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.
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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.
Those medical devices have not been granted the certificate of marketing authorization of medical device issued 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 in compliance 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?
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The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative medical device market, and cause trouble for your business smoothly in China.
Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From 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.
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.
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