Research and Markets: Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/ff3znq/latest_chinese) has announced the addition of the "Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)" report to their offering.

The practical guidance for alteration registration and renewal registration of imported overseas in-vitro diagnostic reagents, also from how to compile application documents to how to submit application documents step by step.

A complete set of full text in English of the latest Chinese regulations for imported overseas in-vitro diagnostic reagent registration, which cover Regulations for the Supervision and Administration of Medical Devices, Measures for the Administration of In Vitro Diagnostic Reagent Registration, Rules for Medical Device Classification, Technical Guidance Principles for Clinical Trials of In--vitro Diagnostic Reagents and Guidance Principles for Compilation of Instruction of In--vitro Diagnostic Reagents .

The audiences of this guidebook are overseas in-vitro diagnostic reagent manufacturers wishing to enter into the Chinese in-vitro diagnostic reagent market, and multinational in-vitro diagnostic reagent companies have penetrated into the Chinese in-vitro diagnostic reagent market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their in-vitro diagnostic reagent products in China, how to comply with the latest Chinese regulations for in-vitro diagnostic reagent registration. After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest Chinese regulations on imported in-vitro diagnostic reagent registration but also the practical operation how to comply with the latest Chinese regulations.

Key Topics Covered:

Chapter 1 Executive Summary.

Chapter 2 Analysis and Research for Radical Change of Chinese Regulations on In Vitro Diagnostic Reagents

Chapter 3 Latest Chinese Applicable Regulations for In-vitro Diagnostic Reagent Registration

Chapter 4 An Overview of Chinese Regulatory Authorities for Imported In-vitro Diagnostic Reagent Registration

Chapter 5 General Regulations for Imported In-vitro Diagnostic Reagent Registration

Chapter 6 Classification and Naming Principles for In-vitro Diagnostic Reagents

Chapter 7 Clinical Trials of In-vitro Diagnostic Reagents

Chapter 8. Compilation of Instruction of In--vitro Diagnostic Reagent Registration

Chapter 9 Application for Imported In--vitro Diagnostic Reagent Recordation

Chapter 10 Application and Approval for Imported In--vitro Diagnostic Reagent Registration

Chapter 11 Application and Approval for Alteration Registration of Imported In-vitro Diagnostic Reagents

Chapter 12 Application and Approval for Renewal Registration of Imported In-vitro Diagnostic Reagents

Chapter 13 Supervision and Administration for Application and Approval of Imported In-vitro Diagnostic Reagent Registration and Recordation

Chapter 14 Practical Guidance for Application of Imported In-vitro Diagnostic Reagent Recordation

Chapter 15 Practical Guidance for Application and Approval of Imported In-vitro Diagnostic Reagent Registration

Chapter 16 Practical Guidance for Alteration Registration and Renewal Registration of Imported In vitro Diagnostic Reagent

Chapter 17 Appendices

For more information visit http://www.researchandmarkets.com/research/ff3znq/latest_chinese

Contacts

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press@researchandmarkets.com
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Sector: Pharmaceuticals

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals