Starting this month, medical device manufacturers will be required to use an internationally standardized electronic system to submit their products for approval in China.
China’s National Medical Products Administration (NMPA) began implementing the Electronic Regulated Product Submission system (E-RPS) on June 24. The system has been adopted internationally by the International Medical Device Regulators Forum. Like most digitally-based systems, it is designed to eliminate cumbersome paperwork, standardize submissions, improve efficiency and strengthen the ability of authorities to search, monitor and store files.
The adoption of the electronic system does not coincide with new regulatory requirements.