Summary
China
is one of the fastest growing global economies with a fifth population in the
world, and is one of the largest healthcare markets around the world. Along
with sustained economic and population growth as well as an ageing population,
Chinese healthcare market has maintained annually average growth rate above 16
% since 1990s. Among them, medical devices represented dynamical growth since
2000s. By 2014, total value of medical devices on Chinese healthcare market has
reached 255.6 billion RMB (about 40.25 billion US dollars). Medical devices
have been widely used in the process of disease prevention, diagnosis, therapy,
care and rehabilitation. On the Chinese medical device market, imported
overseas medical devices made by overseas and multinational medical device
manufacturers account for about a half, in which the high-tech and high-valued
medical devices, such as magnetic resonance imaging (MRI) equipments, computed
tomography (CT) equipments are almost monopolized by GE, Siemens, Philips and
other overseas and multinational companies. It is estimated that Chinese
medical device market will be likely to be more than 340 billion RMB (about
53.15 billion US dollars) by 2015, and will surpass Japan to become the second
largest medical device market behind the United States. Undoubtedly, China has
an indispensable medical device market for overseas and multinational medical
device companies. It’s definitely a field worth playing on.
Get Full
Details On: http://www.radiantinsights.com/research/latest-guide-to-chinese-medical-device-gmp-regulations
However,
since October 2014, Chinese regulatory authorities have significantly changed
the regulations on medical devices. China Food and Drug Administration (CFDA)
issued the latest Chinese Good Manufacturing Practice (GMP) Regulations 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 Sterile Medical Devices, Implementation Regulations of Good
Manufacturing Practice (GMP) for Implantable Medical Devices as the appendices
of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical
Devices respectively. They have come into force as October 1, 2015.
Furthermore, on September 25, 2015, China Food and Drug Administration (CFDA)
issued the latest On-site Inspection Guideline of Good Manufacturing Practice
(GMP) for Medical Devices, On-site Inspection Guideline for Sterile Medical
Device GMP Implementation Regulations, and On-site Inspection Guideline for
Implantable Medical Device GMP Implementation Regulations. Everything changed.
No comments:
Post a Comment