In order to export a Medical Device to China, the product has to be registered (CFDA Registration) according to the China Food and Drug Administration (CFDA) guidelines. 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. 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.
Note! 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 China Food and Drug Administration.
If you have any questions regarding this article or if you have a general question with regard to product certification please call +31 (0) 294 48 33 55 or fill out our contact form. CE Solutions and Certification Experts can fully assist you in getting CFDA approval for your product.