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Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices
Date:9/3/2014

MUMBAI, India, September 3, 2014 /PRNewswire/ --

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 past 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 on 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.

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Those medical devices that have not been granted the certificate of marketing authorization of medical devices by the government authorities of the country or region of origin will be intercepted outside the door of Chinese medical device market. How do you comply with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How to seize a bigger Chinese medical device market? The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese r
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SOURCE Bharat Book Bureau
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