Monday 30 November 2015

Market Research Report On Full text of “Global Industrial Chocolate" 2015 By Hexa Reports Inc.


Industrial chocolate is produced primarily from cocoa liquor/paste and butter, which are combined with other ingredients such as sugar and powdered milk, then refined and conched. The formulations, however, vary depending on their application. It is essentially used in-house by vertically integrated manufacturers or sold to third parties, to create finished chocolate products. The primary consumers are food service providers such as chefs and artisans and food manufacturers who create end-consumer products such as chocolate confectionary, bakery products, ice-cream, and beverages.


Covered in this report
In this report, Technavio covers the present scenario and growth prospects of the global industrial chocolate market for the period 2015-2019. To calculate the market size, we consider revenue generated from the sale of industrial chocolate worldwide.

Table Of Content

PART 01: Executive summary
 Highlights
PART 02: Scope of  the report
 Market overview
 Top-vendor offerings
PART 03: Market research methodology
 Research methodology
 Economic indicators

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PART 04: Introduction
 Key market highlights
PART 05: Chocolate market: An overview
 Cocoa: An overview
 Global chocolate market: An overview
 Evolution of industrial chocolate market
PART 06: Market landscape
 Market overview
 Market size and forecast
 Five forces analysis
PART 07: Segmentation  by market entity
 Global industrial chocolate market by market entity
PART 08: Geographical segmentation
 Global industrial chocolate market by geography
 Industrial chocolate market in Europe
 Industrial chocolate market in the Americas
 Industrial chocolate market in APAC
 Industrial chocolate market in MEA
PART 09: Market drivers
 Consistent demand for chocolates
 Wide scope of applications
 Rising investments in cocoa production
 Increasing demand from developing countries
PART 10: Impact of drivers
PART 11: Market challenges
 Rising cocoa prices
 High entry barriers
 Increased concentration across the supply chain
 Demand outstripping supply of cocoa beans
PART 12: Impact of drivers and challenges
PART 13: Market trends
 Innovations
 Nutrition enhancement
 Growing importance of Fairtrade products
 Transparency in ingredient labeling
PART 14: Regulatory bodies and trade associations
 International Cocoa Organization (ICCO)
 World Cocoa Foundation
 International Cocoa Farmers Organization (ICCFO)
 Fair Trade Cocoa Corporation
PART 15: Vendor landscape
 Competitive scenario
 Market share analysis 2014
 Other prominent vendors


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Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.
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Hexa Reports - Global Industrial Automation Industry in Food and Beverage Market in Food and Beverage Industry Report Review


Industries worldwide are opting for efficient manufacturing processes that improve productivity and reduce total cost of ownership. Industrial automation solutions aid end-users in organizing their manufacturing processes efficiently and providing real-time information about each sub-system of the plant. They enhance the quality of products and help them innovate to gain a competitive edge.

The demand for a high degree of consistency in quality of food and beverages is prompting the F&B industry to improve their production processes. The F&B industry is required to maintain critical control points, identified as HACCP, to meet safety standards of food safety authorities.


Covered in this report
This report covers the present scenario and growth prospects of the global industrial automation market in the F&B industry for the period 2015-2019. To calculate the market size, the report considers revenue generated from sales of industrial automation products such as DCS, PLC, SCADA, and MES in the F&B industry.

Table Of Content

PART 01: Executive summary
 Highlights
PART 02: Scope of the report
 Market overview
 Top-vendor offerings
PART 03: Market research methodology
 Research methodology
 Economic indicators

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PART 04: Introduction
 Key market highlights
PART 05: Market landscape
 Market overview
 Market size and forecast
 Five forces analysis
PART 06: Market segmentation by product
 Market overview
 Global DCS market in F&B industry
 Global PLC market in F&B industry
 Global SCADA market in F&B industry
 Global MES market in F&B industry
PART 07: Geographical segmentation
 Industrial automation market in F&B industry in EMEA
 Industrial automation market in F&B industry in Americas
 Industrial automation market in F&B industry in APAC
PART 08: Market drivers
PART 09: Impact of drivers
PART 10: Market challenges
PART 11: Impact of drivers and challenges
PART 12: Market trends
PART 13: Vendor landscape
 Competitive scenario
 Other prominent vendors
PART 14: Key vendor analysis
 ABB
 Siemens
 Honeywell International
 Yokogawa Electric
 Schneider Electric
PART 15: Appendix
 List of abbreviations


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.
Contact Information:

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New market study, “Global HER2-Negative Breast Cancer", has been published By Hexa Reports



HER2-negative breast cancer is a subtype of breast cancer and is the condition when the HER2 is expressed less in the tumor. According to the American Society of Clinical Oncology, most of the patients with breast cancer are known to have HER2-negative breast cancer. HER2-negative breast cancer patients can also be hormone receptor positive (HR+). The HER2 protein is found on the outer surface of the breast cells, and the hormone receptors are found inside breast cells. The cancers that have detectable hormone receptors are known as HR+ breast cancer, and those with HER2-negative have a low level of HER2 gene or the HER2 protein. HER2-negative breast cancer can also be HR+ and then the most preferred therapy is hormone therapy. These patients can be treated with chemotherapy or targeted therapy to improve their condition.


Covered in this report
This report covers the present scenario and the growth prospects of the global HER2-negative breast cancer market for the period 2015-2019. To calculate the market size, the report considers revenue generated from the sales of various off-label and branded drugs and the expected launch of drug candidates intended to be used in the treatment of HER2-negative breast cancer.

Table Of Content

PART 01: Executive summary
 Highlights
PART 02: Scope of the report
 Market overview
 Top vendor offerings
PART 03: Market research methodology
 Research methodology
 Economic indicators

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PART 04: Introduction
 Key market highlights
PART 05: Market landscape
 Market overview
 Market size and forecast
 Five forces analysis
PART 06: Market segmentation  by type of drug molecule
 Biologics
 Small molecules
PART 07: Market segmentation by route of administration
 Oral
 Parenteral
PART 08: Geographical segmentation
 Market segmentation by geography 2014-2019
 HER2-negative breast cancer market in Americas 2014-2019
 HER2-negative breast cancer market in EMEA 2014-2019
 HER2-negative breast cancer market in APAC 2014-2019
PART 09: Pipeline portfolio
 Key information about late-stage pipeline candidates
PART 10: Market drivers
PART 11: Impact of drivers
PART 12: Market challenges
PART 13: Impact of drivers and challenges
PART 14: Market trends
PART 15: Vendor landscape
 Competitive scenario
 Key news


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.
Contact Information:

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Felton Office Plaza,
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Felton, California, 95018,
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Phone Number
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Global Hemophilia B Industry Forecast and Overview 2015 - 2019


Hemophilia B, also called the Christmas disease, is a blood coagulation disorder due to the deficiency or improper function of factor IX. It is inherited in an X-linked recessive pattern. This disorder is more prevalent in males than in females. Factor replacement therapies, mainly recombinant, are used in the treatment.


Covered in this report
The report includes the present scenario and the growth prospects of the global hemophilia B market for 2015-2019. To calculate the market size, the report considers revenue generated from the sales of various drugs used in the treatment of hemophilia B.

Table Of Content

PART 01: Executive summary
 Highlights
PART 02: Scope of the report
 Market overview
 Top-vendor offerings
PART 03: Market research methodology
 Research methodology
Economic indicators

Request A Sample copy of This Report @ http://www.hexareports.com/sample/50090

PART 04: Introduction
 Key market highlights
PART 05: Market landscape
 Market overview
 Market size and forecast
 Five forces analysis
PART 06: Disease overview
 Understanding the disease
 Epidemiology
PART 07: Pipeline portfolio
 Key information of few pipeline candidates
PART 08: Market segmentation by disease severity
 Mild hemophilia B
 Moderate hemophilia B
 Severe hemophilia B
PART 09: Market segmentation by disease management
 On-demand therapy
 Prophylactic therapy
 Inhibitor therapy
PART 10: Geographical segmentation
PART 11: Market drivers
 Focus on prophylactic treatment
 Drugs with prolonged action
 Patient assistance programs
PART 12: Impact of drivers
PART 13: Market challenges
 High cost of therapy
 Low diagnosis rate in developing countries
 Complications of available therapies
PART 14: Impact of drivers and challenges
PART 15: Market trends
 Advances in technology
 Strategic alliances
 Development of gene therapy products


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.

Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
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Global Hemophilia A Market Size and Share, Growth, Market Price, Analysis, Forecast and Overview 2015 - 2019



Hemophilia is a rare bleeding disorder caused by deficiency of clotting factors such as VIII and IX. It is an X-linked recessive disorder, which is more prevalent in males than in females. It is estimated that it affects around 400,000 people per year. The two major types of hemophilia are A and B. Hemophilia A, also called as classical hemophilia or factor VIII deficiency hemophilia, is caused by deficiency of clotting factor VIII. It is transmitted genetically from parent to child during birth. Recombinant clotting factors or plasma-derived clotting factors are being developed for the treatment of this disorder.


Covered in this report
The report covers the current scenario and the growth prospects of the global hemophilia A drugs market for the period of 2015-2019. To calculate the market size, the report considers revenue generated from the sales of various drugs used in the treatment and prevention of hemophilia A. In this report, the market is also segmented based on the type of therapy.


Table Of Content

PART 01: Executive summary
 Highlights
PART 02: Scope of  the report
 Market overview
 Top-vendor offerings
PART 03: Market research methodology
 Research methodology
 Economic indicators

Request A Sample copy of This Report @ http://www.hexareports.com/sample/50089

PART 04: Introduction
 Key market highlights
PART 05: Disease overview
 Understanding the disease
 Risk factors
 Signs and symptoms
 Diagnosis
 Treatment
 Epidemiology
PART 06: Pipeline portfolio
 Key information on pipeline candidates
PART 07: Market landscape
 Market overview
 Market size and forecast
 Five forces analysis
PART 08: Segmentation by type of therapy
 Plasma-derived therapies
 Recombinant therapies
PART 09: Segmentation by disease management
 On-demand therapy
 Prophylaxis
 Inhibitors
PART 10: Geographical segmentation
PART 11: Market drivers
PART 12: Impact of drivers
PART 13: Market challenges
PART 14: Impact of drivers and challenges
PART 15: Market trends


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.

Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
1-800-489-3075

Monday 16 November 2015

Full text of “Chinese Drug Recall Regulations 2015" Research Report Review

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, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs on Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than RMB 1450 billion by 2015, and will surpass Japan to become the second largest drug market following the United States. The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market. 
 

Latest guidebook for Chinese Drug Recall Regulations (2014 Edition) is an essential resource for overseas and multinational pharmaceutical manufacturers and producers to handle a drug recall smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese drug recall regulations. 
 
Table Of Content 

Chapter 1 Introduction.2

Chapter 2  An Overview of Chinese Regulatory Authorities for Drug Recall.4

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Chapter 3 General Regulations for Drug Recall.6
3.1. Definitions.6
3.2. The special regulations for overseas manufacturers of imported drugs.6
3.3. Who, Where and How to Submit the Report relating to Drug Recall?.6
3.4. The Manufacturers Duty for Drug Recall.7
3.5. The Distributor and User Facilitys Duty for Drug Recall.8

Chapter 4 Voluntary Recall of Drugs.11
4.1. Regulations for Voluntary Recall of Drugs.11
4.2. An Entire Process of Voluntary Recall of Drugs.13

Chapter 5 Mandatory Recall of Drugs.16
5.1. Regulations for Mandatory Recall of Drugs.16
5.2. Entire Process of Mandatory Recall of Drugs.18

Chapter 6 Legal Liabilities.22

Chapter 7 Case Study
Agent (Xi'an-Janssen Pharmaceutical Ltd) Recall Imported Drug Caelyx and Velcade produced at Ben Venue Laboratories, U.S.A. 25


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.

Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
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Chinese Pharmaceutical GMP Regulations Industry product price, Size, profit, capacity, production, Industry growth rate etc.

Latest Guide to Chinese Pharmaceutical GMP Regulations provides a comprehensive and thorough knowledge of the Chinese pharmaceutical GMP regulations to guide overseas pharmaceutical companies and multinational pharmaceutical companies to achieve a successful entry into the Chinese lucrative drug market and help overseas pharmaceutical companies and multinational pharmaceutical companies to make decisions on entry into the Chinese lucrative drug market.

 

Summary

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.


Table Of Content 
Chapter 1 Introduction.. 5

Chapter 2 An Overview of Good Manufacturing Practice (GMP) for Drugs..11
2.1. General..11
2.2. Glossary 11
2.3. Quality Management..16
2.4. Organization and Personnel...19
2.5. Premises and Facilities..25

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Chapter 3 Good Manufacturing Practice for Sterile Pharmaceutical Products.. 75
3.1. Scope of Application. 75
3.2. Glossary.. 75
3.3. Principles. 76
3.4. Cleanliness Levels and Monitoring.. 77
3.5. Operation Techniques for Isolation.. 81

Chapter 4 Good Manufacturing Practices for Active Pharmaceutical Ingredients. 96
4.1. Applicable Scope.. 96
4.2. Glossary.. 96
4.3. Buildings and facilities . 97
4.4. Equipments 97
4.5. Materials.. 98

Chapter 5 Good Manufacturing Practice for Biological Products.. 112
5.1. Scope of Application..112
5.2. Glossary  .112
5.3. Principles. 112
5.4. Personnel 113
5.5. Premises and Equipments.114

Chapter 6 Good Manufacturing Practice for Blood Products 120
6.1. Applicable Scope..120
6.2. Principles. 120
6.3. Personnel 120
6.4. Premises and Equipments... 121
6.5. Raw Plasma.. 122

Chapter 7 Good Manufacturing Practice for Traditional Chinese Medicine Preparations. 126
7.1. Scope of Application 126
7.2. Glossary.. 126
7.3. Principles  ...126
7.4. Organization and Personnel... 126
7.5. Premises and Facilities .127


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.

Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
1-800-489-3075

Market Research Report On Full text of “Chinese Medical Device GMP Regulations" 2015 By Hexa Reports


Latest Guide to Chinese Medical Device GMP Regulations is an essential resource for overseas medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, which provides a detailed guidance of comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.
 

Summary

China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets around the world. 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 2012, total value of medical devices on Chinese healthcare market has reached 138 billion RMB.
 
                
Table Of Content 

Chapter 1  Introduction.4

Chapter 2 Chinese Regulatory Authorities for Medical Device GMP Regulations.8

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Chapter 3 An Overview of Good Manufacturing Practice (GMP) for Medical Devices.10
3.1. General Provisions.10
3.2. Glossary.10
3.3. Management Responsibilities.12
3.4. Management of Resources.12
3.5. Documents and Records.13

Chapter 4 Inspection of Good Manufacturing Practice (GMP) for Medical Devices.23
4.1. Regulatory Authorities for Medical Device GMP Inspection.23
4.2. Application and Material Review.23
4.3. On-site Inspection.25
4.4. Inspection Conclusion.27
4.5. Supervision for Inspection.28

Chapter 5 Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices.69
5.1. Implementation Guidelines of Good Manufacturing Practice (GMP) for Sterile Medical Devices.69
5.2. Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices.84
5.3. Appendix: Setting Principles of Sterile Medical Device Production Clean Room (Area).138

Chapter 6 Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices.141
6.1. Implementation Guidelines of Good Manufacturing Practice (GMP) for Implantable Medical Devices.141
6.2. Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices.160
6.3. Appendix: Setting Principles of Sterile Implantable Medical Device Production Clean Room (Area).211
                                   

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Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.


Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
1-800-489-3075

Hexa Reports - A Comprehensive Guidebook for Foreign Pharmaceutical Companies Industry Report Review


This is the first guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the latest Chinese regulations for imported drug registration, and guide overseas pharmaceutical manufacturers and producers to file the application for their imported drugs with the Chinese pharmaceutical authorities.


Summary
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.
Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door of a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities.

Table Of Content

Chapter 1. Introduction.5

Chapter 2. The State Food and Drug Administration in China.6
2.1. SFDAs Main Responsibilities.6
2.2. SFDAs Organizational Structure..7

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Chapter 3. General Regulations on Application and Approval for Imported Drug Registration.13
3.1. Classification of Drugs..13
3.2. Definitions.13
3.3. General Regulations on Application and Approval for Imported Drug Registration.17
3.3.1. Application and Approval for Imported Drugs.17
3.3.2. Application and Approval for Repackaging of Imported Drug.21
3.3.3. Supplementary Application..23
3.3.4. Re-registration..24
3.3.5. Clinical Trials.26
3.3.6. Time Limits in Drug Registration30

Chapter 4. Application and Approval Procedures for Imported Drug Registration..33
4.1. Application and Approval Procedure for Imported Drugs33
4.2.Supplementary Application and Approval Procedure for Imported Drugs..35
4.3.Application and Approval Procedure for Clinical Trials.37

Chapter 5. Application Form for Imported Drug Registration.39

Chapter 6. Conclusion..44

Chapter 7. Appendices46
7.1. The Drug Administration Law of the Peoples Republic of China..46
7.2. The Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China..71
7.3. The Good Clinical Practice of Pharmaceutical Products95
7.4. References.115
7.5. Companys Description116


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.
   
Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
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Research and Markets: Imported Medical Device Registration Industry Analysis 2015-2020


Now, Chinese regulations on medical devices are undergoing earthshaking changes. Latest Chinese Guidebook for Application and Approval of Imported Medical Device RegistrationFrom Regulations to Practices  not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device 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 medical device market.


Now, Chinese regulations on medical devices are undergoing earthshaking changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the pasted three decades. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices”  to try to completely change such imperfect status. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, “Regulations on the Administration of the Instructions and Labels of Medical Devices”, “Measures for the Supervision and Administration of Medical Device Production”, “Measures for the Supervision and Administration of Medical Device Distribution” and “Measures for the Administration of IVD registration” on July 30, 2014 respectively

Table Of Content

Chapter 1 Executive Summary.4

Chapter 2 Analysis and Research for Radical Change of Chinese Regulations on Medical Devices.8
2.1. What Chinese Regulations on Medical Devices are Undergoing Earthshaking Changes?.8
2.2. What is the Reason to Drive Chinese Regulations on Medical Devices Radical Change?.11

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Chapter 3 Chinese Applicable Regulations for Medical Device Registration.14

Chapter 4 An Overview of Chinese Regulatory Authorities for Imported Medical Device Registration.16
4.1. CFDAs Main Responsibilities.17
4.2. CFDAs Organizational Structure.19
4.3. Roadmap of Application and Approval for Imported Medical Device Registration.25

Chapter 5 Knowledge Preparation before Application of Imported Medical Device Registration.28
5.1. Definitions.28
5.2. Classified Administration for Registration and Recordation of Medical Devices.29
5.3. What Medical devices may be exported into China.30
5.4. Regulations on Applicant or Filer for Imported Medical Device Registration or Recordation.30
5.5. Product Technical Requirements.31
5.6. Registration Tests.32
5.7. Clinical Evaluation.33

Chapter 6 Medical Device Classification.36
6.1. Guidelines and Principles for Medical Device Classification.36
6.2. Judgment Table for Medical Device Classification.41

Chapter 7 Rights of Human Subjects and Every Party's Responsibilities in Clinical Trials for Imported Medical Devices.46
7.1. Rights and Interests of Human Subject.46
7.2. The Responsibilities for Implementer of Clinical Trials.47
7.3. The Responsibilities for Medical Institutions and Personnel of Clinical Trials.48


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.


Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
1-800-489-3075

New market study, “Imported In-vitro Diagnostic Reagent Registration", has been published By Hexa Reports


Chinas regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. It 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  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.
    
Table Of Content

Chapter 1 Executive Summary.5

Chapter 2 Analysis and Research for Radical Change of Chinese Regulations on In Vitro Diagnostic Reagents.9
2.1. What the Chinese regulations on in-vitro diagnostic reagents are undergoing earthshaking changes?.9
2.2. What is the reason to drive Chinese regulations on in-vitro diagnostic reagents radical change?.11

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Chapter 3 Latest Chinese Applicable Regulations for In-vitro Diagnostic Reagent Registration.14

Chapter 4 An Overview of Chinese Regulatory Authorities for Imported In-vitro Diagnostic Reagent Registration.17
4.1. CFDAs Main Responsibilities.17
4.2. CFDAs Organizational Structure.20

Chapter 5 General Regulations for Imported In-vitro Diagnostic Reagent Registration.28
5.1. Definitions.29
5.2. Classified Administration for Registration and Recordation of In-vitro Diagnostic Reagents.30
5.3. What in-vitro diagnostic reagents may be exported into China?31
5.4. Regulations on Applicant or Filer for Imported In-vitro Diagnostic Reagent Registration or Recordation.31
5.5. Product Technical Requirements.32

Chapter 6 Classification and Naming Principles for In-vitro Diagnostic Reagents.39
6.1. Classification for In-vitro Diagnostic Reagents.39
6.2. Naming Principles for In-vitro Diagnostic Reagents.46

Chapter 7 Clinical Trials of In-vitro Diagnostic Reagents.46
7.1. Basic Principles of Clinical Trials.47
7.2. Principles of Clinical Trial Design.49
7.3. Clinical Trial Report.54
7.4. Clinical Trial Protocol.57


About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.


Contact Information:

Ryan Shaw

Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
1-800-489-3075

Tuesday 10 November 2015

Latest Report On Global Wind Farm Operation Industry Research 2015


The Global Wind Farm Operation Industry 2015 Market Research Report is a professional and in-depth study on the current state of the Wind Farm Operation industry.

The report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure.The Wind Farm Operation market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.


Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

The report focuses on global major leading industry players providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis is also carried out.The Wind Farm Operation industry development trends and marketing channels are analyzed. Finally the feasibility of new investment projects are assessed and overall research conclusions offered.

Table Of Content

1 Industry Overview
1.1 Definition and Specifications of Wind Farm Operation
1.2 Classification of Wind Farm Operation
1.3 Applications of Wind Farm Operation
1.4 Industry Chain Structure of Wind Farm Operation
1.5 Industry Regional Overview of Wind Farm Operation

2 Manufacturing Cost Structure Analysis of Wind Farm Operation
2.1 Raw Material Suppliers and Price Analysis of Wind Farm Operation
2.2 Equipment Suppliers and Price Analysis of Wind Farm Operation
2.3 Labor Cost Analysis of Wind Farm Operation
2.4 Other Costs Analysis of Wind Farm Operation
2.5 Manufacturing Cost Structure Analysis of Wind Farm Operation

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3 Technical Data and Manufacturing Plants Analysis
3.1 Capacity and Commercial Production Date of Global Key Manufacturers in 2014
3.2 Manufacturing Plants Distribution of Global Key Wind Farm Operation Manufacturers in 2014
3.3 R&D Status and Technology Source of Global Wind Farm Operation Key Manufacturers in 2014
3.4 Raw Materials Sources Analysis of Global Wind Farm Operation Key Manufacturers in 2014

4 Production Analysis of Wind Farm Operation by Regions, Technology, and Applications
4.1 Global Production of Wind Farm Operation by Regions (US, EU, China, Japan, etc.) 2010-2015
4.2 Global Production of Wind Farm Operation by Technology 2010-2015
4.3 Global Production of Wind Farm Operation by Applications 2010-2015
4.4 Price Analysis of Global Wind Farm Operation Key Manufacturers in 2015
4.5 US Capacity, Production, Price, Cost and Revenue of Wind Farm Operation 2010-2015

5 Sales and Revenue Analysis of Wind Farm Operation by Regions
5.1 Global Sales of Wind Farm Operation by Regions (US, EU, China, Japan, etc.) 2010-2015
5.2 Global Revenue of Wind Farm Operation by Regions (US, EU, China, Japan, etc.) 2010-2015
5.3 Global Price Analysis of Wind Farm Operation Sales by Regions (US, EU, China, Japan, etc.) 2010-2015
5.4 Global Price, Cost and Gross of Wind Farm Operation 2010-2015

6 Analysis of Wind Farm Operation Production, Supply, Sales and Market Status 2010-2015
6.1 Capacity and Production of Wind Farm Operation 2010-2015
6.2 Production Market Share Analysis of Wind Farm Operation 2010-2015
6.3 Sales Overview of Wind Farm Operation 2010-2015
6.4 Supply, Sales and Shortage of Wind Farm Operation 2010-2015
6.5 Import, Export and Consumption of Wind Farm Operation 2010-2015

7 Analysis of Wind Farm Operation Industry Key Manufacturers
7.1 Longyuan Electric power
7.2 Datang Corporation
7.3 Huaneng Group
7.4 Guohua Power
7.5 China Guangdong Nuclear Power Holding Co., Ltd.


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