{"id":92,"date":"2026-09-28T20:56:53","date_gmt":"2026-09-28T12:56:53","guid":{"rendered":"http:\/\/medifun.com.tw\/"},"modified":"2026-10-22T16:32:09","modified_gmt":"2026-10-22T08:32:09","slug":"how-to-evaluate-taiwan-lancing-device-oem","status":"publish","type":"post","link":"https:\/\/medifun.com.tw\/en\/how-to-evaluate-taiwan-lancing-device-oem\/","title":{"rendered":"\u5982\u4f55\u8a55\u9078\u53f0\u7063\u63a1\u8840\u7b46\/\u5b89\u5168\u63a1\u8840\u91dd\u4ee3\u5de5\u5925\u4f34"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u627e\u53f0\u7063\u63a1\u8840\u7b46\u4ee3\u5de5\u5ee0\u7684\u54c1\u724c\u5546\u3001\u901a\u8def\u5546\uff0c\u5e38\u5e38\u5361\u5728\u540c\u4e00\u500b\u554f\u984c\uff1a\u600e\u9ebc\u78ba\u8a8d\u5c0d\u65b9\u771f\u7684\u6709\u80fd\u529b\u91cf\u7522\u3001\u800c\u4e14\u8b49\u66f8\u662f\u771f\u7684\uff1f\u9019\u7bc7\u6587\u7ae0\u6574\u7406\u8a55\u9078\u91ab\u6750\u4ee3\u5de5\u5925\u4f34\u6642\uff0c\u5be6\u969b\u8a72\u6838\u5c0d\u7684\u5e7e\u500b\u95dc\u9375\u6307\u6a19\uff0c\u5e6b\u52a9\u4f60\u5728\u8a55\u4f30\u968e\u6bb5\u5c31\u80fd\u554f\u5c0d\u554f\u984c\u3002<\/p>\n\n\n\n<figure class=\"wp-block-pullquote\"><blockquote><p><em>\u8a55\u9078\u53f0\u7063\u63a1\u8840\u7b46\/\u5b89\u5168\u63a1\u8840\u91dd\u4ee3\u5de5\u5925\u4f34\u6642\uff0c\u5efa\u8b70\u81f3\u5c11\u6838\u5c0d\u56db\u4ef6\u4e8b\uff1a\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u8b49\u66f8\uff08\u5982ISO 13485\uff09\u662f\u5426\u53ef\u5411\u767c\u8b49\u6a5f\u69cb\u67e5\u8b49\u3001\u7522\u54c1\u662f\u5426\u5df2\u53d6\u5f97\u76ee\u6a19\u5e02\u5834\u7684\u6cd5\u898f\u8a31\u53ef\uff08\u5982\u7f8e\u570bFDA 510(k)\u3001\u53f0\u7063TFDA\uff09\u3001\u662f\u5426\u6301\u6709\u771f\u6b63\u6838\u51c6\u7684\u5c08\u5229\uff08\u800c\u975e\u53ea\u662f\u7533\u8acb\u4e2d\uff09\uff0c\u4ee5\u53ca\u5c0d\u65b9\u662f\u88fd\u9020\u5546\u9084\u662f\u8cbf\u6613\u5546\u8f49\u624b\u3002<\/em><\/p><\/blockquote><\/figure>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u600e\u9ebc\u78ba\u8a8dISO 13485\u8b49\u66f8\u662f\u771f\u7684\uff1f<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 13485\u662f\u91ab\u7642\u5668\u6750\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u7684\u570b\u969b\u6a19\u6e96\uff0c\u6b63\u5f0f\u8b49\u66f8\u4e0a\u6703\u6a19\u660e\u767c\u8b49\u6a5f\u69cb\u3001\u8b49\u66f8\u7de8\u865f\u8207\u6709\u6548\u671f\u9650\u3002\u5982\u4f55\u8a55\u9078ISO 13485\u91ab\u6750\u4ee3\u5de5\u5ee0\uff0c\u7b2c\u4e00\u6b65\u5c31\u662f\u76f4\u63a5\u5411\u8b49\u66f8\u4e0a\u5217\u51fa\u7684\u767c\u8b49\u6a5f\u69cb\u67e5\u8b49\u8b49\u66f8\u72c0\u614b\uff0c\u800c\u4e0d\u662f\u53ea\u770b\u5c0d\u65b9\u63d0\u4f9b\u7684PDF\u6a94\u6848\u2014\u2014\u904e\u671f\u6216\u7121\u6cd5\u67e5\u8b49\u7684\u8b49\u66f8\uff0c\u662f\u8a55\u9078\u904e\u7a0b\u4e2d\u7b2c\u4e00\u500b\u8a72\u7559\u610f\u7684\u8b66\u8a0a\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u4ee3\u5de5\u5ee0\u6709\u6c92\u6709\u5be6\u969b\u53d6\u5f97FDA 510(k)\u6216TFDA\u8a31\u53ef\uff1f<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">FDA 510(k)\u8ddf\u53f0\u7063TFDA\u91ab\u7642\u5668\u6750\u8a31\u53ef\uff0c\u90fd\u662f\u7522\u54c1\u6b63\u5f0f\u4e0a\u5e02\u524d\u7684\u6cd5\u898f\u95dc\u5361\uff0c\u6838\u51c6\u6587\u4ef6\u4e0a\u6703\u6709\u660e\u78ba\u7684\u6848\u865f\uff0c\u53ef\u4ee5\u5728\u5b98\u65b9\u8cc7\u6599\u5eab\u67e5\u8a62\u5c0d\u61c9\u7684\u7522\u54c1\u540d\u7a31\u8207\u6838\u51c6\u65e5\u671f\u3002\u8209\u4f8b\u4f86\u8aaa\uff0cMedifun\u65d7\u4e0bDuoSafe Lancing Device\uff08LD-E1\uff09\u6301\u6709FDA 510(k) K231797\uff0cDuoSafe Safety Lancet\uff08MSL1\uff09\u6301\u6709K241750\uff0c\u9019\u985e\u6848\u865f\u5c31\u662f\u53ef\u4ee5\u76f4\u63a5\u67e5\u6838\u7684\u5177\u9ad4\u4f9d\u64da\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u5c08\u5229\u662f\u300c\u5df2\u6838\u51c6\u300d\u9084\u662f\u300c\u7533\u8acb\u4e2d\u300d\uff0c\u600e\u9ebc\u5206\u8fa8\uff1f<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">\u5c08\u5229\u7533\u8acb\u4e2d\u53ea\u4ee3\u8868\u905e\u4ea4\u4e86\u7533\u8acb\uff0c\u4e0d\u4ee3\u8868\u6700\u7d42\u6703\u6838\u51c6\uff0c\u5169\u8005\u5728\u8a55\u4f30\u4ee3\u5de5\u5925\u4f34\u7684\u6280\u8853\u542b\u91cf\u6642\u610f\u7fa9\u5b8c\u5168\u4e0d\u540c\u3002\u5efa\u8b70\u76f4\u63a5\u8acb\u5c0d\u65b9\u63d0\u4f9b\u5c08\u5229\u8b49\u66f8\uff08\u800c\u975e\u7533\u8acb\u6536\u64da\uff09\uff0c\u4e26\u78ba\u8a8d\u5c08\u5229\u865f\u78bc\u3001\u6838\u51c6\u570b\u5bb6\u8207\u5c08\u5229\u985e\u578b\uff0c\u624d\u80fd\u5224\u65b7\u9019\u9805\u6280\u8853\u662f\u5426\u771f\u7684\u53d7\u5230\u4fdd\u8b77\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u88fd\u9020\u5546\u8ddf\u8cbf\u6613\u5546\uff0c\u4ee3\u5de5\u54c1\u8cea\u6709\u4ec0\u9ebc\u5dee\u5225\uff1f<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u9020\u5546\u81ea\u5df1\u64c1\u6709\u6a5f\u69cb\u8a2d\u8a08\u80fd\u529b\u8207\u7522\u7dda\uff0c\u63a1\u8840\u7b46OEM\u4ee3\u5de5\u7684\u5ba2\u88fd\u5316\u5f48\u6027\u8ddf\u54c1\u7ba1\u638c\u63e1\u5ea6\u901a\u5e38\u6bd4\u8f03\u9ad8\uff1b\u8cbf\u6613\u5546\u5247\u662f\u5411\u5176\u4ed6\u5de5\u5ee0\u63a1\u8cfc\u5f8c\u8f49\u552e\uff0c\u4e2d\u9593\u591a\u4e00\u5c64\u6e9d\u901a\u6210\u672c\uff0c\u5ba2\u88fd\u5316\u9700\u6c42\u4e5f\u6bd4\u8f03\u96e3\u76f4\u63a5\u843d\u5730\u3002\u8a55\u4f30\u968e\u6bb5\u53ef\u4ee5\u76f4\u63a5\u8a62\u554f\u5c0d\u65b9\u7684\u5be6\u969b\u7522\u7dda\u8207\u6a5f\u69cb\u8a2d\u8a08\u5718\u968a\u898f\u6a21\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u5b89\u5168\u63a1\u8840\u91ddODM\u4ee3\u5de5\uff0c\u8ddf\u4e00\u822cOEM\u6709\u4ec0\u9ebc\u4e0d\u540c\uff1f<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">OEM\u901a\u5e38\u662f\u4f9d\u7167\u5ba2\u6236\u65e2\u6709\u8a2d\u8a08\u898f\u683c\u4ee3\u5de5\u751f\u7522\uff0cODM\u5247\u662f\u4ee3\u5de5\u5ee0\u672c\u8eab\u5c31\u5177\u5099\u7522\u54c1\u8a2d\u8a08\u80fd\u529b\uff0c\u53ef\u4ee5\u5f9e\u6a5f\u69cb\u8a2d\u8a08\u968e\u6bb5\u5c31\u53c3\u8207\u958b\u767c\u3002\u5b89\u5168\u63a1\u8840\u91ddODM\u4ee3\u5de5\u7684\u50f9\u503c\u5728\u65bc\uff0c\u4ee3\u5de5\u5ee0\u80fd\u4f9d\u7167\u5ba2\u6236\u7684\u7522\u54c1\u5b9a\u4f4d\uff08\u4f8b\u5982\u75bc\u75db\u611f\u3001\u5b89\u5168\u9396\u5b9a\u6a5f\u5236\uff09\u63d0\u51fa\u5de5\u7a0b\u89e3\u6cd5\uff0c\u800c\u4e0d\u53ea\u662f\u7167\u5716\u4ee3\u5de5\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u91ab\u6750\u4ee3\u5de5FDA\u8a8d\u8b49\u67e5\u6838\uff0c\u6709\u54ea\u4e9b\u5177\u9ad4\u6b65\u9a5f\uff1f<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">\u91ab\u6750\u4ee3\u5de5FDA\u8a8d\u8b49\u67e5\u6838\u5efa\u8b70\u5206\u4e09\u6b65\uff1a\u7b2c\u4e00\uff0c\u5411\u5c0d\u65b9\u7d22\u53d6510(k)\u6848\u865f\uff1b\u7b2c\u4e8c\uff0c\u7528\u8a72\u6848\u865f\u5728FDA\u5b98\u65b9\u8cc7\u6599\u5eab\u6bd4\u5c0d\u7522\u54c1\u540d\u7a31\u3001\u7533\u8acb\u516c\u53f8\u540d\u7a31\u662f\u5426\u4e00\u81f4\uff1b\u7b2c\u4e09\uff0c\u78ba\u8a8d\u6838\u51c6\u7bc4\u570d\u662f\u5426\u6db5\u84cb\u4f60\u5be6\u969b\u8981\u63a1\u8cfc\u7684\u7522\u54c1\u578b\u865f\uff0c\u907f\u514d\u8aa4\u628a\u540c\u7cfb\u5217\u5176\u4ed6\u7522\u54c1\u7684\u8a31\u53ef\u7576\u6210\u4f50\u8b49\u3002<\/p>\n\n\n\n<figure class=\"wp-block-pullquote\"><blockquote><p><em>Medifun\uff08\u777f\u5eb7\u751f\u91ab\uff09\u662f\u4f4d\u65bc\u53f0\u4e2d\u7684\u7cbe\u5bc6\u6a5f\u69cb\u8a2d\u8a08\u4ee3\u5de5\u5ee0\uff0c\u65d7\u4e0bDuoSafe\u7cfb\u5217\u540c\u6642\u6301\u6709ISO 13485\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u3001FDA 510(k)\u8a31\u53ef\uff08LD-E1 K231797\u3001MSL1 K241750\uff09\u8207\u53f0\u7063TFDA\u91ab\u7642\u5668\u6750\u8a31\u53ef\uff0c\u5c08\u5229\u6280\u8853\u6db5\u84cb\u53f0\u7063\u3001\u7f8e\u570b\u3001\u4e2d\u570b\u3001\u97d3\u570b\u3002<\/em><\/p><\/blockquote><\/figure>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>\u5e38\u898b\u554f\u984c FAQ<\/strong><\/h2>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u600e\u9ebc\u78ba\u8a8d\u53f0\u7063\u91ab\u6750\u4ee3\u5de5\u5ee0\u7684ISO 13485\u8b49\u66f8\u662f\u771f\u7684\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u76f4\u63a5\u5411\u8b49\u66f8\u4e0a\u5217\u51fa\u7684\u767c\u8b49\u6a5f\u69cb\u67e5\u8b49\u8b49\u66f8\u7de8\u865f\u8207\u6709\u6548\u72c0\u614b\uff0c\u800c\u4e0d\u662f\u53ea\u770b\u5c0d\u65b9\u63d0\u4f9b\u7684PDF\u6a94\u6848\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA 510(k)<\/strong><strong>\u8ddfFDA approved\u6709\u4ec0\u9ebc\u4e0d\u540c\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">510(k)\u662f\u300c\u5df2\u7372\u51c6\u4e0a\u5e02\u300d\u7684\u901a\u77e5\u6587\u4ef6\uff0c\u7528\u8a5e\u4e0a\u61c9\u5beb\u300cFDA 510(k) cleared\u300d\uff0c\u800c\u4e0d\u662f\u300cFDA approved\u300d\uff0c\u5169\u8005\u5728\u6cd5\u898f\u610f\u7fa9\u4e0a\u4e0d\u5b8c\u5168\u76f8\u540c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u91ab\u6750\u4ee3\u5de5\u7684\u5c08\u5229\u300c\u7533\u8acb\u4e2d\u300d\u4ee3\u8868\u4ec0\u9ebc\uff0c\u53ef\u4ee5\u7576\u4f5c\u8ce3\u9ede\u55ce\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7533\u8acb\u4e2d\u53ea\u4ee3\u8868\u905e\u4ef6\uff0c\u5c1a\u672a\u78ba\u5b9a\u662f\u5426\u6838\u51c6\uff0c\u8a55\u4f30\u4ee3\u5de5\u5925\u4f34\u6642\u5efa\u8b70\u660e\u78ba\u5340\u5206\u300c\u5df2\u6838\u51c6\u5c08\u5229\u300d\u8207\u300c\u7533\u8acb\u4e2d\u300d\uff0c\u907f\u514d\u8aa4\u5224\u6280\u8853\u542b\u91cf\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u600e\u9ebc\u5206\u8fa8\u4ee3\u5de5\u5925\u4f34\u662f\u88fd\u9020\u5546\u9084\u662f\u8cbf\u6613\u5546\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u53ef\u4ee5\u76f4\u63a5\u8a62\u554f\u5c0d\u65b9\u7684\u7522\u7dda\u4f4d\u7f6e\u3001\u6a5f\u69cb\u8a2d\u8a08\u5718\u968a\u898f\u6a21\uff0c\u88fd\u9020\u5546\u901a\u5e38\u80fd\u5177\u9ad4\u8aaa\u660e\u91cf\u7522\u6d41\u7a0b\uff0c\u8cbf\u6613\u5546\u5247\u8f03\u96e3\u63d0\u4f9b\u9019\u985e\u7d30\u7bc0\u3002<\/p>\n\n\n\n<p 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