China has an indispensable in-vitro diagnostic reagent market for overseas and multinational in-vitro diagnostic reagent companies. Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, in-vitro diagnostic reagents represented dynamical growth since 2007. By 2014, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 4.3 billion US dollars. The in-vitro diagnostic reagents have been widely used in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction. On the Chinese in-vitro diagnostic reagent market, imported overseas in-vitro diagnostic reagents made by overseas and multinational in-vitro diagnostic reagent manufacturers accounted for about a half, in which the high-tech and high-valued in-vitro diagnostic reagents are almost monopolized by the American Life Technologies, Roche, Abbott, Siemens, Beja Asian capital and other overseas and multinational companies. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 5.68 billion US dollars until 2015, and it is one of segment market of the most growth potentiality.

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However, since October 2014, Chinese regulatory authorities have significantly changed the regulations on in-vitro diagnostic reagents. China Food and Drug Administration (CFDA) issued the latest Chinese Good Manufacturing Practice (GMP) for Medical Devices on December 29, 2014, which has come into force as March 1, 2015. On July 10, 2015, China Food and Drug Administration (CFDA) further issued the latest Implementation Regulations of Good Manufacturing Practice (GMP) for In–vitro Diagnosis Reagents as the appendices of the latest Chinese Good Manufacturing Practice (GMP) for Medical Devices, which has come into force as October 1, 2015. Furthermore, on September 25, 2015, China Food and Drug Administration (CFDA) issued the On-site Inspection Guideline of Good Manufacturing Practice (GMP) for Medical Devices, On-site Inspection Guideline for In–vitro Diagnosis Reagent GMP Implementation Regulations respectively. Everything changed.

China Food and Drug Administration (CFDA) requests that all the newly established in-vitro diagnostic reagent manufacturers, the existing in-vitro diagnostic reagent manufacturers to increase production of Class III in-vitro diagnostic reagents, the relocated in-vitro diagnostic reagent manufacturers or the in-vitro diagnostic reagent manufacturers to expand manufacturing sites should follow the requirements of the latest Good Manufacturing Practice (GMP) Regulations for Medical Devices and the latest Implementation Regulations of Good Manufacturing Practice (GMP) for In–vitro Diagnosis Reagents. Since January 1, 2016, the in-vitro diagnostic reagent manufacturers to manufacture Class III in-vitro diagnostic reagents must comply with the the requirements of the latest Good Manufacturing Practice (GMP) Regulations for Medical Devices and the latest Implementation Regulations of Good Manufacturing Practice (GMP) for In–vitro Diagnosis Reagents. Since January 1, 2018, all the in-vitro diagnostic reagent manufacturers must comply with the requirements of the latest Good Manufacturing Practice (GMP) Regulations for Medical Devices and the latest Implementation Regulations of Good Manufacturing Practice (GMP) for In–vitro Diagnosis Reagents.Those manufacturers that do not meet those deadlines may face enforcement actions by the food and drug regulatory authorities.

At present, overseas and multinational in-vitro diagnostic reagent manufacturers, as well as domestic in-vitro diagnostic reagent manufacturers are confronting with multiple inspection and verification of GMP rules and the relevant assorted GMP implementation regulations. The overseas in-vitro diagnostic reagent manufacturers exporting Class II and Class III overseas in-vitro diagnostic reagents into Chinese in-vitro diagnostic reagent market, they must be subject to examination and approval of registration license, as well as the inspection and verification of GMP rules by the CFDA directly under the State Council. The multinational in-vitro diagnostic reagent manufacturers have penetrated into the Chinese in-vitro diagnostic reagent market, their affiliated manufacturers within territory of China must be subject to not only the examination and approval of registration license and production license, as well as on-site inspection and verification of GMP rules and the relevant assorted GMP implementation regulations, but also on-site inspections of GMP rules for various supervisions and enforcements, such as the routine supervision and enforcement, the follow-up supervision and enforcement, the surprise spot-check for “special issues”, and so on.

The on-site inspection of GMP rules and the relevant assorted GMP implementation regulations is an extremely stringent inspection and verification process of GMP rules and the relevant assorted GMP implementation regulations for in-vitro diagnostic reagent manufacturing enterprise. The regulatory authorities will dispatch the inspection team to conduct the on-site inspection by the manner of article to article, clause to clause in accordance with the GMP rules and the relevant assorted GMP implementation regulations to verify whether the in-vitro diagnostic reagent manufacturing enterprise is compliance with the GMP rules and the relevant assorted GMP implementation regulations.

How do you in compliance with the latest Chinese in-vitro diagnostic reagent GMP regulations? How do you operate business smoothly in China? The overseas and multinational in-vitro diagnostic reagent manufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the latest Chinese in-vitro diagnostic reagent GMP regulations. Otherwise, the restrictive legal requirements and approval delays will 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.

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 throug the extremely stringent on-site inspection and verification process of GMP rules and the relevant assorted GMP implementation regulations.

The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of organizational structure of Chinese regulatory authorities for In-vitro Diagnostic Reagent GMP regulations. Chapter 3 provides an overview of Good Manufacturing Practice (GMP) for Medical Devices, which are comprehensive regulations to regulate a manufacturer’s quality management system throughout the process from design, development and manufacturing to sales and after-sales service. Chapter 4 introduces the detailed Implementation Regulations of Good Manufacturing Practice (GMP) for In-vitro Diagnostic Reagents. Chapter 5 elaborates the on-site inspection of Good Manufacturing Practice (GMP) for in-vitro diagnostic reagents to smoothly navigate complex regulatory requirements step by step. Chapter 6 elaborates the 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.

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.”

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