Which documents are needed to file a class I medical device with the NMPA or a local authority – from the filing form and technical requirements to test reports, IFU and manufacturing information.
Applicable regulations, how to confirm class I status, where domestic and imported class I devices are filed, and how the filing procedure works in China.
Five criteria for assessing a medical device cybersecurity research report – completeness, accuracy, depth, logical coherence – and the standards to reference.
How the 22 classification rules of MDR Annex VIII work and which conformity assessment routes (Annexes IX, X and XI) apply to class I, Is/Im/Ir, IIa, IIb and III devices.
