NMPA Announces Digitalization of Medical Device Regulatory Documents

The National Medical Products Administration (NMPA) has announced a transition to digitalize regulatory documentation for medical devices. Effective June 1, 2024, this digitalization will apply to scenarios where medical devices are not approved for marketing, market filings are terminated for review, and product inserts are not approved for changes, among other related circumstances. The electronic documents issued under this new system will carry the same legal weight as their paper counterparts. Applicants will be able to access and search for these digital documents through the NMPA’s government service portal.- Flcube.com