{"id":3586,"date":"2025-11-17T08:32:00","date_gmt":"2025-11-17T01:32:00","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=3586"},"modified":"2025-12-10T22:12:11","modified_gmt":"2025-12-10T15:12:11","slug":"chinese-medical-device-registration-complete-guide-for-global-manufacturers","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/chinese-medical-device-registration-complete-guide-for-global-manufacturers\/","title":{"rendered":"\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff1a\u5168\u7403\u5236\u9020\u5546\u5b8c\u6574\u6307\u5357"},"content":{"rendered":"<p>\u8fdb\u5165\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u5e02\u573a\u9700\u8981\u9075\u5b88\u7531\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5c40\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u76d1\u7ba1\u673a\u6784\u201d\uff09\u7ba1\u7406\u7684\u7ed3\u6784\u5316\u76d1\u7ba1\u6846\u67b6\u3002 <a href=\"https:\/\/www.easychinapprov.com\/NMPA\" target=\"_blank\" rel=\"noopener\">\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09<\/a>. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u662f\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u7684\u4e2d\u592e\u4e3b\u7ba1\u673a\u6784\uff0c\u8d1f\u8d23\u533b\u7597\u5668\u68b0\u7684\u4e0a\u5e02\u8bb8\u53ef\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1\u548c\u56fd\u5bb6\u6280\u672f\u6807\u51c6\u7684\u7ef4\u62a4\u3002\u5176\u6280\u672f\u8bc4\u4f30\u673a\u6784\u2014\u2014\u533b\u7597\u5668\u68b0\u8bc4\u5ba1\u4e2d\u5fc3\uff08CMDE\uff09\u2014\u2014\u5bf9\u6240\u6709\u7533\u8bf7\u8fdb\u884c\u79d1\u5b66\u8bc4\u5ba1\uff0c\u5305\u62ec\u9996\u6b21\u6ce8\u518c\u3001\u7eed\u5c55\u6ce8\u518c\u548c\u53d8\u66f4\u6ce8\u518c\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5148\u51b3\u6761\u4ef6\u548c\u5206\u7c7b<\/strong> \u4e2d\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c<\/h2>\n\n\n\n<p>\u5728\u4e2d\u56fd\uff0c\u5927\u591a\u6570\u4ea7\u54c1\u7684\u524d\u63d0\u6761\u4ef6\u662f\u62e5\u6709\u6709\u6548\u7684\u56fd\u5185\u5e02\u573a\u4ea7\u54c1\u8bc1\u4e66\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u901a\u5e38\u662f ISO 13485\u3002.<\/p>\n\n\n\n<p>\u5728\u7533\u8bf7\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4e4b\u524d\uff0c\u5236\u9020\u5546\u5fc5\u987b\u6839\u636e\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7684\u89c4\u5b9a\u786e\u8ba4\u5668\u68b0\u7684\u5206\u7c7b\u548c\u76f8\u5e94\u7684\u4ea7\u54c1\u4ee3\u7801\u3002.<\/p>\n\n\n\n<p>\u6839\u636e\u98ce\u9669\u7b49\u7ea7\u548c\u9884\u671f\u7528\u9014\uff0c\u533b\u7597\u5668\u68b0\u5206\u4e3a I \u7c7b\u3001II \u7c7b\u548c III \u7c7b\u3002\u786e\u5b9a\u6b63\u786e\u7684\u5206\u7c7b\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u5b83\u51b3\u5b9a\u4e86\u6280\u672f\u6587\u6863\u7684\u8be6\u5c3d\u7a0b\u5ea6\u548c\u4e34\u5e8a\u8981\u6c42\u3002.<\/p>\n\n\n\n<p>\u4f8b\u5982\uff0cI \u7c7b\u533b\u7597\u5668\u68b0\u901a\u5e38\u53ef\u4ee5\u901a\u8fc7\u5907\u6848\u7a0b\u5e8f\u8fdb\u884c\u5907\u6848\uff0c\u800c II \u7c7b\u548c III \u7c7b\u533b\u7597\u5668\u68b0\u5219\u9700\u8981\u7531\u4e2d\u56fd\u8ba4\u53ef\u7684\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u5168\u9762\u7684\u6280\u672f\u5ba1\u67e5\u548c\u4ea7\u54c1\u6d4b\u8bd5\u3002.\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6ce8\u518c\u751f\u547d\u5468\u671f\uff1a\u521d\u59cb\u6ce8\u518c\u3001\u53d8\u66f4\u6ce8\u518c\u548c\u7eed\u671f\u6ce8\u518c<\/strong><\/h2>\n\n\n\n<p>NMPA\u6ce8\u518c\u6d41\u7a0b\u9075\u5faa\u5b8c\u6574\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u7cfb\u7edf\u3002\u5b83\u5305\u62ec\u521d\u59cb\u6ce8\u518c\u3001\u53d8\u66f4\u6ce8\u518c\u548c\u6bcf\u4e94\u5e74\u4e00\u6b21\u7684\u7eed\u671f\uff08\u4e5f\u79f0\u4e3a\u5ef6\u671f\uff09\u3002.<\/p>\n\n\n\n<p>\u521d\u59cb\u6ce8\u518c\u5305\u62ec\u901a\u8fc7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7535\u5b50\u7cfb\u7edf\u63d0\u4ea4\u8d44\u6599\u3001\u5728\u4e2d\u56fd\u5408\u683c\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u578b\u5f0f\u8bd5\u9a8c\uff0c\u4ee5\u53ca\u7531\u4e2d\u56fd\u5236\u9020\u6280\u672f\u7814\u7a76\u59d4\u5458\u4f1a\uff08CMDE\uff09\u8fdb\u884c\u591a\u9636\u6bb5\u6280\u672f\u5ba1\u67e5\u3002\u5ba1\u6838\u901a\u8fc7\u540e\uff0c\u5c06\u9881\u53d1\u6ce8\u518c\u8bc1\u4e66\uff0c\u6709\u6548\u671f\u4e3a\u4e94\u5e74\u3002.<\/p>\n\n\n\n<p>\u5728\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\uff0c\u5bf9\u8bbe\u8ba1\u3001\u8d44\u6599\u6216\u5236\u9020\u5de5\u827a\u7684\u4efb\u4f55\u4fee\u6539\u90fd\u5fc5\u987b\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ee5\u786e\u5b9a\u5176\u662f\u5426\u7b26\u5408\u53d8\u66f4\u6ce8\u518c\u7684\u8981\u6c42\u3002\u6839\u636e\u7f8e\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7684\u89c4\u5b9a\u2026\u2026 <a href=\"https:\/\/www.easychinapprov.com\/change-registration\" target=\"_blank\" rel=\"noopener\">\u53d8\u66f4\u767b\u8bb0\u8981\u6c42<\/a>, \u67d0\u4e9b\u66f4\u65b0\u2014\u2014\u4f8b\u5982\u4ea7\u54c1\u540d\u79f0\u66f4\u65b0\u6216\u884c\u653f\u66f4\u6b63\u2014\u2014\u53ef\u4ee5\u4f5c\u4e3a\u884c\u653f\u53d8\u66f4\u63d0\u4ea4\u3002\u4f46\u662f\uff0c\u5173\u952e\u7684\u6280\u672f\u6216\u8bbe\u8ba1\u4fee\u6539\u5fc5\u987b\u7ecf\u8fc7\u6b63\u5f0f\u7684\u53d8\u66f4\u5ba1\u67e5\u3002.<\/p>\n\n\n\n<p>\u88ab\u89c6\u4e3a\u201c\u91cd\u5927\u201d\u7684\u53d8\u66f4\u5305\u62ec\u5bf9\u9884\u671f\u7528\u9014\u3001\u57fa\u672c\u8bbe\u8ba1\u539f\u5219\u3001\u539f\u6750\u6599\u3001\u706d\u83cc\u65b9\u6cd5\u7684\u66f4\u65b0\uff0c\u6216\u5f71\u54cd\u8bbe\u5907\u6027\u80fd\u6216\u5b89\u5168\u6027\u7684\u91cd\u5927\u8f6f\u4ef6\u4fee\u6539\u3002\u6b64\u7c7b\u53d8\u66f4\u5747\u9700\u91cd\u65b0\u5411\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (NMPA) \u63d0\u4ea4\u7533\u8bf7\u5e76\u63d0\u4f9b\u65b0\u7684\u578b\u5f0f\u8bd5\u9a8c\u7ed3\u679c\u3002.<\/p>\n\n\n\n<p>\u4e3a\u7ef4\u6301\u5e02\u573a\u51c6\u5165\u8bb8\u53ef\uff0c\u4ea7\u54c1\u5fc5\u987b\u6bcf\u4e94\u5e74\u8fdb\u884c\u4e00\u6b21\u7eed\u671f\u3002\u7eed\u671f\u7533\u8bf7\u5fc5\u987b\u8bc1\u660e\u4ea7\u54c1\u6301\u7eed\u7b26\u5408\u76f8\u5173\u6cd5\u89c4\uff0c\u6027\u80fd\u7a33\u5b9a\uff0c\u5e76\u5305\u542b\u6ce8\u518c\u671f\u95f4\u6807\u51c6\u6216\u6807\u7b7e\u7684\u4efb\u4f55\u66f4\u65b0\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5ba1\u6838\u65f6\u95f4\u548c\u6210\u672c<\/strong> \u533b\u7597\u5668\u68b0\u6ce8\u518c<\/h2>\n\n\n\n<p>\u5ba1\u6838\u65f6\u95f4\u548c\u5b98\u65b9\u8d39\u7528\u53d6\u51b3\u4e8e\u8bbe\u5907\u5206\u7c7b\u548c\u6d4b\u8bd5\u8981\u6c42\u3002\u5bf9\u4e8e\u5927\u591a\u6570\u4ea7\u54c1\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>II \u7c7b\u533b\u7597\u5668\u68b0<\/strong> \u4ece\u51c6\u5907\u7533\u8bf7\u6750\u6599\u5230\u9881\u53d1\u8bc1\u4e66\uff0c\u5927\u7ea6\u9700\u8981 16 \u81f3 24 \u4e2a\u6708\u3002.<\/li>\n\n\n\n<li><strong>III\u7c7b\u8bbe\u5907<\/strong>, \u9700\u8981\u8fdb\u884c\u66f4\u590d\u6742\u7684\u6d4b\u8bd5\u548c\u53ef\u80fd\u7684\u4e34\u5e8a\u8bc4\u4f30\uff0c\u901a\u5e38\u9700\u8981 24 \u81f3 36 \u4e2a\u6708\u3002.<\/li>\n<\/ul>\n\n\n\n<p>\u5b98\u65b9\u5ba1\u6838\u8d39\u3001\u6d4b\u8bd5\u8d39\u548c\u7ffb\u8bd1\u8d39\u5404\u4e0d\u76f8\u540c\u3002\u60a8\u53ef\u4ee5\u67e5\u770b\u8be6\u7ec6\u7684\u9884\u8ba1\u65f6\u95f4\u5b89\u6392\u3001\u5ba1\u6838\u9636\u6bb5\u548c\u653f\u5e9c\u6807\u51c6\u6536\u8d39\u660e\u7ec6\u3002 <a href=\"https:\/\/www.easychinapprov.com\/time-and-cost\" target=\"_blank\" rel=\"noopener\">\u8fd9\u91cc<\/a>.<\/p>\n\n\n\n<p>\u51c6\u5907\u5145\u5206\u7684\u6280\u672f\u6587\u6863\u548c\u53ca\u65e9\u4e0e\u6d4b\u8bd5\u5b9e\u9a8c\u5ba4\u63a5\u6d3d\u53ef\u4ee5\u663e\u8457\u7f29\u77ed\u5ba1\u67e5\u65f6\u95f4\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6280\u672f\u6587\u6863\u548c\u578b\u5f0f\u6d4b\u8bd5<\/strong><\/h2>\n\n\n\n<p>\u6280\u672f\u8d44\u6599\uff08TD\uff09\u662fNMPA\u8981\u6c42\u4e0b\u7684\u6838\u5fc3\u63d0\u4ea4\u6587\u4ef6\u5305\u3002\u5b83\u9075\u5faa\u6807\u51c6\u5316\u7684\u7ed3\u6784\uff0c\u5305\u62ec\u8bbe\u5907\u63cf\u8ff0\u3001\u9884\u671f\u7528\u9014\u3001\u8bbe\u8ba1\u9a8c\u8bc1\u548c\u786e\u8ba4\u3001\u751f\u4ea7\u4fe1\u606f\u3001\u8d28\u91cf\u7ba1\u7406\u6587\u4ef6\u3001\u98ce\u9669\u7ba1\u7406\u3001\u4e34\u5e8a\u8bc1\u636e\uff08\u6216\u8c41\u514d\u7406\u7531\uff09\u3001\u6807\u7b7e\u548c\u552e\u540e\u670d\u52a1\u8ba1\u5212\u3002.<\/p>\n\n\n\n<p>\u4e2d\u56fd\u8f66\u724c\u767b\u8bb0\u7684\u4e00\u4e2a\u72ec\u7279\u4e4b\u5904\u5728\u4e8e\u2026\u2026 <a href=\"https:\/\/www.easychinapprov.com\/type-testing\" target=\"_blank\" rel=\"noopener\">\u7c7b\u578b\u6d4b\u8bd5\u8fc7\u7a0b<\/a>. \u4e0e\u5176\u4ed6\u8bb8\u591a\u5e02\u573a\u4e0d\u540c\uff0c\u4e2d\u56fd\u901a\u5e38\u8981\u6c42\u6240\u6709II\u7c7b\u548cIII\u7c7b\u533b\u7597\u5668\u68b0\u90fd\u5fc5\u987b\u5728\u4e2d\u56fd\u5883\u5185\u7ecf\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u8ba4\u53ef\u7684\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u6d4b\u8bd5\u3002\u6d4b\u8bd5\u7ed3\u679c\u6784\u6210\u6280\u672f\u8bf4\u660e\u4e66\uff08TD\uff09\u7684\u4e00\u90e8\u5206\uff0c\u5e76\u4e14\u5fc5\u987b\u7b26\u5408\u5df2\u6279\u51c6\u7684\u4ea7\u54c1\u6280\u672f\u8981\u6c42\uff08PTR\uff09\u2014\u2014\u8fd9\u662f\u4e00\u4efd\u9488\u5bf9\u4e2d\u56fd\u5e02\u573a\u5236\u5b9a\u7684\u6027\u80fd\u6307\u6807\u548c\u5b89\u5168\u7279\u6027\u6982\u8981\u3002.<\/p>\n\n\n\n<p>\u6709\u5173\u5982\u4f55\u6784\u5efaTD\u3001\u6574\u5408PTR\u4ee5\u53ca\u51c6\u5907\u578b\u5f0f\u8bd5\u9a8c\u6837\u54c1\u7684\u6307\u5357\uff0c\u8bf7\u53c2\u89c1\u4ee5\u4e0b\u94fe\u63a5\uff1a <a href=\"https:\/\/www.easychinapprov.com\/chinese-TD\" target=\"_blank\" rel=\"noopener\">\u4e2d\u6587\u6280\u672f\u6587\u6863<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7279\u6b8a\u8def\u7ebf\uff1a\u5feb\u901f\u901a\u9053\u548c\u8bd5\u70b9\u533a\u57df<\/strong><\/h2>\n\n\n\n<p>\u4e3a\u4fc3\u8fdb\u521b\u65b0\u548c\u52a0\u5feb\u5e02\u573a\u51c6\u5165\uff0c\u4e2d\u56fd\u9488\u5bf9\u7279\u5b9a\u533b\u7597\u5668\u68b0\u8bbe\u7acb\u4e86\u8bd5\u70b9\u533a\u548c\u5feb\u901f\u901a\u9053\u3002\u8fd9\u4e9b\u901a\u9053\u65e8\u5728\u5e2e\u52a9\u521b\u65b0\u578b\u533b\u7597\u5668\u68b0\u3001\u6ee1\u8db3\u7d27\u6025\u4e34\u5e8a\u9700\u6c42\u6216\u4f7f\u5177\u6709\u5148\u8fdb\u76d1\u7ba1\u57fa\u7840\u8bbe\u65bd\u7684\u56fd\u9645\u4ea7\u54c1\u8fdb\u5165\u7279\u5b9a\u5730\u533a\u3002.<\/p>\n\n\n\n<p>\u7b26\u5408\u6761\u4ef6\u7684\u5236\u9020\u5546\u53ef\u4ee5\u901a\u8fc7\u7279\u6b8a\u7684\u5feb\u901f\u901a\u9053\u7533\u8bf7\u4f18\u5148\u8bc4\u4f30\u6216\u5e76\u884c\u6d4b\u8bd5\u548c\u5ba1\u67e5\uff0c\u4ece\u800c\u663e\u8457\u7f29\u77ed\u5ba1\u6279\u65f6\u95f4\u3002\u8be6\u60c5\u548c\u8d44\u683c\u6807\u51c6\u8be6\u89c1[\u6b64\u5904\u5e94\u63d2\u5165\u76f8\u5173\u6587\u6863\u6216\u6587\u4ef6]\u3002 <a href=\"https:\/\/www.easychinapprov.com\/fast-track-in-chinese-pilot-zone\" target=\"_blank\" rel=\"noopener\">\u4e2d\u56fd\u8bd5\u70b9\u533a\u5feb\u901f\u901a\u9053\u6307\u5357<\/a>.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-product-registration-indonesia wp-block-embed-product-registration-indonesia\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"FhJW1hsaR7\"><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/halal-certification-for-chinese-medical-device-companies-entering-indonesia-to-gain-trust-and-compliance\/\">\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u516c\u53f8\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u9700\u83b7\u5f97\u6e05\u771f\u8ba4\u8bc1\uff0c\u4ee5\u8d62\u5f97\u4fe1\u4efb\u548c\u5408\u89c4\u6027\u3002<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u516c\u53f8\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u9700\u83b7\u5f97\u6e05\u771f\u8ba4\u8bc1\uff0c\u4ee5\u8d62\u5f97\u4fe1\u4efb\u548c\u5408\u89c4\u6027\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/halal-certification-for-chinese-medical-device-companies-entering-indonesia-to-gain-trust-and-compliance\/embed\/#?secret=gBYmVTaHAL#?secret=FhJW1hsaR7\" data-secret=\"FhJW1hsaR7\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>\u65e8\u5728\u6269\u5927\u5168\u7403\u76d1\u7ba1\u8303\u56f4\u7684\u5408\u4f5c\u4f19\u4f34\u5173\u7cfb<\/strong><\/h4>\n\n\n\n<p><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u4ea7\u54c1\u6ce8\u518c<\/a> \u6b63\u5728\u4e0e\u2026\u2026\u5408\u4f5c <a href=\"https:\/\/www.easychinapprov.com\/\" target=\"_blank\" rel=\"noopener\">EasyChinApproV<\/a>, \u603b\u90e8\u4f4d\u4e8e\u5fb7\u56fd\uff0c\u65e8\u5728\u52a0\u5f3a\u6211\u4eec\u5168\u7403\u533b\u7597\u5668\u68b0\u6ce8\u518c\u76d1\u7ba1\u7f51\u7edc\u3002.<\/p>\n\n\n\n<p>\u901a\u8fc7\u6b64\u6b21\u5408\u4f5c\uff0cProduct Registration Indonesia \u5e26\u6765\u4e86\u5176\u5728\u5e94\u5bf9\u5370\u5c3c\u590d\u6742\u7684\u5ba1\u6279\u6d41\u7a0b\uff08\u6db5\u76d6 BPOM\u3001MoH \u548c\u6e05\u771f\u5408\u89c4\uff09\u65b9\u9762\u4e45\u7ecf\u8003\u9a8c\u7684\u4e13\u4e1a\u77e5\u8bc6\uff0c\u800c EasyChinApproV \u5219\u63d0\u4f9b\u4e86\u5bf9\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (NMPA) \u6ce8\u518c\u7cfb\u7edf\u7684\u6df1\u5165\u4e86\u89e3\u548c\u5b9e\u8df5\u7ecf\u9a8c\u3002.<\/p>\n\n\n\n<p>\u6211\u4eec\u643a\u624b\u5e2e\u52a9\u5236\u9020\u5546\u5728\u4e9a\u6d32\u548c\u6b27\u6d32\u5efa\u7acb\u65e0\u7f1d\u7684\u5408\u89c4\u6218\u7565\uff0c\u786e\u4fdd\u66f4\u5feb\u7684\u5e02\u573a\u51c6\u5165\u3001\u6587\u4ef6\u7684\u76f8\u4e92\u8ba4\u53ef\u4ee5\u53ca\u771f\u6b63\u7684\u5168\u7403\u6ce8\u518c\u8def\u7ebf\u56fe\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Entering the Chinese medical device market requires compliance with a structured regulatory framework managed by the National Medical Products Administration (NMPA). The NMPA is China\u2019s central authority for medical devices, responsible for market authorization, post-market supervision, and maintaining national technical standards. Its technical evaluation body, the Center for Medical Device Evaluation (CMDE), conducts scientific reviews [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":3590,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"country":[],"class_list":["post-3586","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/3586","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=3586"}],"version-history":[{"count":2,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/3586\/revisions"}],"predecessor-version":[{"id":3591,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/3586\/revisions\/3591"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/3590"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=3586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=3586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=3586"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=3586"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}