Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug Administration (CFDA), now the National Medical Products Administration or NMPA. The NMPA has strict regulatory requirements, especially for foreign manufacturers who want to import their products to China. It's important to understand the requirements before you begin the registration process.
In this white paper, we'll answer your biggest questions about what it takes to start selling your medical device in China. You will learn:
You'll learn all this and more in this 8-page white paper.
在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械,并且符合MDR 2017/745下的一般安全和性能要求(GSPR)。法定制造商将验证是否符合所有相关的欧盟要求,并必须在其欧盟符合性声明(DoC)中声明这一点。此外,高风险器械(MDR下
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