Current China NMPA Clinical Pathways for Medical Device Registration

Version
Download 703
File Size 214KB
File Count 1
Create Date November 18, 2020
Last Updated January 6, 2022

Current China NMPA Clinical Pathways for Medical Device Registration

Attached Files

File	Action
1605760026wpdm_Current_China_NMPA_clinical_pathways_for_medical_device_registration_by_Grace.pdf	Download

Guideline & Standard, NMPA (CFDA) Regulations, What's New, White Papers

#wpadminbar #wp-admin-bar-p404_free_top_button .ab-icon:before{content:"";color:red;top:2px;}img.wp-smiley,img.emoji{display:inline !important;border:none !important;box-shadow:none !important;height:1em !important;width:1em !important;margin:0 .07em !important;vertical-align:-.1em !important;background:none !important;padding:0 !important;}.wp-block-button__link{color:#fff;background-color:#32373c;border-radius:9999px;box-shadow:none;text-decoration:none;padding:calc(.667em + 2px) calc(1.333em + 2px);font-size:1.125em;}.wp-block-file__button{background:#32373c;color:#fff;text-decoration:none;}body{--wp--preset--color--black:#000;--wp--preset--color--cyan-bluish-gray:#abb8c3;--wp--preset--color--white:#fff;--wp--preset--color--pale-pink:#f78da7;--wp--preset--color--vivid-red:#cf2e2e;--wp--preset--color--luminous-vivid-orange:#ff6900;--wp--preset--color--luminous-vivid-amber:#fcb900;--wp--preset--color--light-green-cyan:#7bdcb5;--wp--preset--color--vivid-green-cyan:#00d084;--wp--preset--color--pale-cyan-blue:#8ed1fc;--wp--preset--color--vivid-cyan-blue:#0693e3;--wp--preset--color--vivid-purple:#9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple:linear-gradient(135deg,rgba(6,147,227,1) 0%,#9b51e0 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan:linear-gradient(135deg,#7adcb4 0%,#00d082 100%);--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange:linear-gradient(135deg,rgba(252,185,0,1) 0%,rgba(255,105,0,1) 100%);--wp--preset--gradient--luminous-vivid-orange-to-vivid-red:linear-gradient(135deg,rgba(255,105,0,1) 0%,#cf2e2e 100%);--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray:linear-gradient(135deg,#eee 0%,#a9b8c3 100%);--wp--preset--gradient--cool-to-warm-spectrum:linear-gradient(135deg,#4aeadc 0%,#9778d1 20%,#cf2aba 40%,#ee2c82 60%,#fb6962 80%,#fef84c 100%);--wp--preset--gradient--blush-light-purple:linear-gradient(135deg,#ffceec 0%,#9896f0 100%);--wp--preset--gradient--blush-bordeaux:linear-gradient(135deg,#fecda5 0%,#fe2d2d 50%,#6b003e 100%);--wp--preset--gradient--luminous-dusk:linear-gradient(135deg,#ffcb70 0%,#c751c0 50%,#4158d0 100%);--wp--preset--gradient--pale-ocean:linear-gradient(135deg,#fff5cb 0%,#b6e3d4 50%,#33a7b5 100%);--wp--preset--gradient--electric-grass:linear-gradient(135deg,#caf880 0%,#71ce7e 100%);--wp--preset--gradient--midnight:linear-gradient(135deg,#020381 0%,#2874fc 100%);--wp--preset--font-size--small:13px;--wp--preset--font-size--medium:20px;--wp--preset--font-size--large:36px;--wp--preset--font-size--x-large:42px;--wp--preset--spacing--20:.44rem;--wp--preset--spacing--30:.67rem;--wp--preset--spacing--40:1rem;--wp--preset--spacing--50:1.5rem;--wp--preset--spacing--60:2.25rem;--wp--preset--spacing--70:3.38rem;--wp--preset--spacing--80:5.06rem;--wp--preset--shadow--natural:6px 6px 9px rgba(0,0,0,.2);--wp--preset--shadow--deep:12px 12px 50px rgba(0,0,0,.4);--wp--preset--shadow--sharp:6px 6px 0px rgba(0,0,0,.2);--wp--preset--shadow--outlined:6px 6px 0px -3px rgba(255,255,255,1),6px 6px rgba(0,0,0,1);--wp--preset--shadow--crisp:6px 6px 0px rgba(0,0,0,1);}:where(.is-layout-flex){gap:.5em;}:where(.is-layout-grid){gap:.5em;}body .is-layout-flow > .alignleft{float:left;margin-inline-start:0;margin-inline-end:2em;}body .is-layout-flow > .alignright{float:right;margin-inline-start:2em;margin-inline-end:0;}body .is-layout-flow > .aligncenter{margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > .alignleft{float:left;margin-inline-start:0;margin-inline-end:2em;}body .is-layout-constrained > .alignright{float:right;margin-inline-start:2em;margin-inline-end:0;}body .is-layout-constrained > .aligncenter{margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > :where(:not(.alignleft):not(.alignright):not(.alignfull)){max-width:var(--wp--style--global--content-size);margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > .alignwide{max-width:var(--wp--style--global--wide-size);}body .is-layout-flex{display:flex;}body .is-layout-flex{flex-wrap:wrap;align-items:center;}body .is-layout-flex > *{margin:0;}body .is-layout-grid{display:grid;}body .is-layout-grid > *{margin:0;}:where(.wp-block-columns.is-layout-flex){gap:2em;}:where(.wp-block-columns.is-layout-grid){gap:2em;}:where(.wp-block-post-template.is-layout-flex){gap:1.25em;}:where(.wp-block-post-template.is-layout-grid){gap:1.25em;}.has-black-color{color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-color{color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-color{color:var(--wp--preset--color--white) !important;}.has-pale-pink-color{color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-color{color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-color{color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-color{color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-color{color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-color{color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-color{color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-color{color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-color{color:var(--wp--preset--color--vivid-purple) !important;}.has-black-background-color{background-color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color:var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color:var(--wp--preset--color--vivid-purple) !important;}.has-black-border-color{border-color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color:var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color:var(--wp--preset--color--vivid-purple) !important;}.has-vivid-cyan-blue-to-vivid-purple-gradient-background{background:var(--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple) !important;}.has-light-green-cyan-to-vivid-green-cyan-gradient-background{background:var(--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan) !important;}.has-luminous-vivid-amber-to-luminous-vivid-orange-gradient-background{background:var(--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange) !important;}.has-luminous-vivid-orange-to-vivid-red-gradient-background{background:var(--wp--preset--gradient--luminous-vivid-orange-to-vivid-red) !important;}.has-very-light-gray-to-cyan-bluish-gray-gradient-background{background:var(--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray) !important;}.has-cool-to-warm-spectrum-gradient-background{background:var(--wp--preset--gradient--cool-to-warm-spectrum) !important;}.has-blush-light-purple-gradient-background{background:var(--wp--preset--gradient--blush-light-purple) !important;}.has-blush-bordeaux-gradient-background{background:var(--wp--preset--gradient--blush-bordeaux) !important;}.has-luminous-dusk-gradient-background{background:var(--wp--preset--gradient--luminous-dusk) !important;}.has-pale-ocean-gradient-background{background:var(--wp--preset--gradient--pale-ocean) !important;}.has-electric-grass-gradient-background{background:var(--wp--preset--gradient--electric-grass) !important;}.has-midnight-gradient-background{background:var(--wp--preset--gradient--midnight) !important;}.has-small-font-size{font-size:var(--wp--preset--font-size--small) !important;}.has-medium-font-size{font-size:var(--wp--preset--font-size--medium) !important;}.has-large-font-size{font-size:var(--wp--preset--font-size--large) !important;}.has-x-large-font-size{font-size:var(--wp--preset--font-size--x-large) !important;}.wp-block-navigation a:where(:not(.wp-element-button)){color:inherit;}:where(.wp-block-post-template.is-layout-flex){gap:1.25em;}:where(.wp-block-post-template.is-layout-grid){gap:1.25em;}:where(.wp-block-columns.is-layout-flex){gap:2em;}:where(.wp-block-columns.is-layout-grid){gap:2em;}.wp-block-pullquote{font-size:1.5em;line-height:1.6;}p.wpdmpp-notice{margin:5px;}.wpbtn-success{color:var(--color-success) !important;border-color:var(--color-success) !important;background:rgba(var(--color-success-rgb),.03) !important;transition:all ease-in-out 300ms;}.wpbtn-success:active,.wpbtn-success:hover{color:var(--color-success-active) !important;border-color:var(--color-success-active) !important;background:rgba(var(--color-success-rgb),.07) !important;}.e-con.e-parent:nth-of-type(n+4):not(.e-lazyloaded):not(.e-no-lazyload),.e-con.e-parent:nth-of-type(n+4):not(.e-lazyloaded):not(.e-no-lazyload) *{background-image:none !important;}@media screen and (max-height: 1024px){.e-con.e-parent:nth-of-type(n+3):not(.e-lazyloaded):not(.e-no-lazyload),.e-con.e-parent:nth-of-type(n+3):not(.e-lazyloaded):not(.e-no-lazyload) *{background-image:none !important;}.e-con.e-parent:nth-of-type(n+3):not(.e-lazyloaded):not(.e-no-lazyload).nitro-lazy,.e-con.e-parent:nth-of-type(n+3):not(.e-lazyloaded):not(.e-no-lazyload) *.nitro-lazy{background-image:none !important;}}@media screen and (max-height: 640px){.e-con.e-parent:nth-of-type(n+2):not(.e-lazyloaded):not(.e-no-lazyload),.e-con.e-parent:nth-of-type(n+2):not(.e-lazyloaded):not(.e-no-lazyload) *{background-image:none !important;}.e-con.e-parent:nth-of-type(n+2):not(.e-lazyloaded):not(.e-no-lazyload).nitro-lazy,.e-con.e-parent:nth-of-type(n+2):not(.e-lazyloaded):not(.e-no-lazyload) *.nitro-lazy{background-image:none !important;}}.e-con.e-parent:nth-of-type(n+4):not(.e-lazyloaded):not(.e-no-lazyload).nitro-lazy,.e-con.e-parent:nth-of-type(n+4):not(.e-lazyloaded):not(.e-no-lazyload) *.nitro-lazy{background-image:none !important;}.broken_link,a.broken_link{text-decoration:line-through;}img.attachment-full.size-full.wp-post-image{width:100%;}.tribe-block.tribe-block__event-website a{color:white !important;}.tribe-events-gcal.tribe-events-button{display:none;}.tribe-events-ical.tribe-events-button{display:none;}.tribe-events-c-ical{display:none;}.tribe-events-event-categories-label{display:none;}.tribe-events-event-categories{display:none;}.tribe-events-content p,.tribe-events-content ul li{font-size:14px !important;font-family:Roboto !important;}.tribe-events-event-meta dl{width:200px !important;}.tribe-events-c-events-bar__views{display:none !important;visibility:hidden;}.tribe-events-content a{color:#ac182d !important;border:none !important;}.tribe-events-content a:hover{color:#f09830 !important;border:none !important;}.tribe-events-event-meta a{color:#ac182d !important;border:none !important;}.tribe-events-event-meta a:hover{color:#f09830 !important;border:none !important;}.tribe-related-events-title a{color:#ac182d !important;border:none !important;}.tribe-related-events-title a:hover{color:#f09830 !important;border:none !important;}.tribe-block__event-website a{background-color:#ac182d !important;}.tribe-block__event-website a:hover{background-color:#f09830 !important;}.tribe-block__organizer__website a{color:#ac182d !important;}.tribe-block__organizer__website a:hover{color:#f09830 !important;}.tribe-events-c-subscribe-dropdown{border-color:#ac182d !important;}.tribe-common-c-svgicon{color:white !important;}.tribe-events-c-subscribe-dropdown__button{background-color:#ac182d !important;border-color:#ac182d !important;}.tribe-events-c-subscribe-dropdown__button:hover{background-color:#f09830 !important;color:white !important;border-color:#f09830 !important;}.tribe-events-c-subscribe-dropdown .tribe-events-c-subscribe-dropdown__button-text{background:none !important;border:none !important;color:white !important;}.tribe-events-c-subscribe-dropdown .tribe-events-c-subscribe-dropdown__button-text:hover{color:white !important;}.tribe-events-c-subscribe-dropdown__list-item a{color:#ac182d !important;}.tribe-events-sub-nav li a{background:none !important;color:#ac182d !important;}#tribe-events-footer:before{background-color:#ac182d !important;}html,body{max-width:100%;overflow-x:hidden;}.modal-content .modal-icon img{height:100% !important;}#difer1 .cajablanca,#colnew .cajablanca{background-color:#fff !important;}#difer1 .cajablanca h3,#colnew .cajablanca h3{padding-top:0px;border:0px;margin:0 0 5px 0;font-size:12pt;}#difer1 .cajablanca .media-body span,#colnew .cajablanca .media-body span{font-size:10pt;font-weight:300;}#difer1 .cajablanca .media-body .fa-download i,#colnew .cajablanca .media-body .fa-download i{margin:2px 0 0 5px;opacity:.5;}.cajablanca .media-body span{font-size:10pt !important;font-weight:300 !important;color:#54595f !important;}.w3eden .col-lg-4{margin-bottom:40px !important;}.cajablanca{margin-bottom:5px !important;border:none !important;}.cajablanca h3{font-size:12pt !important;}.w3eden .mb-2{margin-bottom:10px !important;}.w3eden .card{border:none !important;}.w3eden .btn{font-size:.75rem !important;}.w3eden .btn-primary{background-color:#ac182d !important;border-color:#ac182d !important;}.btn-primary:hover{background-color:#f09830 !important;border-color:#f09830 !important;}.w3eden .text-muted i{color:#54595f !important;}.w3eden .text-muted{color:#54595f !important;}#downbro table{border:1px solid #ccc;border-collapse:collapse;margin:0%;padding:0;width:100%;box-shadow:0 1px 3px rgba(0,0,0,.2);display:table;}#downbro table tr{background:#f8f8f8;border:1px solid #ddd;padding:.35em;}#downbro table tr:hover td{background-color:#ddd !important;}#downbro table th,#downbro table td{padding:.625em;text-align:center;}#downbro table th{font-size:.8em;text-transform:uppercase;background:#eee;color:#000;padding:15px 0px;}#downbro .dfile,#downbro .dissue,#downbro .dupdate{width:10%;max-width:100px;vertical-align:middle;}#downbro .dphase{width:15%;max-width:100px;vertical-align:middle;}#downbro .dfile,#downbro .dphase,#downbro .dissue,#downbro .dupdate{overflow-wrap:break-word;word-wrap:break-word;hyphens:auto;vertical-align:middle;}#downbro .dddownload{width:15% !important;max-width:100px;vertical-align:middle;}#downbro .dname1{width:40%;text-align:left;vertical-align:middle;}#downbro .dname{width:40%;text-align:center;vertical-align:middle;}html .media-heading{margin:10px 0 5px 0 !important;}html .w3eden .pagination{padding-top:15px;}#colnew .row > div[class*="col"]{display:inline-block;vertical-align:top;float:none;}.w3eden .blockui:before{content:"";position:absolute;width:100%;height:100%;left:0;top:0;z-index:9999;background:rgba(255,255,255,.4) url("https://chinameddevice.com/download/images/spinner-bars.svg") center center no-repeat;background-size:48px;}.content__footer{display:none !important;}.teaser{transition:transform .5s;}.teaser:hover{transform:scale(1.3);}*{box-sizing:border-box;}.sub_img_link{position:relative;width:100%;max-width:300px;}.sub_txt_overlay{position:absolute;left:9%;bottom:0;background:#000;background:rgba(240,152,48,.85);color:#f1f1f1;color:white;width:82%;transition:.5s ease;opacity:0;font-size:14px;padding:20px;text-align:center;}.sub_img_link:hover .sub_txt_overlay{opacity:1;}.sub_txt_teaser:hover{transition-duration:.5s;font-weight:700;}*{box-sizing:border-box;}.pub_img_link{position:relative;width:100%;max-width:300px;}.pub_txt_overlay{position:absolute;left:9%;bottom:0;background:#000;background:rgba(240,152,48,.85);color:#f1f1f1;color:white;width:82%;transition:.5s ease;opacity:0;font-size:14px;padding:20px;text-align:center;}.pub_img_link:hover .pub_txt_overlay{opacity:1;}.pub_txt_teaser:hover{transition-duration:.5s;font-weight:700;}.dupdate{font-size:13px !important;}:root{--color-primary:#ac182d;--color-primary-rgb:172,24,45;--color-primary-hover:#f09830;--color-secondary:#ac182d;--color-secondary-rgb:172,24,45;--color-secondary-hover:#f09830;--color-success:#ac182d;--color-success-rgb:172,24,45;--color-success-hover:#f09830;--color-info:#ac182d;--color-info-rgb:172,24,45;--color-info-hover:#f09830;--color-warning:#ac182d;--color-warning-rgb:172,24,45;--color-warning-hover:#f09830;--color-danger:#ac182d;--color-danger-rgb:172,24,45;--color-danger-hover:#f09830;--color-green:#30b570;--color-blue:#0073ff;--color-purple:#8557d3;--color-red:#ff5062;--color-muted:rgba(69,89,122,.6);--wpdm-font:"Sen",-apple-system,BlinkMacSystemFont,"Segoe UI",Roboto,Helvetica,Arial,sans-serif,"Apple Color Emoji","Segoe UI Emoji","Segoe UI Symbol";}.wpdm-download-link.btn.btn-primary{border-radius:4px;}.wpdm-popover{transition:all ease-in-out 400ms;position:relative;display:inline-block;}.wpdm-popover .wpdm-hover-card{position:absolute;left:0;bottom:50px;width:100%;transition:all ease-in-out 400ms;margin-bottom:28px;opacity:0;z-index:-999999;}.wpdm-popover:hover .wpdm-hover-card{transition:all ease-in-out 400ms;opacity:1;z-index:999999;bottom:0px;}.wpdm-popover .wpdm-hover-card.hover-preview img{width:104px;border-radius:3px;}.wpdm-popover .card .card-footer{background:rgba(0,0,0,.02);}.packinfo{margin-top:10px;font-weight:400;font-size:14px;}