Global medical device regulatory updates and registration guides
What the FDA’s January 2025 safety communication on the CMS8000 patient monitor revealed, and how FDA, EU and NMPA cybersecurity requirements have tightened.
A practical structure for the performance evaluation report of an IVD under the IVDR – from product description and risk analysis to scientific validity, analytical and clinical performance.
What an IVDR performance evaluation plan must contain under Annex XIII, how to demonstrate scientific validity, analytical and clinical performance, and how to tackle common challenges.
Extended IVDR transition deadlines for legacy devices under Regulation (EU) 2024/1860, the conditions that apply and the actions manufacturers must take.
Purpose, ethics and design of IVDR clinical performance studies, the content of the clinical performance study plan (CPSP) under Annex XIII and the study report.
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.
