China’s regulatory framework for
in-vitro diagnostic reagents is undergoing earthshaking changes. The country’s
new leaders have recognized that the regulations for supervision and
administration of in-vitro diagnostic reagents 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 June 1, 2014. Before long, China Food and Drug Administration issued a
series of the latest regulations on in-vitro diagnostic reagents on July 30,
2014 respectively, and they will come into force as October 1, 2014. The
overseas in-vitro diagnostic reagents exporting into China market will be
subject to administration of overall new regulations on in-vitro diagnostic
reagent registration since October 1, 2014.
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,
in-vitro diagnostic reagents represented dynamical growth since 2007. By 2013,
total value of in-vitro diagnostic reagents on Chinese healthcare market has
reached 3.5 billion US dollars, an increase of 22.9% over 2012 level. It is
estimated that Chinese in-vitro diagnostic reagent market is likely to be more
than 5.5 billion US dollars until 2015, and it is one of segment market of the
most growth potentiality. The Chinese in-vitro diagnostic reagent market is
attracting more and more in-vitro diagnostic reagents produced by overseas and
multinational manufacturers to penetrate such market.
However, China’s radical change of
regulatory framework for in-vitro diagnostic reagents will bring overseas and
multinational in-vitro diagnostic reagent manufacturers the maximum challenges
and opportunities. How do you in compliance with the latest Chinese regulations
on in-vitro diagnostic reagents? How do you operate business smoothly in China?
To enter such a lucrative in-vitro diagnostic reagent market, overseas and
multinational in-vitro diagnostic reagent manufacturers must have a
comprehensive and thorough knowledge of the latest Chinese regulations on
in-vitro diagnostic reagent registration. Otherwise, the restrictive legal
requirements and approval delays eat up your time and energy to achieve a
successful entry into such a lucrative in-vitro diagnostic reagent market, and
cause trouble for your business smoothly in China.
Latest Chinese Guidebook for Application
and Approval of Imported In-vitro Diagnostic Reagent Registration: From
Regulations to Practices (2014 Edition) not only provided a comprehensive and
thorough knowledge of the latest Chinese regulations for imported in-vitro
diagnostic reagent registration but also introduced the practical operation how
to comply with the Chinese regulations to guide you achieve a successful
approval for your products entry into the Chinese in-vitro diagnostic reagent
market.
Report
Highlights
- An analysis and research for radical change of Chinese regulations on in-vitro diagnostic reagents.
- An overview of the latest Chinese applicable regulations for for in-vitro diagnostic reagent registration.
- An overview of organizational structure of Chinese regulatory authorities for imported overseas in-vitro diagnostic reagent registration and recordation to give the direction of gateway for imported overseas in-vitro diagnostic reagent registration.
- The Chinese general regulations for imported overseas in-vitro diagnostic reagent registration to let overseas in-vitro diagnostic reagent manufacturer understand the unique Chinese approach for in-vitro diagnostic reagent registration and lay the knowledge foundation for the practical operation.
- The detailed Chinese classification and naming principles for in-vitro diagnostic reagents.
- The Chinese unique requirements for clinical trials of in-vitro diagnostic reagents, from the basic principles of clinical trials, the clinical trial design, scheme and methods, the sample size of clinical trial, to the clinical trial report and protocol.
- The requirements for compilation of instruction of in--vitro diagnostic reagent registration in China.
- The practical guidance for application of imported overseas in-vitro diagnostic reagent recordation, from how to compile recordation documents, how to apply for recordation to how to handle alteration recordation to smoothly navigate complex regulatory requirements step by step.
- The practical guidance for application and approval of imported overseas in-vitro diagnostic reagent registration, also from how to compile application documents, how to compile the product technical requirements, how to apply for approval of imported overseas in-vitro diagnostic reagent registration to how to submit application documents to smoothly navigate complex regulatory requirements step by step.
The practical guidance for alteration
registration and renewal registration of imported overseas in-vitro diagnostic
reagents, also from how to compile application documents to how to submit
application documents step by step.
A complete set of full text in English
of the latest Chinese regulations for imported overseas in-vitro diagnostic
reagent registration, which cover
“Regulations for the Supervision and Administration of Medical Devices”,
“Measures for the Administration of In Vitro Diagnostic Reagent Registration”,
“Rules for Medical Device Classification”, “Technical Guidance Principles for
Clinical Trials of In--vitro Diagnostic Reagents” and “Guidance Principles for
Compilation of Instruction of In--vitro Diagnostic Reagents ”.
The audiences of this guidebook are
overseas in-vitro diagnostic reagent manufacturers wishing to enter into the
Chinese in-vitro diagnostic reagent market, and multinational in-vitro
diagnostic reagent companies have penetrated into the Chinese in-vitro
diagnostic reagent market, and their senior executive officers engaging in
regulatory affairs expecting to understand how to apply for registration of
their in-vitro diagnostic reagent products in China, how to comply with the
latest Chinese regulations for in-vitro diagnostic reagent registration. After
having skimmed through this guidebook, audiences can clearly acquire not only a
comprehensive and thorough knowledge of the latest Chinese regulations on
imported in-vitro diagnostic reagent registration but also the practical
operation how to comply with the latest Chinese regulations. Access China
Management Consulting Ltd hopes this guidebook, based on full and accurate
regulations, can guide overseas and multinational in-vitro diagnostic reagent
manufacturers and producers to achieve a successful entry into the Chinese
medical device market, and smoothly operate their products in China.
Scope
of the report
Latest Chinese Guidebook for Application
and Approval of Imported In-vitro Diagnostic Reagent Registration: From
Regulations to Practices (2014 Edition) not only provided a comprehensive and
thorough knowledge of the latest Chinese regulations for imported in-vitro
diagnostic reagent registration but also introduced the practical operation how
to comply with the Chinese regulations to guide you achieve a successful
approval for your products entry into the Chinese in-vitro diagnostic reagent
market.
Chapter 2 : provides the analysis and
research for radical change of Chinese regulations on in-vitro diagnostic
reagents.
Chapter 3: introduces the framework of
the latest Chinese applicable regulations for in-vitro diagnostic reagent
registration to provide a comprehensive and thorough knowledge of the latest
Chinese regulations for in-vitro diagnostic reagent registration.
Chapter 4: provides an overview of the
Chinese regulatory authorities -- China Food and Drug Administration (CFDA)
being responsible for approval for imported overseas in-vitro diagnostic
reagent registration and recordation to give the direction of gateway for
imported overseas in-vitro diagnostic reagent registration and recordation.
Chapter 5: elaborates the general
regulations for imported overseas in-vitro diagnostic reagent registration to
let overseas in-vitro diagnostic reagent manufacturer understand the unique
Chinese approach for in-vitro diagnostic reagent registration and lay the
knowledge foundation for the practical operation.
Chapter 6: elaborates the classification
and naming principles for in-vitro diagnostic reagents to let overseas in-vitro
diagnostic reagent manufacturer understand the Chinese in-vitro diagnostic
reagent classification and nomenclature, because the imported overseas in-vitro
diagnostic reagent registration must be in compliance with such classification
and nomenclature of in-vitro diagnostic reagents.
Chapter 7: introduces the Chinese unique
requirements for clinical trials of in-vitro diagnostic reagents, from the
basic principles of clinical trials, the clinical trial design, scheme and
methods, the sample size of clinical trial, to the clinical trial report and
protocol step by step.
Chapter 8: introduces the requirements
for compilation of instruction of in--vitro diagnostic reagent registration.
Chapter 9: introduces the regulations
for application for imported in-vitro diagnostic reagent recordation, which is
applicable to Class I imported overseas in-vitro diagnostic reagents.
Chapter 10: provides the regulations for
application and approval for imported in-vitro diagnostic reagent registration,
which is applicable to Class II and III imported overseas in-vitro diagnostic
reagents.
Chapter 11: introduces the regulations
for application and approval for alteration registration of imported overseas
in-vitro diagnostic reagents.
Chapter 12: introduces the regulations
for renewal registration of imported overseas in-vitro diagnostic reagents.
Chapter 13: introduces the regulations
for supervision and administration for application and approval of imported
overseas in-vitro diagnostic reagent registration and recordation.
Chapter 14: provides the practical
guidance for application of imported overseas in-vitro diagnostic reagent
recordation, from how to compile recordation documents, how to apply for
recordation to how to handle alteration recordation to smoothly navigate
complex regulatory requirements step by step.
Chapter 15: provides the practical
guidance for application and approval of imported overseas in-vitro diagnostic
reagent registration, also from how to compile application documents, how to
compile the product technical requirements, how to apply for approval of
imported overseas in-vitro diagnostic reagent registration to how to submit
application documents to smoothly navigate complex regulatory requirements step
by step.
Chapter 16: provides the practical
guidance for alteration registration and renewal registration of imported overseas
in-vitro diagnostic reagents, also from how to compile application documents to
how to submit application documents step by step.
Chapter 17: Appendices provide a
complete set of full text in English of the latest Chinese regulations for
imported overseas in-vitro diagnostic reagent registration.
Spanning
over 208 pages, “Latest Chinese
Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent
Registration: From Regulations to Practices (2014 Edition)” report covering
the Executive Summary, Analysis and Research for Radical Change of Chinese
Regulations on In Vitro Diagnostic Reagents, Latest Chinese Applicable
Regulations for In-vitro Diagnostic Reagent Registration, An Overview of
Chinese Regulatory Authorities for Imported In-vitro Diagnostic Reagent
Registration, General Regulations for Imported In-vitro Diagnostic Reagent
Registration, Classification and Naming Principles for In-vitro Diagnostic
Reagents, Clinical Trials of In-vitro Diagnostic Reagents, Compilation of
Instruction of In--vitro Diagnostic Reagent Registration, Application for
Imported In--vitro Diagnostic Reagent Recordation, Application and Approval for
Imported In--vitro Diagnostic Reagent Registration, Application and Approval
for Alteration Registration of Imported In-vitro Diagnostic Reagents,
Application and Approval for Renewal Registration of Imported In-vitro
Diagnostic Reagents, Supervision and Administration for Application and
Approval of Imported In-vitro Diagnostic Reagent Registration and Recordation,
Guidance for Application of Imported In-vitro Diagnostic Reagent Recordation,
Practical Guidance for Application and Approval of Imported In-vitro Diagnostic
Reagent Registration, Practical Guidance for Alteration Registration and
Renewal Registration of Imported In vitro Diagnostic Reagent, Appendices. The
report covered 5 compnies - Life Technologies, Roche,Abbott, Siemens, Beja
Asian capital
Know more about this report
at
– http://mrr.cm/ZaM
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