CFDA Medical Device Clinical Trial Regulations Updated by the Year of 2017

By the first half year of 2017, China Food and Drug Administration (CFDA) already issued many medical device clinical trial related regulations, announcements, guideline and etc.

Here are the detailed list of medical device clinical trial related regulations, announcements, guideline and etc. updated by 2017.

No.	Name of the Documents	Issued date	Catagory
01	Medical Device Clinical Trial Quality Management Standard CN:医疗器械临床试验质量管理规范	03/23/2016	Quality Management Standard & Guideline
02	Medical Device Clinical Evaluation Technical Guideline CN:医疗器械临床评价技术指导原则	05/19/2015
03	In Vitro Diagnostic Reagent Clinical Trial Technical Guideline. CN:体外诊断试剂临床试验技术指导原则	09/11/2014
04	Cochlear Implant System Clinical Trial Technical Guideline. CN:人工耳蜗植入系统临床试验技术指导原则	01/06/2017
05	The Announcement about Implement ‘Medical Device Registration Management Method’ and ‘In Vitro Diagnostic Reagent Registration Management Method’ CN:关于实施《医疗器械注册管理办法》和《体外诊断试剂注册管理办法》的通知	08/01/2014	Announcement
06	The Announcement about Medical Device (including in vitro diagnostic reagent) Registration Declaration Problems( the 129^th ) CN:关于医疗器械（含体外诊断试剂）注册申报有关问题的公告（第129号）	11/25/2014
07	The Announcement about the In Vitro Diagnostic Reagent Clinical Trial Intuition Stamp Related Matters CN:关于体外诊断试剂临床试验机构盖章有关事宜的公告（第154号）	09/09/2015
08	The Announcement about Fill Clinical Trial Intuition Information on the Medical Device Application Form( the 179^th ) CN:关于医疗器械注册申请表填写临床试验机构信息公告（第179号）	10/28/2016
09	‘Catalog of Class II Medical Devices Exempted from Clinical Trials” CN:免于进行临床试验的第二类医疗器械目录	08/21/2014	Clinical Exempted Catalog
10	‘Catalog of Class III Medical Devices Exempted from Clinical Trials” CN:免于进行临床试验的第三类医疗器械目录	08/21/2014
11	‘Second Batch Catalog of Medical Devices Exempted from Clinical Trials' CN:第二批免于进行临床试验医疗器械目录	09/30/2016
12	Class III Medical Devices that Need to Conduct Clinical Trial Approval Catalog CN:需进行临床试验审批的第三类医疗器械目录	08/25/2014	Clinical Trial Record, Approval Related Matters
13	Six Documents including ‘Medical Device Clinical Trial Ethical Review Application and Approval Form Sample’ CN:《医疗器械临床试验伦理审查申请与审批表范本》等六个文件	03/23/2016
14	Medical Device Clinical Trial Record Related Matters CN:医疗器械临床试验备案有关事宜	07/03/2015
15	Medical Device Clinical Trial Intuitions Requirement and Record Management Method (Exposure Draft) CN:关于征求《医疗器械临床试验机构条件和备案管理办法（征求意见稿）》意见的函	08/04/2017
16	Catalog of Class II In Vitro Diagnostic Reagent Exempted from Clinical Trials (Exposure Draft) & The Basic Requirement of Clinical Evaluation Documents for In Vitro Diagnostic Reagent Exempted from Clinical Trials(Exposure Draft) CN:关于征求《免于进行临床试验的第二类体外诊断试剂目录（第二批）》和《免于进行临床试验的体外诊断临床评价资料基本要求》意见的函	05/24/2017	Clinical Exemption Exposure Draft
17	Third Batch Catalog of Medical Devices Exempted from Clinical Trials(Exposure Draft) CN:关于征求第三批免于进行临床试验医疗器械目录意见的函	05/17/2017	Clinical Exemption Exposure Draft
18	CFDA ‘The management method of qualification determination of medical devices clinical Trial institutions’ (Exposure Draft) CN:国家食品药品监督管理总局关于公开征求《医疗器械临床试验机构资质认定管理办法》（征求意见稿）意见的通知	07/20/2015
19	CFDA Announcement about Conducting Medical Device Clinical Trial Random Inspection (2016, the 98^th) CN:总局关于开展医疗器械临床试验监督抽查工作的通告（2016年第98号）	06/08/2016	Expired file as a reference
20	CFDA About Encourage Medicine , Medical Device Innovation Reform Clinical Trial Management Related Policies(2017, the 53th) CN:总局关于征求《关于鼓励药品医疗器械创新改革临床试验管理的相关政策》（2017年第53号）	05/11/2017
21	Declaration of Helsinki 2013 CN:赫尔辛基宣言2013（中英文）

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