{"id":192225,"date":"2020-11-15T18:19:53","date_gmt":"2020-11-16T01:19:53","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/summaries-of-safety\/"},"modified":"2023-01-07T06:17:05","modified_gmt":"2023-01-07T13:17:05","slug":"sscp%e7%bf%bb%e8%af%91","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/sscp%e7%bf%bb%e8%af%91\/","title":{"rendered":"SSCP\u7ffb\u8bd1"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|0px|0px”][et_pb_fullwidth_header text_orientation=”center” button_one_text=”\u7acb\u5373\u8054\u7cfb\u6211\u4eec” button_one_url=”https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%81%94%e7%b3%bb\/” background_overlay_color=”rgba(0,0,0,0.26)” content_max_width=”80%” content_max_width_tablet=”” content_max_width_phone=”” content_max_width_last_edited=”on|desktop” module_class=”hide-h1″ _builder_version=”4.5.3″ title_font=”||||||||” content_font_size=”22px” content_line_height=”1.6em” background_color=”rgba(255,255,255,0)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/11\/medical-devices-translation.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”80px||90px|” custom_padding_tablet=”” custom_padding_phone=”50px||50px|” custom_padding_last_edited=”on|desktop” content_font_size_tablet=”” content_font_size_phone=”17px” content_font_size_last_edited=”on|desktop” button_one_text_size__hover_enabled=”off” button_one_text_size__hover=”null” button_two_text_size__hover_enabled=”off” button_two_text_size__hover=”null” button_one_text_color__hover_enabled=”off” button_one_text_color__hover=”null” button_two_text_color__hover_enabled=”off” button_two_text_color__hover=”null” button_one_border_width__hover_enabled=”off” button_one_border_width__hover=”null” button_two_border_width__hover_enabled=”off” button_two_border_width__hover=”null” button_one_border_color__hover_enabled=”off” button_one_border_color__hover=”null” button_two_border_color__hover_enabled=”off” button_two_border_color__hover=”null” button_one_border_radius__hover_enabled=”off” button_one_border_radius__hover=”null” button_two_border_radius__hover_enabled=”off” button_two_border_radius__hover=”null” button_one_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover=”null” button_two_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover=”null” button_one_bg_color__hover_enabled=”off” button_one_bg_color__hover=”null” button_two_bg_color__hover_enabled=”off” button_two_bg_color__hover=”null”]<\/p>\n

\u5b89\u5168\u548c\u4e34\u5e8a\u8868\u73b0\u6458\u8981\uff1a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u76f8\u5173\u7684SSCP\u7ffb\u8bd1<\/h2>\n

CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u4e3a\u5728\u6b27\u76df\u53d1\u5c55\u7684\u533b\u7597\u5668\u68b0\u516c\u53f8\u63d0\u4f9b\u51c6\u786e\u548c\u9ad8\u6548\u7684\u5b89\u5168\u548c\u4e34\u5e8a\u8868\u73b0\u6458\u8981\uff08SSCP\uff09\u7ffb\u8bd1\u3002<\/p>\n

[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”23px|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ custom_padding=”0|0px|0|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][divienhancer_breadcrumb _builder_version=”3.20.2″][\/divienhancer_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ parallax=”on” custom_margin=”||0px” custom_padding=”||”][et_pb_row _builder_version=”3.25″ custom_padding=”0px||0px” border_color_bottom=”#cccccc”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px”]<\/p>\n

EUDAMED\uff08\u6b27\u6d32\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff09\u516c\u5e03\u4e86SSCPs\uff0c\u5b83\u662f\u7531\u6b27\u76dfMDR\u5efa\u7acb\u7684\u6570\u636e\u5e93\u548c\u7535\u5b50\u7cfb\u7edf\u7684\u96c6\u5408\uff0c\u7528\u4e8e\u6536\u96c6\u6570\u636e\uff0c\u5e76\u5c06\u4f5c\u4e3a\u4e00\u4e2a\u4fe1\u606f\u7cfb\u7edf\uff0c\u7528\u4e8e\u4ea4\u6362\u6cd5\u5f8b\u4fe1\u606f\u3002\u6b27\u76df\u662f\u4e00\u4e2a\u91cd\u8981\u7684\uff0c\u4e14\u76d1\u7ba1\u6807\u51c6\u53ca\u5176\u590d\u6742\u7684\u533b\u7597\u5668\u68b0\u5e02\u573a\uff0cSSCP\u7684\u7ffb\u8bd1\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u516c\u53f8\u9ad8\u6548\u901a\u8fc7\u76d1\u7ba1\u5ba1\u6279\uff0c\u5e76\u901a\u8fc724\u79cd\u6b27\u76df\u8bed\u8a00\u63a5\u89e6\u5230\u4e0d\u540c\u7c7b\u578b\u7684\u60a3\u8005\u3002\u5b89\u5168\u6027\u548c\u4e34\u5e8a\u8868\u73b0\u6458\u8981\u662f\u6b27\u76df\u59d4\u5458\u4f1a\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u8981\u6c42\u4e4b\u4e00\uff0c\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u6761\u4f8b\u300b\uff08MDR\uff0c\u7b2c32\u6761\uff09\uff0c\u9002\u7528\u4e8e\u690d\u5165\u6027\u8bbe\u5907\u548c\u7b2c\u4e09\u7c7b\u8bbe\u5907\uff08\u5b9a\u5236\u6216\u7814\u7a76\u6027\u8bbe\u5907\u9664\u5916\uff09\uff0c\u6839\u636e\uff08IVDR\uff0c\u7b2c29\u6761\uff09\uff0c\u9002\u7528\u4e8eC\u7c7b\u548cD\u7c7b\u8bbe\u5907\uff08\u6027\u80fd\u7814\u7a76\u7528\u8bbe\u5907\u9664\u5916\uff09\u3002<\/p>\n

SSCP\u7ffb\u8bd1\u8fc7\u7a0b\u7684\u6838\u5fc3\u76ee\u6807\u662f\u63d0\u9ad8\u900f\u660e\u5ea6\uff0c\u4e3a\u7528\u6237\u63d0\u4f9b\u5305\u62ec\u8bbe\u5907\u5b89\u5168\u6027\u3001\u4e34\u5e8a\u6570\u636e\u548c\u4e34\u5e8a\u8868\u73b0\u5728\u5185\u7684\u6700\u65b0\u6458\u8981\u7ffb\u8bd1\u3002SSCP\u7ffb\u8bd1\u6839\u636e\u8bbe\u5907\u7684\u6280\u672f\u6587\u4ef6\u8fdb\u884c\u5b9a\u5236\uff0c\u5305\u62ec\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff08CER\uff09<\/u><\/a>\u3001\u4e0a\u5e02\u540e\u76d1\u6d4b\u548c\u4e0a\u5e02\u540e\u4e34\u5e8a\u968f\u8bbf\uff08PMCF\uff09<\/u><\/a>\uff0c\u5e76\u5728PMCF\u548cPSUR\u66f4\u65b0\u65f6\u8fdb\u884c\u540c\u6b65\u66f4\u65b0\u3002SSCP\u7ffb\u8bd1\u4e5f\u5fc5\u987b\u7531\u6307\u5b9a\u673a\u6784\uff08NB\uff09\u9a8c\u8bc1\uff0c\u7136\u540e\u4e0a\u4f20\u5230EUDAMED\uff0c\u6bcf\u5e74\u5b9a\u671f\u66f4\u65b0\u3002SSCPs\u4e0d\u4ec5\u6709\u52a9\u4e8e\u4e0e\u516c\u4f17\u5206\u4eab\u4fe1\u606f\uff0c\u63d0\u4f9b\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u533b\u7597\u8bbe\u5907\u62a4\u7406\uff0c\u8fd8\u80fd\u8ba9\u5236\u9020\u5546\u66f4\u6df1\u5165\u5730\u4e86\u89e3\u7ade\u4e89\u683c\u5c40\uff0c\u5e76\u5e2e\u52a9\u4ed6\u4eec\u987a\u5229\u901a\u8fc7\u76d1\u7ba1\u5ba1\u6279\u3002<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#f9f9f9″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/11\/academic-translation01.jpg” parallax=”on” custom_margin=”||0px” custom_padding=”0px||0px” locked=”off”][et_pb_row column_structure=”2_3,1_3″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”||60px” border_color_bottom=”#cccccc”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_color=”#000000″]<\/p>\n

SSCP\u8986\u76d6\u4e86\u4e24\u4e2a\u677f\u5757\uff1a\u533b\u62a4\u4eba\u5458\u548c\u60a3\u8005\u3002\u66f4\u5177\u4f53\u6765\u770b\uff0c\u5176\u5305\u542b\u4e5d\u4e2a\u90e8\u5206\uff0c\u6db5\u76d6\u4e86\u4e0d\u540c\u7684\u65b9\u9762\uff0c\u5305\u62ec\u9884\u671f\u7528\u9014\u3001\u9002\u5e94\u75c7\u3001\u7981\u5fcc\u75c7\u3001\u8bbe\u5907\u63cf\u8ff0\u3001\u66ff\u4ee3\u54c1\u3001\u57f9\u8bad\u3001\u4e34\u5e8a\u8bc4\u4f30\u548cPMCF\u6458\u8981\u3001\u4fee\u8ba2\u5386\u53f2\u3001\u53c2\u8003\u6807\u51c6\u7b49\u3002<\/p>\n

\u7f16\u5199\u8fd9\u4e9b\u6587\u4ef6\u9700\u8981\u5f88\u5f3a\u7684\u6280\u672f\u548c\u79d1\u5b66\u5199\u4f5c\u80fd\u529b\uff0c\u4ee5\u53ca\u4ee5\u5ba2\u89c2\u7684\u65b9\u5f0f\u5411\u4e0d\u540c\u7684\u53d7\u4f17\u5c55\u793a\u6570\u636e\u7684\u80fd\u529b\u3002\u91cd\u8981\u7684\u662f\uff0c\u533b\u7597\u5668\u68b0\u534f\u8c03\u5c0f\u7ec4\uff08MDCG\uff09\u6307\u5357\u8981\u6c42\u5c06SSCP\u7684\u7ffb\u8bd1\u7eb3\u5165\u5236\u9020\u5546\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u3002\u4e00\u65e6NB\u9a8c\u8bc1\u4e86SSCP\uff0c\u5236\u9020\u5546\u9700\u8981\u5c06SSCP\u7ffb\u8bd1\u6210\u6240\u6709\u76f8\u5173\u7684\u6b27\u76df\u8bed\u8a00\u3002\u5982\u679c\u4e3bSSCP\u662f\u4ee5\u6b27\u6d32\u8bed\u8a00\u9a8c\u8bc1\u7684\uff0c\u5236\u9020\u5546\u9700\u8981\u63d0\u4f9b\u82f1\u6587\u7ffb\u8bd1\uff0c\u7136\u540e\u9700\u8981\u5728\u4e3bSSCP\u4e0a\u4f20\u540e\u768490\u5929\u5185\u63d0\u4f9b\u7ed9NB\u3002\u4e4b\u540e\uff0cNB\u5fc5\u987b\u572815\u5929\u5185\u5c06\u5176\u4e0a\u4f20\u81f3EUDAMED\u3002\u7ffb\u8bd1\u540e\u7684\u6458\u8981\u5e94\u5728\u4ea7\u54c1\u5206\u53d1\u9500\u552e\u524d\u5728EUDAMED\u4e0a\u4ee5\u5f53\u5730\u8bed\u8a00\u63d0\u4f9b\u3002NB\u65e0\u9700\u8fdb\u884c\u9a8c\u8bc1\uff0c\u4f46\u9700\u8981\u5728\u6536\u5230\u5236\u9020\u5546\u7684\u901a\u77e5\u540e15\u5929\u5185\u4e0a\u4f20\u5230EUDAMED\u3002<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#f9f9f9″ parallax=”on” custom_margin=”||0px” custom_padding=”0px||0px” locked=”off”][et_pb_row column_structure=”2_5,3_5″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”||60px” border_width_bottom=”1px” border_color_bottom=”#ccc”][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/10\/pharmaceuticals.png” alt=”Summaries of safety” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”77%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_color=”#000000″]<\/p>\n

CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u5982\u4f55\u9ad8\u6548\u7f16\u5199\u548c\u7ffb\u8bd1SSCP\uff1a<\/h3>\n