Regulatory
Rapporteur
Write to the Editor at publications@topra.org
February 2024 | Vol. 21 | No.2
EDITORIAL
Sink or swim: the changing
tides of device regulation
In this edition of Regulatory Rapporteur, we embark on an exploration of the nuanced regulatory landscapes shaping the future of healthcare, medical devices and diagnostics, digital health and pharmaceuticals.
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By Esteban Herrero-Martinez and Dejan Brkic
FOCUS
AI meets medtech: big opportunities
require a measured approach
The integration of artificial intelligence (AI) into digital health technologies (DHTs) has the potential to improve patient care and strengthen diagnostic capabilities. However, the US, the UK and the EU lack harmonised regulatory guidance for DHTs. This article discusses the opportunities for AI in healthcare and the varied approaches to DHT regulation in these three territories.
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By Jacques du Preez
FOCUS
Chemical characterisation: a critical first
step for medical device development
Chemical characterisation is an essential component to demonstrate the biological safety of a medical device before pre-clinical and clinical assessment. This article discusses how to integrate chemical characterisation into the medical device development process to ensure the delivery of safe devices to market.
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By Jocivania Oliviera da Silva and Marielle Fournier
FOCUS
EU MDR implementation – what is changing
for the medical device industry?
The transition period for legacy devices under the Medical Device Regulation (MDR) has been extended to between 31 May 2026 – 31 December 2028 depending on risk class. This article outlines the key actions that manufacturers can take to ensure a well-defined implementation plan for their legacy devices.
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By Ravi Mishra, Vivek Singh Bhagoor, Dharti Shah, Pinki Mishra, Harika Potta, Vesna Sevaljevic, Branislav Radivojevic, Deepti Jagga, Scott Krygier, Vivek Tomar andAllison Gillespie
FOCUS
The rise of FemTech and
why compliance is key
The term ‘FemTech’ is used to define devices, diagnostics and software that are tailored towards women’s health. A broad knowledge of medical device standards and regulations is required to best serve this emerging class of devices. This article outlines the key regulatory requirements and considerations for manufacturers developing FemTech products, including data privacy and quality management.
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By Heather Carre-Skinner
FOCUS
Overview of medical
device regulations in Canada
Health Canada plays a key role in shaping global regulations for medical devices to ensure the streamlined delivery of safe and effective products to patients. This article explores Canada’s regulatory framework for medical devices and the key initiatives undertaken by Health Canada to promote global harmonisation of medical device regulations.
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By Hasnaa Fatehi
STANDALONE
China drug master file: registration
pathways and requirements
In China’s rapidly evolving pharmaceutical landscape, it is essential for companies seeking market entry to understand the intricacies of drug master file (DMF) filing. This article explores the regulatory requirements associated with DMF filing in China including recent regulatory reforms and registration pathways.
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By April Wang
PODCAST
RegRapPod
In the February 2024 episode of RegRapPod, Alan Booth hears from Issue Editors Esteban Herrero-Martinez and Dejan Brkic about medical technologies.
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