medicines-medical devices-regulatory affairs
The EMA has launched a new pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). This pilot programme is part of EMA’s regulatory support for the expert panels on…
Last updated: 2 August 2024 To see updates, click on the ‘+’ sign below. SPOR status update This EMA webinar was held on 10 July 2024. It covers the following topics: Source: EMA Template for notified body confirmation letter of…
This post concerns the introduction of temporary new arrangements by the TGA, for GMP inspections of: When were the temporary new arrangements for GMP inspections introduced and what are they called? The temporary new arrangements for GMP inspections were introduced…
Last updated: 13 July 2024 To see updates to this post, click on the ‘+’ sign below. This post summarises the proposal and main events so far concerning the extension of the IVDR transition periods. Timeline of events Date Event…
Last updated: 14 July 2024 Click on the + sign below to see the updates to this post. ICH eCTD v4.0 package updated The ICH eCTD v4.0 package has been updated in response to the change requests and/or discussion within…
Date Guidance No About the guidance 25 Jun 2024 MDCG 2024-10 Clinical evaluation of orphan medical devices – June 2024 This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the MDR of medical devices…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2024 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Draft This guidance is intended to assist sponsors…
The TGA has published a list of changes to medical device regulations. The table below is an attempt to present the information in a manner such that it can be read easily. Devices or audit application requirements Changes already in…
Last updated: 6 June 2024 See updates at the end of the post. New Paediatric submissions are mandatory via IRIS platform from 4 June 2024 From 4 June 2024, the following types of new paediatric submissions must be submitted out via IRIS: To…
Information on changes to the following guidance documents are provided below: Changes to the Guidance document Time limits for authorisation applications The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for…
Last updated: 23 May 2024 To view updates, click on the ‘+’ sign below. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination (DDC)…
The MHRA: The proposed framework is still in draft, and the final version would be integral with the future core regulations. With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will…