China’s National Medical Products Administration (NMPA) in May published adjustments to its guidelines for clinical trials of medical devices. The changes affect the process of gaining approval for clinical trials of new devices under new requirements, instituted early this year, which mandate using only testing labs approved by the NMPA.
Under the new guidelines, which apply to all renewing or applying for new device product registrations, firms may request a consultation with the NMDA’s Medical Device Technology Center (CMDE). If they do not receive feedback within 60 days of their request, they may proceed with the clinical trial.
The CMDE will publish the name, address and acceptance number of the applicant, along with the product name, product model specification, structure, and composition of the medical device, on its website. Applicants will be informed online only of the results of the inspection of the clinical trial sites.