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China is one of the fastest growing global economies with a one-fifth population in the world. Nowadays Chauncey Gardner-Johnson Youth Jersey , China has become the worlds 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 an annual compound growth rate above 16 % since the 2010s. The statistical data showed that the scale of the Chinese healthcare market has reached RMB 6464.1 billion (about equivalent to US$973.5 billion) by 2017. Among them, the total value of medical device sales was RMB 663.2 billion (US$95.2 billion) with the annual compound growth rate of 20.27% by 2017. Medical devices have been widely used in the process of disease prevention Erik McCoy Youth Jersey , diagnosis, therapy, care, and rehabilitation.


However Alvin Kamara Youth Jersey , large and medium-sized medical devices, high-end medical equipment and high-value medical materials are mainly relying on imported, such as the high-tech and high-valued imaging systems and navigation and positioning systems. Facing a gigantic population and rapid population aging, the Chinese government Marshon Lattimore Youth Jersey , on one side, accelerated the priority approval of innovative medical devices and relaxed the market access for overseas medical devices, on another side, intensified the supervision and administration for medical devices at the post鈥攎arketed. In recent years Tre'Quan Smith Youth Jersey , China鈥檚 fast-track approval time is much shorter than any other country, which attracts more and more overseas medical device manufacturers to enter the Chinese healthcare market. Undoubtedly the Chinese healthcare market of nearly 1.4 billion populations is the huge business opportunities for the overseas medical device manufacturers.


At the same time, the Chinese regulatory authorities are changing regulatory framework to intensify the supervision and administration. The Chinese 鈥淪tate Administration for Market Regulation鈥?and the 鈥淣ational Health Commission鈥?jointly issued the latest version of 鈥淢easures for Medical Device Adverse Event Monitoring and Re-evaluation鈥?in August 2018, which has been implemented on January 1 Marcus Williams Youth Jersey , 2019. This is a challenge to overseas medical device manufacturers. To capture the huge business opportunities of the Chinese healthcare market and seize a larger part of the Chinese healthcare market, how do the foreign medical device manufacturers in compliance with the latest Chinese regulations on medical devices? How do the overseas medical device manufacturers operate business smoothly in China? Most importantly, overseas and multinational medical device manufacturers should always stand ready to respond to further regulation and policy changes occurred in China.


The overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs need a thorough knowledge of the Chinese regulations for medical device adverse event reporting, monitoring and re-evaluation. China鈥檚 regulatory approach and culture are unique.


Latest Chinese Guidebook for Medical Device Adverse Events Reporting Michael Thomas Youth Jersey , Monitoring and Re-Evaluation (2019 Edition) is an essential resource for overseas and multinational medical device manufacturers to handle the medical device adverse event reporting, monitoring and re-evaluation smoothly in China, which provided a detailed guidance of comprehensive and thorough knowledge of the Chinese medical device adverse event reporting, monitoring and re-evaluation regulations.


This guidebook is organized as follows:
Chapter 2 provides a brief description of China鈥檚 healthcare market landscape and rapidly changing regulatory framework as a background for the audience.
Chapter 3 introduces the general regulations for medical device adverse event reporting Drew Brees Youth Jersey , monitoring, and re-evaluation.
Chapter 4 introduces the Chinese regulatory authorities and their respective functions and the Chinese huge medical device adverse event monitoring information network.
Chapter 5 expounds the marketing authorization holders鈥?duties and obligations, which is important for the overseas and multinational medical device manufacturers and the agents within the territory of China designated by the overseas medical device manufacturers because they must fulfill these duties and obligations that are stipulated by the Chinese regulatory authorities.
Chapter 6 expounds the medical device distributors鈥?and medical device user facilities鈥?duties and obligations, which is important for the distributors within the territory of China of the overseas and multinational manufacturers of imported medical devices because they must also fulfill their duties and obligations that are stipulated by the Chinese regulatory authorities.
ment key monitoring of certain medical devices.
Chapter 9 elaborates that the marketing authorization holders should adopt what risk control measures under what circumstances and report to the drug regulatory authorities.
Chapter 10 elaborates that the marketing authorization holders should proactively conduct the re-evalu