Chinas regulatory
framework for in-vitro diagnostic reagents is undergoing earthshaking changes.
It will bring overseas and multinational in-vitro diagnostic reagent
manufacturers the maximum challenges and opportunities. How do you in
compliance with the latest Chinese regulations on in-vitro diagnostic reagents?
How do you operate business smoothly in China? To enter such a lucrative
in-vitro diagnostic reagent market, overseas and multinational in-vitro
diagnostic reagent manufacturers must have a comprehensive and thorough
knowledge of the latest Chinese regulations on in-vitro diagnostic reagent
registration. Otherwise, the restrictive legal requirements and approval delays
eat up your time and energy to achieve a successful entry into such a lucrative
in-vitro diagnostic reagent market, and cause trouble for your business
smoothly in China.
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Latest Chinese
Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent
Registration: From Regulations to Practices
not only provided a comprehensive and thorough knowledge of the latest
Chinese regulations for imported in-vitro diagnostic reagent registration but
also introduced the practical operation how to comply with the Chinese
regulations to guide you achieve a successful approval for your products entry
into the Chinese in-vitro diagnostic reagent market.
Table
Of Content
Chapter 1
Executive Summary.5
Chapter 2
Analysis and Research for Radical Change of Chinese Regulations on In Vitro
Diagnostic Reagents.9
2.1. What the
Chinese regulations on in-vitro diagnostic reagents are undergoing earthshaking
changes?.9
2.2. What is the
reason to drive Chinese regulations on in-vitro diagnostic reagents radical
change?.11
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Chapter 3 Latest
Chinese Applicable Regulations for In-vitro Diagnostic Reagent Registration.14
Chapter 4 An
Overview of Chinese Regulatory Authorities for Imported In-vitro Diagnostic
Reagent Registration.17
4.1. CFDAs Main
Responsibilities.17
4.2. CFDAs
Organizational Structure.20
Chapter 5
General Regulations for Imported In-vitro Diagnostic Reagent Registration.28
5.1. Definitions.29
5.2. Classified
Administration for Registration and Recordation of In-vitro Diagnostic
Reagents.30
5.3. What in-vitro
diagnostic reagents may be exported into China?31
5.4. Regulations on
Applicant or Filer for Imported In-vitro Diagnostic Reagent Registration or
Recordation.31
5.5. Product
Technical Requirements.32
Chapter 6
Classification and Naming Principles for In-vitro Diagnostic Reagents.39
6.1. Classification
for In-vitro Diagnostic Reagents.39
6.2. Naming
Principles for In-vitro Diagnostic Reagents.46
Chapter 7
Clinical Trials of In-vitro Diagnostic Reagents.46
7.1. Basic
Principles of Clinical Trials.47
7.2. Principles of
Clinical Trial Design.49
7.3. Clinical Trial
Report.54
7.4. Clinical Trial
Protocol.57
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