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China’s Regulatory Approach to Software as a Medical Device (SaMD): GMP & Inspection Guidance

September 3, 2024

Historic Changes Proposed for Medical Devices in China: Seven Key Areas Foreign Companies Should Watch

September 3, 2024

NMPA’s New Device Classification Rules Take Effect September 1, 2024

August 26, 2024

NMPA (CFDA) Monthly Newsletters

The Monthly NMPA (CFDA) Newsletter covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China.

202311 NMPA 28CFDA 29 News Roundup

UPDATED: February 15, 2024 5

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2021 China NMPA (CFDA) Bluebook

UPDATED: February 25, 2021 204

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[class*=indicator--shape-]:not(.e-form__indicators__indicator--shape-none){background-color:var(--e-form-steps-indicator-active-secondary-color,#fff);}.e-form__indicators__indicator--state-active object,.e-form__indicators__indicator--state-active svg{fill:var(--e-form-steps-indicator-active-primary-color,#39b54a);}.e-form__indicators__indicator--state-completed{color:var(--e-form-steps-indicator-completed-secondary-color,#fff);}.e-form__indicators__indicator--state-completed [class*=indicator--shape-]:not(.e-form__indicators__indicator--shape-none){background-color:var(--e-form-steps-indicator-completed-primary-color,#39b54a);}.e-form__indicators__indicator--state-completed .e-form__indicators__indicator__label{color:var(--e-form-steps-indicator-completed-primary-color,#39b54a);}.e-form__indicators__indicator--state-completed .e-form__indicators__indicator--shape-none{color:var(--e-form-steps-indicator-completed-primary-color,#39b54a);background-color:initial;}.e-form__indicators__indicator--state-completed object,.e-form__indicators__indicator--state-completed svg{fill:var(--e-form-steps-indicator-completed-secondary-color,#fff);}.e-form__indicators__indicator__icon{width:var(--e-form-steps-indicator-padding,30px);height:var(--e-form-steps-indicator-padding,30px);font-size:var(--e-form-steps-indicator-icon-size);border-width:1px;border-style:solid;display:flex;justify-content:center;align-items:center;overflow:hidden;margin-bottom:10px;}.e-form__indicators__indicator__icon img,.e-form__indicators__indicator__icon object,.e-form__indicators__indicator__icon svg{width:var(--e-form-steps-indicator-icon-size);height:auto;}.e-form__indicators__indicator__icon .e-font-icon-svg{height:1em;}.e-form__indicators__indicator__number{width:var(--e-form-steps-indicator-padding,30px);height:var(--e-form-steps-indicator-padding,30px);border-width:1px;border-style:solid;display:flex;justify-content:center;align-items:center;margin-bottom:10px;}.e-form__indicators__indicator--shape-circle{border-radius:50%;}.e-form__indicators__indicator--shape-square{border-radius:0;}.e-form__indicators__indicator--shape-rounded{border-radius:5px;}.e-form__indicators__indicator--shape-none{border:0;}.e-form__indicators__indicator__label{text-align:center;}.e-form__indicators__indicator__separator{width:100%;height:var(--e-form-steps-divider-width);background-color:#babfc5;}.e-form__indicators--type-icon,.e-form__indicators--type-icon_text,.e-form__indicators--type-number,.e-form__indicators--type-number_text{align-items:flex-start;}.e-form__indicators--type-icon .e-form__indicators__indicator__separator,.e-form__indicators--type-icon_text .e-form__indicators__indicator__separator,.e-form__indicators--type-number .e-form__indicators__indicator__separator,.e-form__indicators--type-number_text .e-form__indicators__indicator__separator{margin-top:calc(var(--e-form-steps-indicator-padding,30px) / 2 - var(--e-form-steps-divider-width,1px) / 2);}.elementor-field-type-hidden{display:none;}.elementor-field-type-html{display:inline-block;}.elementor-field-type-tel input{direction:inherit;}.elementor-login .elementor-lost-password,.elementor-login .elementor-remember-me{font-size:.85em;}.elementor-field-type-recaptcha_v3 .elementor-field-label{display:none;}.elementor-field-type-recaptcha_v3 .grecaptcha-badge{z-index:1;}.elementor-button .elementor-form-spinner{order:3;}.elementor-form .elementor-button>span{display:flex;justify-content:center;align-items:center;}.elementor-form .elementor-button .elementor-button-text{white-space:normal;flex-grow:0;}.elementor-form .elementor-button svg{height:auto;}.elementor-form .elementor-button .e-font-icon-svg{height:1em;}.elementor-select-wrapper .select-caret-down-wrapper{position:absolute;top:50%;transform:translateY(-50%);inset-inline-end:10px;pointer-events:none;font-size:11px;}.elementor-select-wrapper .select-caret-down-wrapper svg{display:unset;width:1em;aspect-ratio:unset;fill:currentColor;}.elementor-select-wrapper .select-caret-down-wrapper i{font-size:19px;line-height:2;}.elementor-select-wrapper.remove-before:before{content:"" !important;}.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff;}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent;}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px;}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em;}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px;}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block;}.elementor-widget-social-icons.elementor-grid-0 .elementor-widget-container,.elementor-widget-social-icons.elementor-grid-mobile-0 .elementor-widget-container,.elementor-widget-social-icons.elementor-grid-tablet-0 .elementor-widget-container{line-height:1;font-size:0;}.elementor-widget-social-icons:not(.elementor-grid-0):not(.elementor-grid-tablet-0):not(.elementor-grid-mobile-0) .elementor-grid{display:inline-grid;}.elementor-widget-social-icons .elementor-grid{grid-column-gap:var(--grid-column-gap,5px);grid-row-gap:var(--grid-row-gap,5px);grid-template-columns:var(--grid-template-columns);justify-content:var(--justify-content,center);justify-items:var(--justify-content,center);}.elementor-icon.elementor-social-icon{font-size:var(--icon-size,25px);line-height:var(--icon-size,25px);width:calc(var(--icon-size,25px) + 2 * var(--icon-padding,.5em));height:calc(var(--icon-size,25px) + 2 * var(--icon-padding,.5em));}.elementor-social-icon{--e-social-icon-icon-color:#fff;display:inline-flex;background-color:#69727d;align-items:center;justify-content:center;text-align:center;cursor:pointer;}.elementor-social-icon i{color:var(--e-social-icon-icon-color);}.elementor-social-icon svg{fill:var(--e-social-icon-icon-color);}.elementor-social-icon:last-child{margin:0;}.elementor-social-icon:hover{opacity:.9;color:#fff;}.elementor-social-icon-android{background-color:#a4c639;}.elementor-social-icon-apple{background-color:#999;}.elementor-social-icon-behance{background-color:#1769ff;}.elementor-social-icon-bitbucket{background-color:#205081;}.elementor-social-icon-codepen{background-color:#000;}.elementor-social-icon-delicious{background-color:#39f;}.elementor-social-icon-deviantart{background-color:#05cc47;}.elementor-social-icon-digg{background-color:#005be2;}.elementor-social-icon-dribbble{background-color:#ea4c89;}.elementor-social-icon-elementor{background-color:#d30c5c;}.elementor-social-icon-envelope{background-color:#ea4335;}.elementor-social-icon-facebook,.elementor-social-icon-facebook-f{background-color:#3b5998;}.elementor-social-icon-flickr{background-color:#0063dc;}.elementor-social-icon-foursquare{background-color:#2d5be3;}.elementor-social-icon-free-code-camp,.elementor-social-icon-freecodecamp{background-color:#006400;}.elementor-social-icon-github{background-color:#333;}.elementor-social-icon-gitlab{background-color:#e24329;}.elementor-social-icon-globe{background-color:#69727d;}.elementor-social-icon-google-plus,.elementor-social-icon-google-plus-g{background-color:#dd4b39;}.elementor-social-icon-houzz{background-color:#7ac142;}.elementor-social-icon-instagram{background-color:#262626;}.elementor-social-icon-jsfiddle{background-color:#487aa2;}.elementor-social-icon-link{background-color:#818a91;}.elementor-social-icon-linkedin,.elementor-social-icon-linkedin-in{background-color:#0077b5;}.elementor-social-icon-medium{background-color:#00ab6b;}.elementor-social-icon-meetup{background-color:#ec1c40;}.elementor-social-icon-mixcloud{background-color:#273a4b;}.elementor-social-icon-odnoklassniki{background-color:#f4731c;}.elementor-social-icon-pinterest{background-color:#bd081c;}.elementor-social-icon-product-hunt{background-color:#da552f;}.elementor-social-icon-reddit{background-color:#ff4500;}.elementor-social-icon-rss{background-color:#f26522;}.elementor-social-icon-shopping-cart{background-color:#4caf50;}.elementor-social-icon-skype{background-color:#00aff0;}.elementor-social-icon-slideshare{background-color:#0077b5;}.elementor-social-icon-snapchat{background-color:#fffc00;}.elementor-social-icon-soundcloud{background-color:#f80;}.elementor-social-icon-spotify{background-color:#2ebd59;}.elementor-social-icon-stack-overflow{background-color:#fe7a15;}.elementor-social-icon-steam{background-color:#00adee;}.elementor-social-icon-stumbleupon{background-color:#eb4924;}.elementor-social-icon-telegram{background-color:#2ca5e0;}.elementor-social-icon-threads{background-color:#000;}.elementor-social-icon-thumb-tack{background-color:#1aa1d8;}.elementor-social-icon-tripadvisor{background-color:#589442;}.elementor-social-icon-tumblr{background-color:#35465c;}.elementor-social-icon-twitch{background-color:#6441a5;}.elementor-social-icon-twitter{background-color:#1da1f2;}.elementor-social-icon-viber{background-color:#665cac;}.elementor-social-icon-vimeo{background-color:#1ab7ea;}.elementor-social-icon-vk{background-color:#45668e;}.elementor-social-icon-weibo{background-color:#dd2430;}.elementor-social-icon-weixin{background-color:#31a918;}.elementor-social-icon-whatsapp{background-color:#25d366;}.elementor-social-icon-wordpress{background-color:#21759b;}.elementor-social-icon-x-twitter{background-color:#000;}.elementor-social-icon-xing{background-color:#026466;}.elementor-social-icon-yelp{background-color:#af0606;}.elementor-social-icon-youtube{background-color:#cd201f;}.elementor-social-icon-500px{background-color:#0099e5;}.elementor-shape-rounded .elementor-icon.elementor-social-icon{border-radius:10%;}.elementor-shape-circle .elementor-icon.elementor-social-icon{border-radius:50%;}.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;}#wpdm-modal-body img{max-width:100% !important;}.wpdm-placeholder{display:none;}

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