China’s
regulatory framework for medical devices is undergoing radical changes. The
country’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, which has come into force as of June
1, 2014. Before long, China Food and Drug Administration (hereafter called as
CFDA) issued the latest “Measures for the Administration of Medical Device
Registration”, which has come into force as of October 1, 2014.The overseas
medical devices exporting into China market are subject to administration of
overall new regulations on medical device registration since October 1, 2014.
In
2009, the Chinese government vigorously launched “China’s Health-Care Reform”,
developed an ambitious blueprint, in which health care system covered about 1.2
billion people by 2011. 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 2013, total value of medical devices on Chinese healthcare market has
reached 179 billion RMB (about 29 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 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, CT 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 57 billion US dollars) by 2015, and will surpass Japan to become the
second largest medical device market behind the United States. 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.
China’s
radical change of regulatory framework for medical devices brings overseas and
multinational medical device manufacturers the maximum challenges and
opportunities. Those overseas medical devices have not been granted the
certificate of marketing authorization of medical device issued by the government
authorities of the country or region of origin have been intercepted outside
the door of Chinese clinical trial market not only, and be blocked outside the
door of Chinese medical device market also. Nonetheless, Chinese authorities
relaxed the admittance license of overseas medical devices. The overseas
medical device manufacturer exporting Class I medical devices into China only
need to file the archives and the certificate of marketing authorization of the
government authorities of the country or region of origin to the CFDA for
recordation. The overseas medical device manufacturer exporting Class II and
Class III medical devices into China should be subject to be examined and
approved by the CFDA. The Chinese authorities will strengthen the supervision
and administration for medical devices, including their registration,
production, distribution and use. How do you in compliance with the latest
Chinese regulations on medical devices? How do you operate business smoothly in
China? How do you conduct the clinical evaluation and clinical trial for your
products exporting into the Chinese market?
The
Chinese concept of clinical evaluation and clinical trial for medical device
registration is unique, which is distinct from the clinical trial in U.S. and
EU countries.
In
China, the process of application and approval for clinical evaluation and
clinical trial of imported medical device registration is very complex, because
the Chinese medical device authorities administer and control this process by
exorbitant administrative measures and regulations, even the guidances.
Moreover, these exorbitant administrative measures and regulations, and the
guidances are variable and lack of transparency. In addition, the cultural
difference between China and Western countries as well as the language barriers
will increase the challenge faced by overseas and multinational medical device
manufacturers and producers.
To
enter such a lucrative medical device market, overseas and multinational
medical device manufacturers must have a comprehensive and thorough knowledge
of the latest Chinese regulations on medical device clinical evaluation and
clinical trial. Otherwise, the restrictive legal requirements and approval
delays eat up your development time and budget.
Scope of the report:
Latest
Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial
in China: From Regulations to Practices (2014 Edition) not only provided a
comprehensive and thorough knowledge of the latest Chinese regulations on
clinical evaluation and clinical trial for imported medical device registration
but also introduced the practical operation how to comply with the Chinese GCP
to guide you use the Chinese trial venues to keep medical device development
lean and achieve a successful approval for your products entry into the Chinese
medical device market.
The organizations of this
guidebook are arranged as follows.
Chapter
2 introduces the framework of the latest Chinese applicable regulations for
clinical evaluation and clinical trial of medical device registration to
provide a comprehensive and thorough knowledge of the latest Chinese
regulations for clinical evaluation and clinical trial of medical device
registration.
Chapter
3 provides a comprehensive comparative analysis to tell overseas medical device
manufacturer what Chinese regulations on medical device registration are
undergoing radical changes, from what Chinese regulations on imported medical
device registration are undergoing radical changes to what overseas medical
devices need to conduct the clinical evaluation or clinical trial for imported
medical device registration.
Chapter
4 provides an overview of the Chinese regulatory authorities -- China Food and
Drug Administration (CFDA) being responsible for application and approval for
clinical evaluation and clinical trial of imported medical device registration
to give the direction of gateway for application for approval of clinical trial
of imported overseas medical device registration.
Chapter
5 elaborates the knowledge preparation before consucting the clinical
evaluation and clinical trial for imported medical device registration to let
overseas medical device manufacturer understand the unique Chinese approach for
medical device registration and lay the knowledge foundation for the practical
operation.
Chapter
6 elaborates the medical device classification to let overseas medical device
manufacturer understand the Chinese medical device classification, because the
imported overseas medical device registration must be in compliance with such
classification of medical devices.
Chapter
7 introduces the rights of human subjects and every party’s responsibilities in
clinical trials for imported overseas medical devices in China.
Chapter
8 introduces the unique Chinese regulations for clinical evaluation and
clinical trial of imported medical device registration to help overseas medical
device manufacturers to remove their confusion.
Chapter
9 provides the practical guidance for applying for clinical trials of imported
overseas medical device registration, from what imported overseas medical
devices need to conduct clinical trial and approval within chinese territory,
how to apply for clinical trial of imported overseas medical device
registration, how to compile the product technical requirements, how to compile
application documents to how to acquire the approval document for clinical
trial of imported overseas medical device registration to smoothly navigate
complex regulatory requirements step by step.
Chapter
10 provides the practical guidance for conducting clinical evaluation of
imported overseas medical device registration, also from what imported overseas
medical devices need to conduct clinical evaluation of imported overseas
medical device registration, what requirements are for conducting clinical
evaluation of imported overseas medical device registration, how to conduct the
clinical evaluation of imported overseas medical device registration to how to
compile application documents to smoothly navigate complex regulatory
requirements step by step.
Chapter
11 Appendices provide a complete set of full text in English of the latest
Chinese applicable regulations for medical device clinical evaluation and
clinical trial of imported overseas medical device registration, which include
“Regulations for the Supervision and Administration of Medical Devices (2014
Edition)”, “Measures for the Administration of Medical Device Registration
(2014 Edition)”, “Regulations on the Administration of the Instructions and
Labels of Medical Devices (2014 Edition)”, “Rules for Medical Device
Classification (2014 Edition)” , “Provisions for Clinical Trials of Medical
Devices” and “Technical Guidance Principles for Clinical Evaluation of Medical
Devices”.
The
audiences of this guidebook are overseas medical device manufacturers wishing
to enter into the Chinese medical device market, and multinational medical
device companies have penetrated into the Chinese medical device market, and
their senior executive officers engaging in regulatory affairs expecting to
understand how to smoothly conduct clinical evaluation and clinical trial for
their medical device product registration in China, and how to comply with the
Chinese GCP.
After
having skimmed through this guidebook, audiences can clearly acquire not only a
comprehensive and thorough knowledge of latest Chinese regulations on clinical
evaluation and clinical trial for imported overseas medical device registration
but also the practical operation how to comply with the Chinese GCP, how to
conduct the clinical evaluation and clinical trial for imported overseas
medical device registration. Access China Management Consulting Ltd hopes this
guidebook, based on full and accurate laws and regulations, can guide overseas and
multinational medical device manufacturers and producers to achieve a
successful entry into the Chinese medical device market, and smoothly operate
the clinical evaluation and the clinical trial for their products in China.
Report Highlights:
- An overview of the latest Chinese applicable regulations for clinical
evaluation and clinical trial of medical device registration.
- A comprehensive comparative analysis ---- what Chinese regulations on medical
device registration are undergoing radical changes.
- An overview of organizational structure of Chinese regulatory authorities for
clinical evaluation and clinical trial of imported overseas medical devices
registration to give the direction of gateway for application for approval of
clinical trial for imported overseas medical device registration.
- The knowledge preparation before consucting the clinical evaluation and
clinical trial for imported overseas medical device registration to let
overseas medical device manufacturer understand the unique Chinese approach for
medical device registration and lay the knowledge foundation for the practical
operation.
- The detailed Chinese classification for medical devices.
- The rights of human subjects and every party’s responsibilities in clinical
trials for imported overseas medical device registration in China.
- The unique Chinese regulations for clinical evaluation and clinical trial of
imported overseas medical device registration to help overseas medical device
manufacturers to remove their confusion.
- The practical guidance for applying for clinical trials of imported overseas
medical device registration, from what imported overseas medical devices need
to conduct clinical trial and approval within Chinese territory, how to apply
for clinical trial of imported overseas medical device registration, how to
compile the product technical requirements, how to compile application
documents to how to acquire the approval document for clinical trial of
imported overseas medical device registration to smoothly navigate complex
regulatory requirements step by step.
- The practical guidance for conducting clinical evaluation of imported overseas
medical device registration, also from what imported overseas medical devices
need to conduct clinical evaluation of imported overseas medical device
registration, what requirements are for conducting clinical evaluation of
imported overseas medical device registration, how to conduct the clinical evaluation
of imported overseas medical device registration to how to compile application
documents to smoothly navigate complex regulatory requirements step by step.
- A complete set of full text in English of the latest Chinese applicable
regulations for medical device clinical evaluation and clinical trial of
imported overseas medical device registration, which include “Regulations for
the Supervision and Administration of Medical Devices (2014 Edition)”,
“Measures for the Administration of Medical Device Registration (2014
Edition)”, “Regulations on the Administration of the Instructions and Labels of
Medical Devices (2014 Edition)”, “Rules for Medical Device Classification (2014
Edition)” , “Provisions for Clinical Trials of Medical Devices” and “Technical Guidance
Principles for Clinical Evaluation of Medical Devices”.
Reasons to Buy:
China’s
regulatory framework for medical devices is undergoing radical changes. The
country’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, which has come into force as of June
1, 2014. Before long, China Food and Drug Administration (hereafter called as
CFDA) issued the latest “Measures for the Administration of Medical Device
Registration”, which has come into force as of October 1, 2014.The overseas
medical devices exporting into China market are subject to administration of
overall new regulations on medical device registration since October 1, 2014.
The
Chinese concept of clinical evaluation and clinical trial for medical device
registration is unique, which is distinct from the clinical trial 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 do you
conduct the clinical evaluation and clinical trial for your products exporting
into the Chinese market?
To
enter such a lucrative medical device market, overseas and multinational
medical device manufacturers must have a comprehensive and thorough knowledge
of the latest Chinese regulations on medical device clinical evaluation and
clinical trial. Otherwise, the restrictive legal requirements and approval
delays eat up your development time and budget.
Latest
Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial
in China: From Regulations to Practices (2014 Edition) not only provided a
comprehensive and thorough knowledge of the latest Chinese regulations on
clinical evaluation and clinical trial for imported medical device registration
but also introduced the practical operation how to comply with the Chinese GCP
to guide you use the Chinese trial venues to keep medical device development
lean and achieve a successful approval for your products entry into the Chinese
medical device market.
The
overseas medical device manufacturers wishing to enter into the Chinese medical
device market, the multinational medical device manufacturers have penetrated
into the Chinese medical device market, and their senior executive officers
engaging in regulatory affairs for clinical evaluation and clinical trial of
exporting overseas medical device into Chinese lucrative medical device market,
senior executive officers engaging in applying for approval of exporting
overseas medical device registration in China need to understand these latest
Chinese registrations and the practical operation. Otherwise, the restrictive
legal requirements and approval delays eat up your development time and budget,
and cause trouble for your business smoothly in China.
