Research and Markets: Latest Guidebook for Chinese In-vitro Diagnostic Reagent GMP Regulations Featuring Abbott, American Life Technologies, Beja Asian Capital, Roche & Siemens
November 24, 2015 | By Business Wire News
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20151124005970/en/
Research and Markets
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