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.
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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.
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China
Food and Drug Administration (CFDA) requests that all the newly established
medical device manufacturers, the existing medical device manufacturers to
increase production of Class III medical devices, the relocated medical device
manufacturers or the medical device manufacturers to expand manufacturing sites
should follow the requirements of the latest Good Manufacturing Practice (GMP)
Regulations for Medical Devices and the relevant assorted GMP implementation
regulations. Since January 1, 2016, the medical devices manufacturers to
manufacture Class III medical devices must comply with the the requirements of
the latest Good Manufacturing Practice (GMP) Regulations for Medical Devices
and the relevant assorted GMP implementation regulations. Since January 1,
2018, all the medical devices manufacturers must comply with the requirements
of the latest Good Manufacturing Practice (GMP) Regulations for Medical Devices
and the relevant assorted GMP implementation regulations.Those manufacturers
that do not meet those deadlines may face enforcement actions by the food and
drug regulatory authorities.
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At
present, overseas and multinational medical device manufacturers, as well as
domestic medical device manufacturers are confronting with multiple inspection
and verification of GMP rules and the relevant assorted GMP implementation
regulations. The overseas medical device manufacturers exporting Class II and
Class III overseas medical devices into Chinese medical device 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 medical device manufacturers have penetrated
into the Chinese medical device 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, 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”, etc.). 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 medical device 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 medical device manufacturing enterprise is compliance with
the GMP rules and the relevant assorted GMP implementation regulations.
How
do you in compliance with the latest Chinese medical device GMP regulations?
How do you operate business smoothly in China? The overseas and multinational
medical device manufacturers and their senior executive officers engaging in
regulatory affairs must have a comprehensive and thorough knowledge of the
latest Chinese medical device 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 medical device market, and cause trouble
for your business smoothly in China.
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