Author name: EVERBIZ Editorial Team

What ISO/IEC 27001 is, where the IVDR sets information security requirements, and how ISMS clauses map to key documents.

Key concepts of China’s NMPA guideline for the registration review of AI medical devices: definitions, device types, review principles and the algorithm research report.

Scope, protection levels and capabilities required by the NMPA cybersecurity guideline, plus the cybersecurity information needed in technical requirements and instructions for use.

The structure of the cybersecurity research report required for NMPA registration: basic information, implementation process, vulnerability assessment and conclusion.

Applicable Chinese regulations and standards, scope, and the content required in the cybersecurity part of an NMPA registration dossier.

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.

Scope, accessibility requirements, obligations of economic operators and service providers, exemptions, market surveillance and timelines of the European Accessibility Act.

How FDA eCopy and eSTAR compare with China’s NMPA eRPS system for medical device submissions – purpose, scope, functions and submission routes.

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.

Regulations, classification, combination products, registration routes, dossier requirements and registrant obligations for class II and III medical devices in China.