NMPA Registration in China (Part 1): Class I Medical Devices Explained
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.
Regulatory News
Global medical device regulatory updates and registration guides
NMPA Registration in China: How to Judge the Quality of a Cybersecurity Research Report (Part 2)
Five criteria for assessing a medical device cybersecurity research report – completeness, accuracy, depth, logical coherence – and the standards to reference.
NMPA Registration in China: Medical Device Cybersecurity (Part 1)
Applicable Chinese regulations and standards, scope, and the content required in the cybersecurity part of an NMPA registration dossier.
EN 17161 vs EN 301 549: Key Differences and Relevance for Medical Devices
How the Design-for-All standard EN 17161 and the ICT accessibility standard EN 301 549 differ, and which one is relevant for which kind of medical device.
New EU Rules Explained (Part 1): The European Accessibility Act – Directive (EU) 2019/882
Scope, accessibility requirements, obligations of economic operators and service providers, exemptions, market surveillance and timelines of the European Accessibility Act.
Electronic Submissions at FDA and NMPA: Similarities and Differences
How FDA eCopy and eSTAR compare with China’s NMPA eRPS system for medical device submissions – purpose, scope, functions and submission routes.
FDA Medical Device User Fees for FY2025 Explained
FY2025 FDA user fees for 510(k), PMA and annual establishment registration, how payment works, and how to qualify as a small business for reduced fees.
NMPA Registration in China (Part 3): Registering Class II and Class III Medical Devices
Regulations, classification, combination products, registration routes, dossier requirements and registrant obligations for class II and III medical devices in China.
Device Classification and Conformity Assessment Routes under the EU MDR
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.