CDRH processes requests for certificates or permits and submissions of simple notifications for the exportation of medical devices, including radiation emitting electronic products.
In order to export a Medical Device to China, the product has to be registered with the NMPA in China (National Medical Product Administration), before known as CDFA (China Food and Drug Administration).
While the regulation simplified the approval process for low-risk medical devices, manufacturers of higher-risk medical devices now need to provide more extensive technical and clinical information to meet pre-market approval requirements.
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Navigate China's medical device import/export regulations. Understand licensing, compliance, customs, and key requirements for smooth global trade.
The Chinese medical device market is currently worth about $2.5 billion and it is growing rapidly. Exporting to China is becoming easier and tariffs on most.
Furthermore, visual representations like the one above help us fully grasp the concept of Export Permit Necessary For Exporting Medical Devices To China.
The Export Reform and Enhancement Act of 1996 authorized the Food and Drug Administration (FDA) to permit the export of certain medical devices.
