China Food and Drug Administration (CFDA) Registration is necessary in order to bring a medical device onto the Chinese market. In order to CFDA register a medical device the medical device must be tested and certified in accordance with the CFDA guidelines.
Exporting a medical device to China requires knowledge of the different steps that have to be taken in order to successfully bring the product onto the Chinese market. CE Medical is able to guide your company as we have subsidiary offices in China which have the expertise in house to ensure a successful and efficient CFDA certification of medical devices exported to or produced in China.
In China, medical devices are classified in three categories, namely Class I, II and III. With regard to exporting these devices to China, the different steps for each class must be taken into account.
Class I medical devices are deemed to be low risk and are therefore subject to the least regulatory controls. Click here for our Class I flow chart.
CLASS II AND III
A medical device of Class II is a device 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. Click for our Class II and III Flow chart.
Note that companies that export medical devices of 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 CFDA.
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 41 75 81 or fill out our contact form.