u5e02\u516c\u53f8\u5916\uff0c\u6240\u6709\u5728\u6e2f\u6210\u7acb\u7684\u516c\u53f8\u90fd\u9700\u8981\u5bf9\u91cd\u8981\u63a7\u5236\u4eba\u8fdb\u884c\u767b\u8bb0\u5728\u518c\uff0c\u5e76\u5907\u5b58\u5728\u6ce8\u518c\u529e\u4e8b\u5904\u6216\u9999\u6e2f\u6307\u5b9a\u5730\u5740\uff0c\u4ee5\u4f9b\u653f\u5e9c\u6267\u6cd5\u4eba\u5458\u968f\u65f6\u8fdb\u884c\u67e5\u9605\uff08\u5373\u5907\u5b58SCR\uff09\u3002<\/div><\/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><div style=\"margin-top: -40px\"><img src=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/12\/ZHONGYAO.jpg\" alt=\"\" loading=\"lazy\"><\/div>\u00a0<strong>Class II and III<\/strong>\u00a0\u4e25\u683c\u5907\u5b58\u91cd\u8981\u63a7\u5236\u4eba\u767b\u8bb0\u518c\uff0c\u5bf9\u4e8e\u9999\u6e2f\u516c\u53f8\u6765\u8bf4\u662f\u5341\u5206\u91cd\u8981\u7684\u3002\u5c24\u5176\u662f\u76ee\u524d\u9999\u6e2f\u4e0e\u5185\u5730\u5df2\u5f00\u59cb\u6b63\u5f0f\u4ea4\u6362\u91d1\u878d\u8d26\u6237\u4fe1\u606f\uff0c\u9999\u6e2f\u653f\u5e9c\u5bf9\u4e8eSCR\u7684\u5b9e\u65bd\u5c06\u66f4\u52a0\u4e25\u683c\u7ba1\u63a7\u3002\u82e5\u53d1\u73b0\u672a\u4e25\u683c\u5c65\u884c\u8be5\u9879\u653f\u7b56\u7684\u516c\u53f8\uff0c\u6240\u6709\u8d23\u4efb\u4eba\u4e0d\u4ec5\u8981\u7f34\u7eb3\u9ad8\u989d\u7f5a\u6b3e\uff0c\u800c\u4e14\u8fd8\u53ef\u80fd\u9762\u4e34\u76d1\u7981\u7684\u5904\u7f5a\u3002\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\/08\/KONG.jpg\" alt=\"\" width=\"900\" height=\"397\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG.jpg 900w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-300x2.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-768x4.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-16x1.jpg 16w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-750x5.jpg 750w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-80x1.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-620x3.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-460x3.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-365x2.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\/08\/KONG.jpg\" alt=\"\" width=\"532\" height=\"749\" srcset=\"https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG.jpg 900w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-300x2.jpg 300w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-768x4.jpg 768w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-16x1.jpg 16w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-750x5.jpg 750w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-80x1.jpg 80w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-620x3.jpg 620w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-460x3.jpg 460w, https:\/\/www.elitestage.cn\/wp-content\/uploads\/2021\/08\/KONG-365x2.jpg 365w\" sizes=\"(max-width: 532px) 100vw, 532px\" \/><\/p>\n<section>\n<section><div style=\"margin-top: -130px\"><h4><b>\u6309\u8981\u6c42\u5e74\u5ba1<\/b><\/h4><\/div>\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>\u4ea7\u751f\u9ad8\u989d\u7f5a\u6b3e\u540e\uff0c\u53ef\u80fd\u4f1a\u6536\u5230\u9999\u6e2f\u6cd5\u9662\u4f20\u7968\uff0c\u6cd5\u9662\u4f1a\u6839\u636e\u300a\u516c\u53f8\u6cd5\u300b\u76f8\u5173\u6761\u4f8b\u8d77\u8bc9\u516c\u53f8\u8463\u4e8b\u548c\u80a1\u4e1c\uff0c\u8fd9\u6837\u4e00\u6765\u8463\u4e8b\u548c\u80a1\u4e1c\u4fe1\u8a89\u53d7\u635f\uff0c\u5bf9\u4e8e\u4ee5\u540e\u529e\u7406\u9999\u6e2f\u4e1a\u52a1\u6216\u8005\u51fa\u5883\u90fd\u4f1a\u6709\u4e25\u91cd\u5f71\u54cd\u3002<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 v27.7 - 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\/zh\/chinas-medical-devices-industry-key-market-entry-consideration\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\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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