On June 4, the NMPA (National Medical Products Administration) published (No.57 – 2020) the guidelines for on-site inspections on standalone SaMD (Software as Medical Devices) in China. This guidance document was written in line with the NMPA‘s Medical Device GMP Appendix: Independent Software and addressed the obligations of the inspector which include, but are not limited to the following:
- Check if the GMP handbook illustrates the corporate’s structure, mission, policy and decision-making process in relation to the quality assurance projects as required
- Check if the manufacturing sites and facilities meet the standard requirements of a manufacturing environment (e.g., water-proof or anti-static) and the code of practice on the packaging, labelling and storage of SaMD
- Check and randomly inspect the filing records of the software and hardware resources (e.g., anti-virus protection, data backup and data recovery)
- Check if the research and development projects are under the surveillance of safety protocols and risk management measures
- Check if the policies have been implemented to monitor and control the quality of production, sales and after sales services, nonconforming outputs, and adverse events
On June 5, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the draft amendment of the technical review guidelines for SaMDs (Software as Medical Devices) with the dossier submission requirements for registrations, registration renewals and change of licensing items.
By Jacky Li. Contact Cisema if you would like to learn more.