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Regulations

China CFDA issued 5 regulation of Medical Device and In-vitro Diagnostics

《Regulationsof the supervision and manufactureof medical devices》(CFDA NO 7 ORDER)http: www sda gov cn WS01 CL0053 103759 html《Regulationsof IVD registration》(CFDA NO 5 ORDER)
Provisions for IVD Registration - China CFDA Order No 5

Chapter 1 General ProvisionsArticle 2 Where any IVD reagent is sold or used within the territory of the People’s Republic of China, it shall apply for the registration
Regulations for the Supervision and Administration of Medical Devices (State Order No.650)

The Regulation hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety Article 2The food and drug re
Application Dossier of China CFDA (SFDA) for In Vitro Diagnostics (IVD) Reagent Products

CFDA releases guidance on IVD reagent surveillance

The format of China CFDA In Vitro Diagnostics (IVD) Reagent Approval license

Related Regulation about In Vitro Diagnostics (IVD) Reagent Approval in China CFDA

2 Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA Order No 5 2014)4 The Guidelines for the Clinical Trial of In Vitro Diagnostic Reagent
Classification for In Vitro Diagnostics (IVD) Reagent in China CFDA

(Ⅰ) Class Ⅰ2 Products for sample processing, e g hemolytic agent, diluents, staining solution, etc Except defined specially as Class Ⅰ and Ⅲ, the products belong to
Notification on China CFDA will charge the registration fee since 27 May 2015

Issue date: May 27, 2015Notice is hereby given 1 Charging Standard for Registration Fees of Drugs and Medical Device Products(3) Detailed Implementation Rules for Medical
Regulation for charging registration fee

Enforcement Regulations for Charging on Registration of Medical Instrument Products(On Trial)
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