Synopsis
Guide
to Prepare Application Dossiers for Oversea Medical device registration and
recordation in China not only provided a comprehensive and thorough knowledge
of the overall new requirements of application dossiers for medical device
registration or recordation in China but also provided the guidance of
practical operation for how to achieve a successful approval for your products
entry into the Chinese medical device market.
Summary
The
Chinese medical device market is one of segment market of the most growth
potentiality, which is attracting more and more overseas medical device
manufacturers and producers to penetrate such market. It is estimated that
Chinese medical device market will be likely to be more than 340 billion RMB
(about 57 billion US dollars) by 2015, and will surpass Japan to become the
second largest medical device market behind the United States.
View Full Report with TOC @ http://www.radiantinsights.com/research/guide-to-prepare-application-dossiers-for-oversea-medical-device-registration-and-recordation-in-china
However,
China’s regulatory framework for medical devices is undergoing radical changes.
China’s new leaders have recognized that the regulations for supervision and
administration of medical devices are far from perfect along with rapid
population growth and thriving economy over the past 30 years. Chinese state
council issued the latest “Regulations for the Supervision and Administration
of Medical Devices” on February 12, 2014, and it has come into force as of June
1, 2014. China Food and Drug Administration issued the latest “Measures for the
Administration of Medical Device Registration”, and it has come into force as
of October 1, 2014. The overseas medical devices exporting into China market
should be subject to administration of overall new regulations since October 1,
2014.
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Insights: http://www.radiantinsights.com/catalog/medical-devices
The
Chinese administration system for medical device registration undergone
significant changes. Chinese authorities have begun to strengthen the
supervision and administration of its medical device market. To strictly
examine and approve the application dossiers for oversea medical device
registration in China has become as the key threshold of oversea medical device
exporting into China. The Chinese approach to administer medical device
registration is unique. The application and approval process, clinical
evaluation and clinical trial, the requirements for application dossiers are
distinct from in U.S. and EU countries.How do you in compliance with the latest
Chinese regulations on medical devices? How do you operate business smoothly in
China? How to seize a bigger Chinese medical device market? The preparation of
application dossiers compliance with overall new regulations becomes as the key
for oversea medical device entry into Chinese medical device market.
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The
overseas and multinational medical device manufacturers must have a
comprehensive and thorough knowledge of the latest Chinese regulations on
medical device registration. Otherwise, the restrictive legal requirements and
approval delays 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.
Guide
to Prepare Application Dossiers for Oversea Medical device registration and
recordation in China not only provided a
comprehensive and thorough knowledge of the overall new requirements of
application dossiers for medical device registration or recordation in China
but also provided the guidance of practical operation for how to achieve a
successful approval for your products entry into the Chinese medical device
market.
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