RESOURCES LIBRARY

Whitepapers, Guidelines, Legislação, Artigos

Principles of Labeling for Medical Devices and IVD Medical Devices

The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices and IVD medical devices and support the IMDRF Essential Principles of Safety  and Performance. Specifically, this document provides guidance on the content of...

Unique Device Identification system (UDI system) Application Guide

The IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) provides a framework for the regulatory authorities that intend to develop their UDI systems in a globally harmonized approach. This UDI system Application Guide is to be used as a supplement to the IMDRF UDI Guidance...

Technical document on cosmetic claims

The purpose of this document is to provide guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Technical document on cosmetic claims Agreed by the...

Updated: ICH Q12: A Framework for Managing Post-Approval CMC Changes

The US Food and Drug Administration (FDA) made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical lifecycle management. Q12 Technical and Regulatory Considerations for Pharmaceutical...

DATA INTEGRITY REFERENCES

REFERÊNCIAS: .-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO...

ISO 13485 :2016 Versão para download

A norma ISO 13485 tem como objetivo  garantir o cumprimento dos requisitos legais, a gestão dos riscos e a manutenção dos processos de projecto, produção e distribuição de dispositivos  médicos. A Formiventos disponibiliza a nova versão para download : Medical devices...

PGEU Best Practice Paper: Pharmacovigilance and Risk Minimisation

This best practice paper outlines the evolution of pharmacovigilance in Europe, particularly in the context of the fifth anniversary of the 2012 EU pharmacovigilance legislation and recent developments in the field. Additionally, this paper describes the varied role...

DATA INTEGRITY REFERENCES

.-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO...

Looking to the Future in Regulatory Affairs

By Oliver Cox and Siegfried Schmitt, PhD Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and...

New rules for Novel Food

REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2015 .on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of...