Theoretically, all medical devices and IVDs are reuired to perform clinical trials in China asa requirement to get a registration approval. There are, however, exclusions for certain medical devices classified as "Clinical trial exempted. These devices are not required to undergo clinical trials.
Clinical trial is the most complicated, least predictable, most time-consuming, most expensive process in the product development. With the increasing demand of local clinical data by the Authorities, global manufacturers often struggle with the lack of specialized partners, language barriers, local staff shortage when conducting clinical trials in China.
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The OSMUNDA Group looks forward to discuss your concerns and collaborate on the success of your device. Contact us!