On December 23, NMPA published new catalogs of medical devices and IVDs products which are eligible for the clinical trial exemption when applying for the product registration in China.
As compared to 2018, new lists are comprised of newly added 148 medical devices and 23 IVDs products, as well as the revised details of 52 products (48 medical devices and 4 IVDs) which the product name and the description have been amended. Now, a total of 1003 medical devices and 416 IVD products are been considered for clinical trial exemption in China.
Among the new additions, a few examples are infusion cathether, arthroscopy scalpel, injection needle, electrocardiography, control system for surgical equipment and so on. Kindly consult us at firstname.lastname@example.org for further details on whether your products are relevant and how to proceed with the product registration.
For latest NMPA updates, visit http://english.nmpa.gov.cn/