CFDA Medical Device Clinical Trial Regulations Updated by the Year of 2017 - Regulatory News - Medical Devices

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:醫療器械臨床試驗質量管理規范	03/23/2016	Quality Management Standard & Guideline
02	Medical Device Clinical Evaluation Technical Guideline CN:醫療器械臨床評價技術指導原則	05/19/2015
03	In Vitro Diagnostic Reagent Clinical Trial Technical Guideline. CN:體外診斷試劑臨床試驗技術指導原則	09/11/2014
04	Cochlear Implant System Clinical Trial Technical Guideline. CN:人工耳蝸植入系統臨床試驗技術指導原則	01/06/2017
05	The Announcement about Implement ‘Medical Device Registration Management Method’ and ‘In Vitro Diagnostic Reagent Registration Management Method’ CN:關于實施《醫療器械注冊管理辦法》和《體外診斷試劑注冊管理辦法》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:關于醫療器械（含體外診斷試劑）注冊申報有關問題的公告（第129號）	11/25/2014
07	The Announcement about the In Vitro Diagnostic Reagent Clinical Trial Intuition Stamp Related Matters CN:關于體外診斷試劑臨床試驗機構蓋章有關事宜的公告（第154號）	09/09/2015
08	The Announcement about Fill Clinical Trial Intuition Information on the Medical Device Application Form( the 179^th ) CN:關于醫療器械注冊申請表填寫臨床試驗機構信息公告（第179號）	10/28/2016
09	‘Catalog of Class II Medical Devices Exempted from Clinical Trials” CN:免于進行臨床試驗的第二類醫療器械目錄	08/21/2014	Clinical Exempted Catalog
10	‘Catalog of Class III Medical Devices Exempted from Clinical Trials” CN:免于進行臨床試驗的第三類醫療器械目錄	08/21/2014
11	‘Second Batch Catalog of Medical Devices Exempted from Clinical Trials' CN:第二批免于進行臨床試驗醫療器械目錄	09/30/2016
12	Class III Medical Devices that Need to Conduct Clinical Trial Approval Catalog CN:需進行臨床試驗審批的第三類醫療器械目錄	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:《醫療器械臨床試驗倫理審查申請與審批表范本》等六個文件	03/23/2016
14	Medical Device Clinical Trial Record Related Matters CN:醫療器械臨床試驗備案有關事宜	07/03/2015
15	Medical Device Clinical Trial Intuitions Requirement and Record Management Method (Exposure Draft) CN:關于征求《醫療器械臨床試驗機構條件和備案管理辦法（征求意見稿）》意見的函	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:關于征求《免于進行臨床試驗的第二類體外診斷試劑目錄（第二批）》和《免于進行臨床試驗的體外診斷臨床評價資料基本要求》意見的函	05/24/2017	Clinical Exemption Exposure Draft
17	Third Batch Catalog of Medical Devices Exempted from Clinical Trials(Exposure Draft) CN:關于征求第三批免于進行臨床試驗醫療器械目錄意見的函	05/17/2017	Clinical Exemption Exposure Draft
18	CFDA ‘The management method of qualification determination of medical devices clinical Trial institutions’ (Exposure Draft) CN:國家食品藥品監督管理總局關于公開征求《醫療器械臨床試驗機構資質認定管理辦法》（征求意見稿）意見的通知	07/20/2015
19	CFDA Announcement about Conducting Medical Device Clinical Trial Random Inspection (2016, the 98^th) CN:總局關于開展醫療器械臨床試驗監督抽查工作的通告（2016年第98號）	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:總局關于征求《關于鼓勵藥品醫療器械創新改革臨床試驗管理的相關政策》（2017年第53號）	05/11/2017
21	Declaration of Helsinki 2013 CN:赫爾辛基宣言2013（中英文）

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