On July 23, 2021, the NMPA (National Medical Products Administration) published the revised draft of the “Required Working Measures on Self-Testing for the Registration of Medical Devices” as a supporting regulation to Order 739.
Since the implementation of Order 739 on June 1, 2021, self-testing of medical devices and IVDs is proposed in addition to local type testing in China at NMPA certified laboratories. However, manufacturers should wait until the supporting draft regulation is finalized before starting their own self-testing.
According to the revised draft regulation, overseas applicants must ensure that the testing laboratories have already obtained the accreditation by its local government, and should always follow the on-site verification guidelines of the China QMS, otherwise, the reports will not be recognized by the NMPA for medical device registration in China.
Compared to the initial draft, the revised draft added the required qualifications and capabilities to carry out self-testing in terms of personnel, on-site settings (equipment and facility), samples, quality control, record-keeping, management system, reference standards, etc.
Our initial view is that implementing such self-testing processes may save manufacturers 2 or more months in their China registration. However, implementation of China QMS will not be straightforward and will also increase the likelihood of overseas factory inspections.
By Colleen Xu and Jacky Li. Contact Cisema if you would like to learn more.