Research and Markets: Latest Guidebook for Chinese In-vitro Diagnostic Reagent GMP Regulations Featuring Abbott, American Life Technologies, Beja Asian Capital, Roche & Siemens

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/2lzcsz/latest_guidebook) has announced the addition of the "Latest Guidebook for Chinese In-vitro Diagnostic Reagent GMP Regulations" report to their offering.

Latest Guidebook for Chinese In-vitro Diagnostic Reagent GMP Regulations is an essential resource for overseas and multinational in-vitro diagnostic reagent manufacturers to achieve a successful entry into the Chinese in-vitro diagnostic reagent market, and to operate business smoothly in China, which provides not only a comprehensive and thorough knowledge of the latest Chinese In-vitro Diagnostic Reagent GMP Regulations, but also the practical operation how to comply with the latest Chinese In-vitro Diagnostic Reagent GMP Regulations, how to smoothly pass through the extremely stringent on-site inspection and verification process of GMP rules and the relevant assorted GMP implementation regulations.

Report Highlights

- An overview of organizational structure of Chinese regulatory authorities for medical device GMP regulations.

- An overview of Good Manufacturing Practice (GMP) for Medical Devices, which are comprehensive regulations to regulate a manufacturer's quality management system covering the entire process from design, development and manufacturing to sales and after-sales service.

- The detailed Implementation Regulations of Good Manufacturing Practice (GMP) for In-vitro Diagnostic Reagents.

- The overall provisions of on-site inspection and verification of Good Manufacturing Practice (GMP) for in-vitro diagnostic reagents to smoothly navigate complex regulatory requirements step by step.

- The comprehensive and detailed on-site inspection items and contents of Good Manufacturing Practice (GMP) for In-vitro Diagnostic Reagents to help overseas and multinational in-vitro diagnostic reagent companies to understand extraordinarily complex inspection requirements by article to article and clause to clause.

Key Topics Covered:

Chapter 1 Executive Summary.

Chapter 2 Chinese Regulatory Authorities for Medical Device GMP Regulations.

Chapter 3 An Overview of Good Manufacturing Practice (GMP) for Medical Devices

Chapter 4 Implementation Regulations of Good Manufacturing Practice (GMP) for In-vitro Diagnostic Reagents

Chapter 5 On-site Inspection of Good Manufacturing Practice (GMP) for In-vitro Diagnostic Reagents

Chapter 6 Inspection Items and Inspection Contents for In-vitro Diagnostic Reagent GMP Implementation Regulations

Companies Mentioned

- Abbott

- American Life Technologies

- Beja Asian capital

- Roche

- Siemens

For more information visit http://www.researchandmarkets.com/research/2lzcsz/latest_guidebook

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: In Vitro Diagnostics

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: In Vitro Diagnostics