medicines-medical devices-regulatory affairs
Last updated on 26 November 2021. See update at the end of the post. Can ePI be delivered and implemented in the EU in the near term? This is a question that must be addressed with the utmost vigour. What…
The European Commission has written to the Medical Devices Coordination Group (MDCG) updating it on the EU-Turkey Customs Union for medical devices. According to the letter, the final steps to update the EU-Turkey Customs Union for medical devices have been…
What are the implications of the new Medical Devices Regulation (EU) 2017/745 (MDR) becoming applicable, for Switzerland? Until 26 May 2021, Switzerland had been participating in the European Union (EU) internal market for medical devices through a specific chapter of…
Swissmedic is revising its requirements for combination products. In its publications from 2017 (SMJ 06/2017), 2019 (SMJ 10/2019) and 2020 (SMJ 05/2020), Swissmedic provided information on integral and non-integral combination products and specified when the new requirements will take effect.…
In a PMDA statement from its chief executive, review routes facilitating earlier marketing of innovative medical devices are detailed. The statement emphasises that one of the most significant roles of the PMDA is to establish a fit for purpose review…
The TGA, Australia has updated its guidance on the Declaration of Conformity (DoC) procedures for certain Class I medical devices. The guidance was originally published in December 2020. It has now been updated to Version 1.1 to include Class I…
The TGA, Australia has provided guidance on the medical device inclusion process. Who is the guidance for? It is intended for sponsors applying for inclusion of a ‘kind of medical device’, including IVD medical devices, in the Australian Register of Therapeutic Goods (ARTG).…
The European Medical Devices and Coordination Group (MDCG) has endorsed a notice on the impact of genetic variants on SARS-COV-2 IVD medical devices. The notice (MDCG 2021-7) is addressed to manufacturers and authorised representatives of in vitro diagnostic medical devices (IVDs) with…
The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals. The 17 page guidance document outlines: the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines…
Could AI and nanotechnology make cancer therapy affordable for all? It could according to Professor Liesbet Lagae, Director of Life Science Technology Activities at IMEC. In this article, Professor Lagae starts be talking about the benefits of Chimeric Antigen Receptor…