News & Trends
Procurar
Recentes
- EMA Article 57 Q&A Version 1.15 (9 September 2026)
- EMA guidance on Electronic product information (ePI) submission during centralised procedures
- EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Device Regulation (2017/746) – Impact on international registrations. Middle East and Africa focus
- IMDRF Document Implementation Report. 1 September 2026
- EU Regulatory News : IVD Classification Rules – MDCG 2020-16 Rev.5
- Revised version of EU GMP Annex 19: Reference and Retention Samples
- Evaluation of Therapeutic Equivalence. Guidance for Industry
- FDA Considerations for the Regulation of Generative Al-Enabled Medical Devices: Discussion Paper and Request for Feedback