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Latest Guidebook for China’s Good Clinical Practice (GCP) for Medical Devices: How to Use Overseas Clinical Trial Data to Apply for Marketing Authorization in China

In recent years, China’s healthcare market landscape and regulatory framework is undergoing rapid changes. Facing a gigantic population and rapid population aging as well as growing medical care demand, the Chinese government, on one side, accelerated the priority approval of innovative drugs and medical devices and relaxed the market access for overseas drugs and medical devices, on other side, intensified the supervision and administration for drugs and medical devices on the post—marketed and...

 8/1/2019 |  Research Report |  Access China Management Consulting Ltd


Latest Chinese Guidebook for Medical Device Adverse Events Reporting, Monitoring and Re-Evaluation (2019 Edition)

Executive Summary China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. Along with sustained economic and population growth, and rapid population aging, the Chinese healthcare market has maintained annual compound growth rate above 16 % since 2010s. The statistical data showed that scale of the Chinese healthcare market has reached RMB 6464.1 billion (about equi...

  August 2019 |  Research Report |  Access China Management Consulting Ltd


Latest Guidebook for Review and Approval Procedures of Overseas Imported New Drugs for Chinese Clinical Urgent Demand (2019 Edition)

China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. Facing a gigantic population and rapid population aging, the Chinese government accelerated the priority approval of innovative drugs and relaxed the market access for overseas drugs to cope with the clinical urgent demand. In recent years, China’s fast-track approval time is much shorter than any other count...

 5/1/2019 |  Research Report |  Access China Management Consulting Ltd


Latest Chinese Guidebook for Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices (2019 Edition)

China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. Along with sustained economic and population growth, and rapid population aging, the Chinese healthcare market has maintained annual compound growth rate above 16 % since 2010s. The statistical data showed that scale of the Chinese healthcare market has reached RMB 6464.1 billion by 2017(about equivalent to U...

 8/1/2019 |  Research Report |  Access China Management Consulting Ltd


Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market

Executive Summary Facing a gigantic population and rapid population aging, China’s regulatory framework for medical devices is undergoing radical changes. In order to promote the implementation of a strategy of healthy China, transform the treating diseases as focal points into the people’s health as centre, prevent and control the major diseases, actively respond to the aging of the population and accelerate the development of aged healthcare service to give the populace with a full range and ...

 8/1/2019 |  Research Report |  Access China Management Consulting Ltd


Latest Guidebook for Chinese Medical Device Recall Regulations (2019 Edition)

China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. Facing a gigantic population and rapid population aging, China’s regulatory framework for medical devices is undergoing radical changes. In order to promote the implementation of a strategy of healthy China, transform the treating diseases as focal points into the people’s health as centre, prevent and contro...

 8/1/2019 |  Research Report |  Access China Management Consulting Ltd


China’s Governance System: What the World Needs to Know About the Oriental Economic Superpower

Since the “reform and opening up to outside world” policy was enforced in 1978, nearly 40 years of fast-paced economic growth has made China the world’s second largest economy and the world’s largest exporter. Its economy has been deeply integrated into the global economy and joined into the existing global order, led its economy to one that is closely interdependent with other global powerhouses, especially the United States. As China’s economic and strategic clout has grown over the last four ...

 8/1/2019 |  National report |  Access China Management Consulting Ltd