DUBLIN--(BUSINESS WIRE)--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