{"id":904,"date":"2024-02-05T14:20:45","date_gmt":"2024-02-05T06:20:45","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=904"},"modified":"2024-02-05T14:20:45","modified_gmt":"2024-02-05T06:20:45","slug":"why-is-nmpa-certification-so-important","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/why-is-nmpa-certification-so-important\/","title":{"rendered":"\u306a\u305cNMPA\u306e\u8a8d\u8a3c\u304c\u305d\u308c\u307b\u3069\u91cd\u8981\u306a\u306e\u3067\u3059\u304b\uff1f"},"content":{"rendered":"<p>NMPA\u3068\u306fNational Medical Products Administration\u306e\u7565\u3067\u3001\u4e2d\u56fd\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u5f53\u5c40\u3067\u3042\u308b\u3002\u4e2d\u56fd\u56fd\u5185\u3067\u533b\u7642\u6a5f\u5668\u3092\u8ca9\u58f2\u307e\u305f\u306f\u4f7f\u7528\u3059\u308b\u88fd\u9020\u4f01\u696d\u306f\u3001\u56fd\u5185\u751f\u7523\u3001\u8f38\u5165\u3092\u554f\u308f\u305a\u3001\u5bfe\u5fdc\u3059\u308b\u533b\u85ac\u54c1\u898f\u5236\u5f53\u5c40\u3078\u306e\u767b\u9332\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002<\/p>\n<p>NMPA\uff08\u56fd\u5bb6\u533b\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff09\u306f2013\u5e743\u670822\u65e5\u306b\u6b63\u5f0f\u306b\u8a2d\u7acb\u3055\u308c\u305f\u3002\u540c\u5c40\u306f\u56fd\u52d9\u9662\u306e\u76f4\u5c5e\u6a5f\u95a2\u3067\u3042\u308a\u3001\u533b\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u306b\u95a2\u3059\u308b\u56fd\u5bb6\u653f\u5e9c\u306e\u90e8\u5c40\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3066\u3044\u308b\u3002\u4e2d\u56fd\u306e\u533b\u85ac\u54c1\u76e3\u7763\u884c\u653f\u7d44\u7e54\u306e\u4e00\u90e8\u3068\u3057\u3066\u3001NMPA\u306f\u56fd\u5bb6\u533b\u85ac\u54c1\u898f\u5236\u30b7\u30b9\u30c6\u30e0\u306e\u4e2d\u3067\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter size-full wp-image-901\" title=\"NMPA\u3068\u306fNational Medical Products Administration\u306e\u7565\u3002\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-OYlhHhzksuk-unsplash.jpg\" alt=\"NMPA\u3068\u306fNational Medical Products Administration\u306e\u7565\u3002\" width=\"640\" height=\"417\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-OYlhHhzksuk-unsplash.jpg 640w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-OYlhHhzksuk-unsplash-300x195.jpg 300w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-OYlhHhzksuk-unsplash-18x12.jpg 18w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/p>\n<p>\u533b\u7642\u6a5f\u5668\u306e\u76e3\u7763\u5b98\u5e81\u3067\u3042\u308b\u56fd\u5bb6\u533b\u7642\u88fd\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u306f\u3001\"\u533b\u7642\u6a5f\u5668\u76e3\u7763\u7ba1\u7406\u6761\u4f8b \"\u3092\u901a\u3058\u3066\u95a2\u9023\u898f\u5236\u3092\u5b9f\u65bd\u3057\u3066\u3044\u308b\u3002NMPA\u304c\u767a\u884c\u3057\u305f\u300c\u533b\u7642\u6a5f\u5668\u88fd\u9020\u76e3\u7763\u7ba1\u7406\u5f01\u6cd5\u300d\u306b\u3088\u308b\u3068\u3001\u4e2d\u56fd\u56fd\u5185\u3067\u30af\u30e9\u30b9\u2161\u307e\u305f\u306f\u30af\u30e9\u30b9\u2162\u306e\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u3092\u55b6\u3080\u4f01\u696d\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u4f01\u696d\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u53d6\u5f97\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001NMPA\u304c\u516c\u5e03\u3057\u305f\u300c\u533b\u7642\u6a5f\u5668\u767b\u9332\u7ba1\u7406\u5f01\u6cd5\u300d\u306b\u57fa\u3065\u304d\u3001\u4e2d\u56fd\u56fd\u5185\u3067\u533b\u7642\u6a5f\u5668\u3092\u8ca9\u58f2\u307e\u305f\u306f\u4f7f\u7528\u3059\u308b\u88fd\u9020\u4f1a\u793e\uff08\u56fd\u5185\u751f\u7523\u304a\u3088\u3073\u8f38\u5165\u306e\u4e21\u65b9\uff09\u306f\u3001\u5bfe\u5fdc\u3059\u308b\u533b\u85ac\u54c1\u898f\u5236\u5f53\u5c40\u3078\u306e\u767b\u9332\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002<\/p>\n<p>\u8981\u3059\u308b\u306b\u3001NMPA\u306f\u3001\u88fd\u9020\u3001\u8ca9\u58f2\u3001\u4f7f\u7528\u3092\u542b\u3080\u533b\u7642\u6a5f\u5668\u7523\u696d\u306b\u304a\u3051\u308b\u69d8\u3005\u306a\u30d7\u30ed\u30bb\u30b9\u3092\u76e3\u7763\u3057\u3066\u3044\u308b\u3002NMPA\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u300cID\u30ab\u30fc\u30c9\u300d\u3092\u767a\u884c\u3059\u308b\u6a5f\u95a2\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2>NMPA\u8a8d\u8a3c - \u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u8b58\u5225<\/h2>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter size-full wp-image-900\" title=\"\u533b\u7642\u6a5f\u5668\u767b\u9332\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-GcrSgHDrniY-unsplash-1.jpg\" alt=\"\u533b\u7642\u6a5f\u5668\u767b\u9332\" width=\"640\" height=\"427\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-GcrSgHDrniY-unsplash-1.jpg 640w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-GcrSgHDrniY-unsplash-1-300x200.jpg 300w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/national-cancer-institute-GcrSgHDrniY-unsplash-1-18x12.jpg 18w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/p>\n<p>\u533b\u7642\u6a5f\u5668\u767b\u9332\u3068\u306f\u3001\u5e02\u5834\u3067\u306e\u8ca9\u58f2\u3084\u4f7f\u7528\u3092\u76ee\u7684\u3068\u3057\u305f\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u3092\u3001NMPA\u304c\u6cd5\u7684\u306a\u624b\u7d9a\u304d\u306b\u5f93\u3063\u3066\u4f53\u7cfb\u7684\u306b\u8a55\u4fa1\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002\u3053\u306e\u8a55\u4fa1\u306b\u3088\u3063\u3066\u3001\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u3084\u4f7f\u7528\u304c\u627f\u8a8d\u3055\u308c\u308b\u304b\u3069\u3046\u304b\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002<\/p>\n<p>NMPA \u8a8d\u8a3c\u3068\u3044\u3046\u300c\u8eab\u5206\u8a3c\u660e\u66f8\u300d\u306e\u53d6\u5f97\u306f\u3001\u500b\u4eba ID \u30ab\u30fc\u30c9\u306e\u53d6\u5f97\u307b\u3069\u5358\u7d14\u3067\u306f\u306a\u3044\u3002\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u305f\u3081\u306e\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306f\u975e\u5e38\u306b\u8907\u96d1\u3067\u3042\u308a\u3001\u767b\u9332\u7533\u8acb\u66f8\u306e\u88cf\u4ed8\u3051\u6587\u66f8\u306e\u8981\u4ef6\u306f\u304b\u306a\u308a\u53b3\u3057\u3044\u3002<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u767b\u9332\u8a3c\u660e\u66f8\u306e\u7533\u8acb\u306b\u5fc5\u8981\u306a\u4e00\u822c\u7684\u306a\u66f8\u985e\u3092\u898b\u3066\u307f\u307e\u3057\u3087\u3046\uff1a<\/p>\n<ol>\n<li>\u7533\u8acb\u8005\u306e\u30d3\u30b8\u30cd\u30b9\u8cc7\u683c\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3002<\/li>\n<li>\u77e5\u7684\u8ca1\u7523\u306e\u72b6\u6cc1\u3068\u305d\u308c\u3092\u88cf\u4ed8\u3051\u308b\u66f8\u985e<\/li>\n<li>\u751f\u308c\u3066\u304d\u305f\u7814\u7a76\u958b\u767a\u306e\u751f\u3044\u6708\u3068\u751f\u80b2\u671f\u3068\u751f\u80b2\u671f\u3002<\/li>\n<li>\u88fd\u54c1\u306e\u6280\u8853\u6587\u66f8\uff1a\n<ul>\n<li>\u9069\u7528\u7bc4\u56f2\u307e\u305f\u306f\u4f7f\u7528\u76ee\u7684\u3002<\/li>\n<li>\u52d5\u4f5c\u539f\u7406\u307e\u305f\u306f\u30e1\u30ab\u30cb\u30ba\u30e0\u3002<\/li>\n<li>\u4e3b\u306a\u6280\u8853\u4ed5\u69d8\u3068\u305d\u306e\u6c7a\u5b9a\u6839\u62e0\u3002<\/li>\n<li>\u4e3b\u539f\u6599\u3001\u4e3b\u8981\u90e8\u54c1\u3001\u88fd\u9020\u5de5\u7a0b\u3001\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u306e\u8981\u4ef6\u3002<\/li>\n<li>\u4e3b\u8981\u6280\u8853\u6307\u6a19\u306e\u691c\u67fb\u65b9\u6cd5\u3002<\/li>\n<\/ul>\n<\/li>\n<li>\u88fd\u54c1\u9769\u65b0\u306e\u8a3c\u660e\uff1a\n<ul>\n<li>\u4e3b\u8981\u5b66\u8853\u8a8c\u306b\u63b2\u8f09\u3055\u308c\u305f\u5b66\u8853\u8ad6\u6587\u3001\u30e2\u30ce\u30b0\u30e9\u30d5\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u3067\u3001\u88fd\u54c1\u306e\u81e8\u5e8a\u5fdc\u7528\u4fa1\u5024\u3092\u9069\u5207\u306b\u5b9f\u8a3c\u3057\u3066\u3044\u308b\u3082\u306e\u3002<\/li>\n<li>\u3059\u3067\u306b\u56fd\u5185\u5916\u3067\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u985e\u4f3c\u88fd\u54c1\u306e\u7528\u9014\u306e\u5206\u6790\u3068\u6bd4\u8f03\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3002<\/li>\n<li>\u88fd\u54c1\u306e\u9769\u65b0\u7684\u306a\u5185\u5bb9\u3068\u81e8\u5e8a\u5fdc\u7528\u306b\u304a\u3051\u308b\u91cd\u8981\u306a\u4fa1\u5024\u306b\u95a2\u3059\u308b\u6587\u66f8\u3002<\/li>\n<\/ul>\n<\/li>\n<li>\u88fd\u54c1\u30ea\u30b9\u30af\u5206\u6790\u30c7\u30fc\u30bf\u3002<\/li>\n<li>\u88fd\u54c1\u8aac\u660e\u66f8\uff08\u6848\uff09\u3002<\/li>\n<li>\u88fd\u54c1\u304c\u672c\u624b\u9806\u66f8\u306e\u7b2c2\u6761\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305d\u306e\u4ed6\u306e\u6587\u66f8\u3002<\/li>\n<li>\u63d0\u51fa\u66f8\u985e\u306e\u771f\u6b63\u6027\u306b\u95a2\u3059\u308b\u81ea\u5df1\u7533\u544a\u66f8\u3002<\/li>\n<\/ol>\n<p>\u533b\u7642\u6a5f\u5668\u767b\u9332\u8a3c\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u304b\u3064\u6709\u52b9\u306a\u5b58\u5728\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u56fd\u5bb6\u898f\u683c\u306e\u8a3c\u660e\u66f8\u3067\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001NMPA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u3001\u8a8d\u8a3c\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306f\u3001\u54c1\u8cea\u3092\u4fdd\u8a3c\u3057\u3001\u4fe1\u983c\u3067\u304d\u308b\u4f7f\u7528\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<p>\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u7dcf\u5c40\uff08NMPA\uff09\u306f\u3001\u9577\u5e74\u306b\u308f\u305f\u308a\u7d44\u7e54\u69cb\u6210\u3001\u8077\u8cac\u3001\u540d\u79f0\u3001\u7565\u79f0\u304c\u4f55\u5ea6\u304b\u5909\u66f4\u3055\u308c\u3066\u304d\u305f\u30021998\u5e74\u306eSDA\uff08\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff09\u304b\u30892003\u5e74\u306eSFDA\uff08\u56fd\u5bb6\u98df\u54c1\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff09\u3078\u30012013\u5e74\u306eCFDA\uff08\u4e2d\u56fd\u98df\u54c1\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff09\u304b\u30892018\u5e74\u306eNMPA\uff08\u56fd\u5bb6\u533b\u7642\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff09\u3078\u3068\u3002<\/p>\n<p>NMPA\u306b\u306f\u3001CDE\uff08\u533b\u85ac\u54c1\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\uff09\u3001CMDE\uff08\u533b\u7642\u6a5f\u5668\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\uff09\u3001CFDI\uff08\u533b\u85ac\u54c1\u67fb\u5bdf\u30bb\u30f3\u30bf\u30fc\uff09\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u4e0b\u90e8\u7d44\u7e54\u304c\u3042\u308b\u3002<\/p>\n<h2>NMPA3\u30af\u30e9\u30b9\u8a8d\u5b9a\u8a3c<\/h2>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter size-full wp-image-899\" title=\"NMPA3\u30af\u30e9\u30b9\u8a8d\u5b9a\u8a3c\" src=\"https:\/\/consulting-hmk.com\/wp-content\/uploads\/2024\/02\/cdc-XLhDvfz0sUM-unsplash.jpg\" alt=\"NMPA3\u30af\u30e9\u30b9\u8a8d\u5b9a\u8a3c\" width=\"640\" height=\"427\" srcset=\"https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/cdc-XLhDvfz0sUM-unsplash.jpg 640w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/cdc-XLhDvfz0sUM-unsplash-300x200.jpg 300w, https:\/\/www.consulting-hmk.com\/wp-content\/uploads\/2024\/02\/cdc-XLhDvfz0sUM-unsplash-18x12.jpg 18w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/p>\n<p>NMPA 3 ClassesCertificate\u3068\u306f\u3001\u56fd\u5bb6\u533b\u7642\u88fd\u54c1\u7ba1\u7406\u5c40\uff08NMPA\uff09\u304c\u767a\u884c\u3059\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u8a3c\u306e\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u30923\u3064\u306e\u30af\u30e9\u30b9\u306b\u5206\u985e\u3057\u3066\u3044\u308b\uff1a\u533b\u7642\u6a5f\u5668\u3092\u30af\u30e9\u30b9\u2160\u3001\u30af\u30e9\u30b9\u2161\u3001\u30af\u30e9\u30b9\u2162\u306b\u5206\u985e\u3057\u3066\u3044\u308b\u3002<\/p>\n<ol>\n<li>\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\uff1a\n<ul>\n<li>\u3053\u308c\u3089\u306f\u3001\u65e5\u5e38\u7684\u306a\u7ba1\u7406\u306b\u3088\u3063\u3066\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3067\u304d\u308b\u5f93\u6765\u306e\u533b\u7642\u6a5f\u5668\u3067\u3042\u308b\u3002<\/li>\n<li>\u4f8b\u3048\u3070\u3001\u666e\u901a\u306e\u533b\u7642\u7528\u30de\u30b9\u30af\u3001\u8840\u5727\u8a08\u3001\u4f53\u6e29\u8a08\u306a\u3069\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n<\/li>\n<li>\u30af\u30e9\u30b9 II 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stands for the National Medical Products Administration, which is the regulatory authority for medical devices in China. Any manufacturing company selling or using medical devices within China, whether domestically produced or imported, is required to register with the corresponding drug regulatory authority. NMPA, or the National Medical Products Administration, was officially established on March 22, 2013. It operates directly under the State Council and serves as the national government&#8217;s department for drug supervision and management. As part of China&#8217;s administrative organization for drug oversight, NMPA plays a crucial role within the national drug regulatory system. As the regulatory authority for medical devices, the National Medical Products Administration (NMPA) enforces [&hellip;]<\/p>","protected":false},"author":1,"featured_media":902,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[70],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/904"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/comments?post=904"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/904\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/902"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=904"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/categories?post=904"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/tags?post=904"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}