01-创新医疗器械特别审批程序的实践

创新医疗器械特别审批程序的实践

主要内容Main contents

背景

Background

创新医疗器械特别审批申请审查情况

Status Overview -Special Review/Approval of Innovative MD

创新医疗器械特别审批申请资料关注点

Attentions of application for Special Review and Approval for Innovative Medical Device

背景Background

Launched on Feb 7, 2014

2014年3月1日实施

Became effective on Mar 1, 2014食药监械管〔2014〕13号

创新医疗器械特别审批法规原则

Regulation Principle: Special Review and Approval for Innovative Medical Device •早期介入、专人负责、科学审批

•Early engagement; Designated personnel responsibility;

Scientific review/approval

•标准不降低、程序不减少

Standard not lowered; Procedure not lessened

•优先办理

Dealt with priority

完成审查:565项

565: Completed for examination

进口创新医疗器械申28项Imported ：28申请审查情况概览Status Overview

28

至2017年5月底，CFDA 共受理创新特批申请：590项

CFDA has received 590 applications of special approval by the end of May,2017

受理：590

6