Engagement with External Stakeholders Session – May 18, 2021 – WHO

WHO Relevant Recent Publications on Good Regulatory Practices, Good Reliance Practices and Post-market Surveillance were introduced by the leaders responsible for their development at the WHO, with the purpose to get the Coalition’s members becoming familiar with them and promote a wider utilization.

Presentation on Good regulatory practices for regulatory oversight of medical products and Good reliance practices in regulatory decision-making: high-level principles and recommendations by Marie Valentin is available in English.

Presentation on Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics by Leticia Megias /Anita Sands is available in English.

Links to the documents in English and to non-official translations to Portuguese and Spanish are available as follows:

Presentations

WHO Good Regulatory Practices and Good Reliance Practices – Marie Valentin – WHO – Global
Good Regulatory Practices
Good Reliance Practices
WHO guidance on post-market and market surveillance of medical devices including IVDs – Leticia Megias Lastra – WHO – Global

REGULATORY COALITION PRINCIPAL MEMBERS