{"id":609,"date":"2026-10-31T14:29:07","date_gmt":"2026-10-31T01:29:07","guid":{"rendered":"https:\/\/www.bbm.co.nz\/zh\/insights\/nmpa-registration-guide\/"},"modified":"2026-10-31T14:49:47","modified_gmt":"2026-10-31T01:49:47","slug":"nmpa-registration-guide","status":"publish","type":"page","link":"https:\/\/www.bbm.co.nz\/zh\/insights\/nmpa-registration-guide\/","title":{"rendered":"\u5883\u5916\u533b\u7597\u5668\u68b0\u8fdb\u5165\u4e2d\u56fd\uff1aNMPA \u6ce8\u518c\u6307\u5357"},"content":{"rendered":"
\n
\n

\u4e13\u4e1a\u89c2\u70b9 \u00b7 NMPA \u6ce8\u518c<\/p>\n

\u5883\u5916\u533b\u7597\u5668\u68b0\u8fdb\u5165\u4e2d\u56fd\uff1aNMPA \u6ce8\u518c\u6307\u5357<\/h1>\n

\u6ce8\u518c\u8def\u5f84\u3001NMPA \u4e0e\u7f8e\u56fd FDA \u548c\u6fb3\u5927\u5229\u4e9a TGA \u7684\u6bd4\u8f83\uff0c\u4ee5\u53ca\u5883\u5916\u4f01\u4e1a\u6700\u5e38\u95ee\u7684\u51e0\u4e2a\u95ee\u9898\u3002<\/p>\n<\/section>\n

\n

\u84dd\u8272\u52a8\u529b\uff08BBM\uff09\u00b7 2026 \u5e74 10 \u6708 31 \u65e5<\/p>\n

\n

NMPA \u6ce8\u518c\u8def\u5f84\u6982\u89c8<\/h2>\n
    \n
  1. \u6ce8\u518c\u7b56\u7565\u3002<\/strong>\u786e\u8ba4\u6ce8\u518c\u76ee\u6807\u548c\u4ea7\u54c1\u5206\u7c7b\uff0c\u9009\u62e9\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u3002<\/li>\n
  2. \u4ea7\u54c1\u6280\u672f\u8981\u6c42\u3002<\/strong>\u8d77\u8349\u4ea7\u54c1\u6280\u672f\u8981\u6c42\uff0c\u89c4\u5b9a\u4ea7\u54c1\u7684\u6027\u80fd\u6307\u6807\u3001\u68c0\u9a8c\u65b9\u6cd5\u548c\u5408\u683c\u6807\u51c6\uff0c\u662f\u540e\u7eed\u68c0\u9a8c\u548c\u5ba1\u8bc4\u7684\u57fa\u7840\u6587\u4ef6\u3002<\/li>\n
  3. \u6ce8\u518c\u68c0\u9a8c\u3002<\/strong>\u6309\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u8fdb\u884c\u5b89\u5168\u548c\u6027\u80fd\u68c0\u9a8c\uff0c\u53ef\u59d4\u6258\u6709\u8d44\u8d28\u7684\u68c0\u9a8c\u673a\u6784\uff0c\u4e5f\u53ef\u7531\u6ce8\u518c\u4eba\u81ea\u68c0\u3002<\/li>\n
  4. \u4e34\u5e8a\u8bc4\u4ef7\u3002<\/strong>\u53ef\u901a\u8fc7\u514d\u4e8e\u4e34\u5e8a\u8bc4\u4ef7\u76ee\u5f55\u3001\u540c\u54c1\u79cd\u6bd4\u5bf9\u6216\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5b8c\u6210\u3002\u8fd9\u4e00\u6b65\u901a\u5e38\u4e0e\u6ce8\u518c\u68c0\u9a8c\u540c\u65f6\u8fdb\u884c\u3002<\/li>\n
  5. \u6ce8\u518c\u8d44\u6599\u51c6\u5907\u3002<\/strong>\u6280\u672f\u6587\u4ef6\u3001\u8bf4\u660e\u4e66\u548c\u6807\u7b7e\uff1b\u82f1\u6587\u539f\u4ef6\u7ecf\u516c\u8bc1\uff0c\u5e76\u9644\u4e2d\u6587\u8bd1\u672c\u3002<\/li>\n
  6. \u9012\u4ea4\u4e0e\u5ba1\u8bc4\u3002<\/strong>\u5668\u5ba1\u4e2d\u5fc3\u6280\u672f\u5ba1\u8bc4\u3001\u53d1\u8865\u56de\u590d\u3001\u884c\u653f\u5ba1\u6279\uff0c\u53d6\u5f97\u6ce8\u518c\u8bc1\u3002<\/li>\n<\/ol>\n

    \u7b2c 3 \u6b65\u548c\u7b2c 4 \u6b65\u901a\u5e38\u540c\u65f6\u8fdb\u884c\uff0c\u4ee5\u7f29\u77ed\u6574\u4f53\u5468\u671f\u3002\u7b2c\u4e8c\u7c7b\u3001\u7b2c\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u4ece\u542f\u52a8\u5230\u53d6\u8bc1\uff0c\u4e00\u822c\u9700\u8981 1.5 \u81f3 3 \u5e74\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u4ea7\u54c1\u5206\u7c7b\u3001\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u548c\u53d1\u8865\u8f6e\u6b21\u3002<\/p>\n<\/section>\n

    \n

    \u7f8e\u56fd FDA\u3001\u6fb3\u5927\u5229\u4e9a TGA \u4e0e\u4e2d\u56fd NMPA \u6bd4\u8f83<\/h2>\n
    \n\n\n\n\n\n\n\n\n\n\n\n
    <\/th>\n\u7f8e\u56fd FDA<\/th>\n\u6fb3\u5927\u5229\u4e9a TGA<\/th>\n\u4e2d\u56fd NMPA<\/th>\n<\/tr>\n<\/thead>\n
    \u8d28\u91cf\u4f53\u7cfb<\/td>\nQMSR\uff0821 CFR 820\uff0c\u5df2\u4e0e ISO 13485 \u5bf9\u9f50\uff09<\/td>\n\u901a\u8fc7\u7b26\u5408\u6027\u8bc4\u4f30\u91c7\u7528 ISO 13485<\/td>\n\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/td>\n<\/tr>\n
    \u5b89\u5168\u548c\u6027\u80fd\u8981\u6c42<\/td>\n\u8ba4\u53ef\u6807\u51c6\u4e0e\u7279\u6b8a\u63a7\u5236<\/td>\n\u57fa\u672c\u539f\u5219\uff08Essential Principles\uff09<\/td>\n\u533b\u7597\u5668\u68b0\u5b89\u5168\u548c\u6027\u80fd\u57fa\u672c\u539f\u5219\uff1b\u4ea7\u54c1\u6280\u672f\u8981\u6c42<\/td>\n<\/tr>\n
    \u4ea7\u54c1\u5206\u7c7b<\/td>\nI \/ II \/ III \u7c7b<\/td>\nI \/ IIa \/ IIb \/ III \u7c7b\u53ca\u6709\u6e90\u690d\u5165\u5668\u68b0<\/td>\n\u7b2c\u4e00 \/ \u4e8c \/ \u4e09\u7c7b<\/td>\n<\/tr>\n
    \u4e3b\u8981\u4e0a\u5e02\u9014\u5f84<\/td>\n510(k)\u3001De Novo\u3001PMA<\/td>\n\u7ecf\u7b26\u5408\u6027\u8bc4\u4f30\u5217\u5165 ARTG<\/td>\nNMPA \u6ce8\u518c\uff08\u5668\u5ba1\u4e2d\u5fc3\u5ba1\u8bc4\uff09<\/td>\n<\/tr>\n
    \u4e34\u5e8a\u8bc1\u636e<\/td>\n510(k) \u5b9e\u8d28\u7b49\u540c\u6216 PMA \u4e34\u5e8a\u6570\u636e<\/td>\n\u4e34\u5e8a\u8bc1\u636e\u6307\u5357<\/td>\n\u514d\u4e8e\u4e34\u5e8a\u8bc4\u4ef7\u76ee\u5f55\u3001\u540c\u54c1\u79cd\u6bd4\u5bf9\u6216\u4e34\u5e8a\u8bd5\u9a8c\uff08\u53ef\u63a5\u53d7\u5883\u5916\u6570\u636e\uff09<\/td>\n<\/tr>\n
    \u9012\u4ea4\u8bed\u8a00<\/td>\n\u82f1\u6587<\/td>\n\u82f1\u6587<\/td>\n\u7b80\u4f53\u4e2d\u6587\uff08\u5f3a\u5236\uff09<\/td>\n<\/tr>\n
    \u672c\u5730\u4ee3\u8868<\/td>\n\u7f8e\u56fd\u4ee3\u7406\u4eba<\/td>\n\u6fb3\u5927\u5229\u4e9a\u7533\u529e\u65b9\uff08Sponsor\uff09<\/td>\n\u5883\u5185\u4ee3\u7406\u4eba<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u4e09\u5957\u4f53\u7cfb\u5728\u7a0b\u5e8f\u548c\u8bed\u8a00\u4e0a\u5404\u4e0d\u76f8\u540c\uff0c\u4f46\u8bc1\u636e\u903b\u8f91\u662f\u4e00\u81f4\u7684\uff1a\u53d7\u76ca\u98ce\u9669\u8bc4\u4f30\u3001\u5b89\u5168\u548c\u6027\u80fd\u57fa\u672c\u539f\u5219\uff0c\u4ee5\u53ca\u4e34\u5e8a\u8bc1\u636e\u7684\u5c42\u7ea7\u3002\u4e3a\u4e00\u4e2a\u76d1\u7ba1\u673a\u6784\u51c6\u5907\u5145\u5206\u7684\u8d44\u6599\uff0c\u662f\u5411\u5176\u4ed6\u673a\u6784\u7533\u62a5\u7684\u826f\u597d\u57fa\u7840\uff0c\u524d\u63d0\u662f\u6309\u5404\u81ea\u7684\u8981\u6c42\u91cd\u65b0\u7ec4\u7ec7\u3002<\/p>\n<\/section>\n

    \n

    \u5e38\u89c1\u95ee\u9898<\/h2>\n
    \n
    \n

    \u80fd\u5426\u76f4\u63a5\u628a FDA \u6216 TGA \u7684\u7533\u62a5\u8d44\u6599\u7ffb\u8bd1\u6210\u4e2d\u6587\u9012\u4ea4\uff1f<\/h3>\n

    \u4e0d\u80fd\u3002NMPA \u8981\u6c42\u6309\u5176\u6280\u672f\u8981\u6c42\u7ec4\u7ec7\u8bc1\u636e\u3002\u53ea\u505a\u7ffb\u8bd1\uff0c\u5f80\u5f80\u4f1a\u6536\u5230\u53d1\u8865\u901a\u77e5\uff0c\u5ef6\u8bef\u6570\u6708\u3002<\/p>\n<\/div>\n

    \n

    \u5df2\u7ecf\u53d6\u5f97 FDA \u6216 TGA \u6279\u51c6\uff0c\u80fd\u5426\u52a0\u5feb NMPA \u5ba1\u8bc4\uff1f<\/h3>\n

    \u6709\u52a9\u4e8e\u63d0\u9ad8\u53ef\u4fe1\u5ea6\uff0c\u4f46\u4e0d\u80fd\u514d\u9664 NMPA \u7684\u6ce8\u518c\u68c0\u9a8c\u6216\u4e34\u5e8a\u8bc4\u4ef7\u3002\u5e94\u6309\u5b8c\u6574\u6ce8\u518c\u6765\u89c4\u5212\uff0c\u4e0d\u5e94\u671f\u5f85\u5feb\u901f\u901a\u9053\u3002<\/p>\n<\/div>\n

    \n

    \u662f\u5426\u4e00\u5b9a\u8981\u5728\u4e2d\u56fd\u505a\u4e34\u5e8a\u8bd5\u9a8c\uff1f<\/h3>\n

    \u5f80\u5f80\u4e0d\u9700\u8981\u3002\u5f88\u591a\u4ea7\u54c1\u53ef\u4ee5\u901a\u8fc7\u514d\u4e8e\u4e34\u5e8a\u8bc4\u4ef7\u76ee\u5f55\u6216\u540c\u54c1\u79cd\u6bd4\u5bf9\u5b8c\u6210\u4e34\u5e8a\u8bc4\u4ef7\uff1b\u7b26\u5408\u8981\u6c42\u7684\u5883\u5916\u4e34\u5e8a\u6570\u636e\u4e5f\u53ef\u4ee5\u63a5\u53d7\u3002\u5c3d\u65e9\u786e\u5b9a\u8def\u5f84\uff0c\u540e\u9762\u80fd\u8282\u7701\u4e00\u5e74\u65f6\u95f4\u3002<\/p>\n<\/div>\n

    \n

    \u4ec0\u4e48\u65f6\u5019\u5f15\u5165\u6cd5\u89c4\u987e\u95ee\u6700\u5408\u9002\uff1f<\/h3>\n

    \u6700\u597d\u5728\u8bbe\u8ba1\u51bb\u7ed3\u4e4b\u524d\u3002\u68c0\u9a8c\u5f00\u59cb\u4e4b\u524d\u505a\u7684\u4fee\u6539\uff0c\u6210\u672c\u6700\u4f4e\u3002<\/p>\n<\/div>\n<\/div>\n<\/section>\n

    \n

    \u84dd\u8272\u52a8\u529b\uff08BBM\uff09\u80fd\u505a\u4ec0\u4e48<\/h2>\n

    \u6211\u4eec\u4e3a NMPA \u6ce8\u518c\u51c6\u5907\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599\u3001\u8bc1\u636e\u5dee\u8ddd\u5206\u6790\u548c\u53d1\u8865\u56de\u590d\uff0c\u5e76\u5c06\u6ce8\u518c\u8d44\u6599\u7ffb\u8bd1\u6210\u4e2d\u6587\u3002NMPA \u6cd5\u89c4\u54a8\u8be2\u4e0e\u5408\u4f5c\u4f19\u4f34 Best-Road (Beijing) \u5171\u540c\u63d0\u4f9b\u3002\u8be6\u89c1\u6cd5\u89c4\u54a8\u8be2<\/a>\u548c\u7ffb\u8bd1\u670d\u52a1<\/a>\u3002<\/p>\n<\/section>\n<\/div>\n

    \n

    \u6b63\u5728\u89c4\u5212 NMPA \u6ce8\u518c\uff1f<\/h2>\n

    \u544a\u8bc9\u6211\u4eec\u4ea7\u54c1\u60c5\u51b5\u548c\u65f6\u95f4\u8981\u6c42\uff0c\u6211\u4eec\u4f1a\u63d0\u51fa\u5de5\u4f5c\u8303\u56f4\u548c\u62a5\u4ef7\u3002<\/p>\n

    \u8054\u7cfb\u54a8\u8be2\u56e2\u961f<\/a><\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    \u4e13\u4e1a\u89c2\u70b9 \u00b7 NMPA \u6ce8\u518c \u5883\u5916\u533b\u7597\u5668\u68b0\u8fdb\u5165\u4e2d\u56fd\uff1aNMPA \u6ce8\u518c\u6307\u5357 \u6ce8\u518c\u8def\u5f84\u3001NMPA \u4e0e\u7f8e\u56fd FDA \u548c […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":608,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-609","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/609","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/comments?post=609"}],"version-history":[{"count":2,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/609\/revisions"}],"predecessor-version":[{"id":639,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/609\/revisions\/639"}],"up":[{"embeddable":true,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/608"}],"wp:attachment":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/media?parent=609"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}