Chinese lucrative medical device market, the first obstacle faced by overseas medical device manufacturers and producers is how to comply with the Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.
1. Medical Device GMP Regulations Market in
China
China is one of the fastest growing global economies with a fourth population in the world, and is one
of the largest healthcare markets around the world. Along with sustained economic and population
growth, Chinese healthcare market has maintained annually average growth rate above 16 % since
1990s. Among them, medical devices represented dynamical growth since 2000s. By 2010, total value
of medical devices on Chinese healthcare market has reached 120 billion RMB. It is estimated that
within the next few years, Chinese medical device market will be likely to be more than 600 billion
RMB, and will surpass Japan to become the second largest medical device market following the United
States. The Chinese medical device market will attract more and more overseas medical device
manufacturers and producers to penetrate such market.
To enter the Chinese lucrative medical device market, the first obstacle faced by overseas medical
device manufacturers and producers is how to comply with the Chinese Good Manufacturing Practice
(GMP) Regulations for Medical Devices. Lack of knowledge of the Chinese laws and administrative
regulations, and the cultural difference between China and Western countries as well as the language
barriers will increase the challenge faced by overseas medical device manufacturers and producers.
Therefore, a comprehensive and thorough knowledge of the latest Chinese Good Manufacturing
Practice (GMP) Regulations for Medical Devices has been become an essential prerequisite for overseas
medical device manufacturers and producers to achieve a successful entry into the Chinese medical
device market, so more and more overseas medical device companies and multinational medical device
companies, and their senior executive officers engaging in regulatory affairs expect to understand the
latest Chinese Medical Device GMP regulations.
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Report Details:
Published: March 2013
No. of Pages: 213
Price: Single User License: US$750 Corporate User License: US$3500
Latest Guide to Chinese Medical Device GMP Regulations is an essential resource for overseas medical
device manufacturers and producers to achieve a successful entry into the Chinese medical device
market, which provides a detailed guidance of comprehensive and thorough knowledge of the latest
Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.
The Chinese regulatory authorities for medical devices, the State Food and Drug Administration(SFDA)
issued the latest Medical Device GMP regulations in December 2009, including the Good Manufacturing
Practice (GMP) for Medical Devices (Interim), the Regulations on Inspection of Good Manufacturing
Practice (GMP) for Medical Devices (Interim), the Implementation Guidelines and Inspection Criteria of
Good Manufacturing Practice (GMP) for Sterile Medical Devices (Interim), and the Implementation
Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical
Devices (Interim), which all came into effect as of January 1, 2011.
2. The organizations of this guidebook are arranged as follows. Chapter 2 provides the organizational
structure of Chinese regulatory authorities for medical device 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-sale service. Chapter 4 introduces the details
of the Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices. Chapter 5
introduces the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice
(GMP) for Sterile Medical Devices in detail. Chapter 6 provides the detailed comprehensive guidance of
Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for
Implantable Medical Devices.
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Guidebook Highlights
An overview of Good Manufacturing Practice (GMP) for Medical Devices.
The details of Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical
Devices.
The Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP)
for Sterile Medical Devices
The Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP)
for Implantable Medical Devices
A full set of the English and Chinese bilingual application and inspection forms of Good
Manufacturing Practice for Medical Devices.
An overview of the entire application and inspection procedure for Medical Device GMP.
The comprehensive inspection items and inspection contents of GMP for Sterile Medical Device
and Implantable Medical Device.
Who should buy this report?
Overseas medical device companies wishing to enter a lucrative drug market in China.
Overseas medical device companies interested in understanding the latest Chinese Medical
Device GMP Regulations.
Senior executive officers engaging in regulatory affairs expecting to understand the latest
Chinese Medical Device GMP regulations.
Senior executive officers engaging in regulatory affairs for quality control, quality assurance, and
production management for medical device manufacture.
Non-Chinese pharmaceutical consultative companies engaging in agent service for application
and inspection of Medical Device GMP with the Chinese government authorities.
Non-Chinese universities, colleges, academic & research institutions.
Non-Chinese university library, public library.
Non-Chinese Chamber of Commerce.
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