Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition), New Report Launched

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, and they will come into force as October 1, 2014. The radical change of regulations on medical devices, especially for the latest “Measures for the Administration of Medical Device Registration” will bring overseas and multinational medical device manufacturers the maximum challenges and opportunities.

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition) 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.

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 apply for registration of their medical device products in China, how to comply with the latest Chinese regulations for medical device 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 medical device 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 medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their products in China.

Scope

The latest Chinese regulations for imported medical device registration and 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.

Who should buy this report?

• Overseas medical device manufacturers wishing to enter into the Chinese medical device market.
• Multinational medical device manufacturers have penetrated into the Chinese medical device market.
• Companies interested in understanding the latest Chinese laws and regulations for medical device product clinical trials.
• Senior executive officers engaging in regulatory affairs for exporting medical devices into Chinese lucrative medical device market.
• Senior executive officers engaging in conducting clinical trials for exporting medical devices into Chinese lucrative medical device market.

Report Highlights

• An overview of the latest Chinese applicable regulations for imported overseas medical device registration and recordation.
• What the Chinese regulations on medical devices are undergoing earthshaking changes?
• An overview of organizational structure of Chinese regulatory authorities for imported medical device registration and recordation to give the direction of gateway for imported medical device registration and recordation.
• The knowledge preparation before application of imported overseas medical device registration and recordation 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 lates Chinese regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices.
• The lates Chinese regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices.
• The detailed Chinese medical device classification.
• The rights of human subjects and every party’s responsibilities in clinical trials for imported overseas medical devices in China.
• The practical guidance for application of imported overseas medical device 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 medical device registration, also from how to compile application documents, how to conduct clinical trials for imported overseas medical devices to the application for approval of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.
• The practical guidance for alteration registration and renewal registration of imported overseas medical devices, 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 latest Chinese involving with the imported overseas medical device registration and recordation, which cover “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)”, “Provisions for Clinical Trials

Spanning over 194 pages “Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)” report covering Executive Summary, Analysis and Research for Radical Change of Chinese Regulations on Medical Devices, Chinese Applicable Regulations for Medical Device Registration, An Overview of Chinese Regulatory Authorities for Imported Medical Device Registration, Knowledge Preparation before Application of Imported Medical Device Registration, Knowledge Preparation before Application of Imported Medical Device Registration, Medical Device Classification, Rights of Human Subjects and Every Party's Responsibilities in Clinical Trials for Imported Medical Devices, Application for Imported Medical Device Recordation, Application and Approval for Imported Medical Device Registration, Application and Approval for Alteration Registration of Imported Medical Devices, Application and Approval for Renewal  Registration of Imported Medical Devices, Supervision and Administration for Application and Approval of Imported Medical Device Registration, Practical Guidance for Application of Imported Medical Device Recordation, Practical Guidance for Application and Approval of Imported Medical Device Registration, Practical Guidance for Alteration Registration and Renewal Registration of Imported Medical Devices, Appendices, Appendix. This report Covered 3 Companies - GE, Siemens, Philips.

Know more about this report at : http://mrr.cm/ZXS