NMPA Registration and medical device export to China

In order to export a Medical Device to China, the product has to be registered with the NMPA (National Medical Product Administration), before known as CDFA (China Food and Drug Administration). Exporting a Medical Device to China requires knowledge of the different steps that has to be taken in order to successfully put the product on the Chinese market.

Classification Medical Devices China

In general, Medical Devices are classified in three categories; Class I, II and III. With regard to exporting these devices to China, one has to be aware of the different steps each product class requires.

  • Medical Class I
    Class I Medical devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.
  • Medical Device Class II and III
    A Medical device of Class II means the device is classified with moderate risks. These devices shall be strictly controlled and administered to ensure their safety and effectiveness. Medical devices of Class III are devices with relatively high risks. These medical devices are strictly controlled and administered through special measures.

Representative NMPA

Keep in mind that companies that export Medical Devices in Class I and II are obliged to have a representative office established in China that serves as a direct agent between the company and the National Medical Products Administration (NMPA). Since Certification Experts has an office in China, we can serve as your representative for the NMPA.

If you have any questions regarding NMPA registration, China medical device regulations or medical device export to China or need a NMPA representative, please contact us. Our experts can fully assist you in the process of getting your product NMPA approved.

Also learn more about a CE mark for a medical device and everything there is to know about a legal manufacturer of a medical device.

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