LONDON--(BUSINESS WIRE)--By the end of 2015, China’s in-vitro diagnostic (IVD) reagent market is likely to reach more than 20.8 billion RMB, attracting more and more in-vitro diagnostic reagents produced abroad. To penetrate such a lucrative market, various overseas in-vitro diagnostic reagents manufacturers and producers should be aware of how to file the application for their imported in-vitro diagnostic reagent registration with Chinese regulatory authorities for in-vitro diagnostic reagents. Also, among other obstacles faced by a variety of these manufacturers and producers one can name the lack of knowledge of the Chinese laws and administrative regulations, the cultural difference between China and Western countries as well as the language barriers.
New research report “China’s Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration” developed by Access China Management Consulting (Access China) provides not only a detailed guidance of practical operation for application and approval of imported in-vitro diagnostic reagent registration but also comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported in-vitro diagnostic reagent registration to guide overseas in-vitro diagnostic reagents manufacturers and producers to pass through the entirely legal procedures of application and approval for imported in-vitro diagnostic reagent registration smoothly.
Report Details:
Title: China’s Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration
Published: March, 2012
Pages: 179
Price: US$ 750
Report Contents:
PREFACE
TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY
CHAPTER 2 AN OVERVIEW OF CHINESE REGULATORY AUTHORITIES FOR MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC REAGENTS - STATE FOOD AND DRUG ADMINISTRATION (SFDA)
2.1. SFDA’s Main Responsibilities
2.2. SFDA’s Organization Structure
Figure 2.2. SFDA’s Organization Structure
Table 2.2. SFDA’s Affiliated Organizations
CHAPTER 3 CHINESE LAWS AND REGULATIONS FOR IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
3.1. Chinese Legislation
3.2. Latest Applicable Administrative Regulations, and Departmental Regulations, Provisions, Measures, and Guidance for In-vitro Diagnostic Reagent Registration
CHAPTER 4 GENERAL REGULATIONS FOR APPLICATION AND APPROVAL OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
4.1. Definitions
4.2. Regulatory Authorities for In-vitro Diagnostic Reagents
4.3. Classified Registration and Administration of In-vitro Diagnostic Reagents
…
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