SWITZERLAND: Marketing and Legacy Devices
Taking a step back in time, it is recalled that Switzerland has been considered a Third Country for Europe [...]
EU: Microplastics Reduction for Medical Devices
With the Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No. 1907/2006, the European [...]
IMDRF: Published Guidance on Safety and Performance Principles for Medical Devices
On April 26, 2024, the International Medical Device Regulation Forum (IMDRF) published "Essential Principles of Safety and Performance of [...]
Thema CORP Joins LSPA and Philadelphia Chamber of Commerce
Thema CORP, the US-based Thema subsidiary, is pleased to announce its recent membership in the Philadelphia Chamber of Commerce and [...]
BRAZIL: B-GMP Extended to Four Years
On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing [...]
EUROPE: Updated MDCG Guideline on Clinical Investigation Plan
In March, the Medical Device Coordination Group (MDCG) published the Guidance on the content of the Clinical Investigation Plan [...]
EUROPE: Deadline to Implement MDR Quality System and Application
On March 20, 2023, Regulation 2023/607 was published in the Official Journal of the European Union - EUR-Lex (Regulation [...]
AUSTRALIA: Updated Medical Device Labelling Requirements
On February 19, 2024, the Australian regulatory authority, Therapeutic Good Administration (TGA), updated the requirements regarding the labelling of [...]
CANADA: Increased Fees and Upcoming Deadlines for Medical Devices
April 1, 2024, represents a very significant date for the Medical Devices market in Canada. First, from this date, [...]
EUROPE: Harmonised Standards in the Medical Devices Industry
On March 6, 2024, the European Commission amended Implementing Decision (EU) 2021/1182 on harmonised standards for single-use medical gloves, [...]
EUROPE: Updated MDCG Guideline on Medical Device Nomenclature
Last February 2024, the Medical Device Coordination Group (MDCG) updated the MDCG 2024-2 Procedures for the updates of the European [...]
EUROPE: Proposed Extension for IVD Devices
On January 23, 2024, the European Commission proposed to extend the transition period provided for in Regulation (EU) 2017/746 for [...]
USA: Quality Management System for Medical Devices Will Follow ISO13485
On February 2, the FDA published the Quality Management System Regulation (QMSR) Final Rule on its official website, amending the [...]
EGYPT: Changes in Medical Devices Import Conditions
The Egyptian Drug Authority (EDA) announced that, as of January 2 2024, both foreign importers and manufacturers wishing to [...]
BRAZIL: Revision of IVD Device Regulation
In December 2023, the Brazilian National Health Surveillance Agency (ANVISA) updated the Regulation Resolução Da Diretoria Colegiada - RDC [...]
EUROPE: Published the MDCG Guideline on Products without an Intended Medical Purpose
Last December, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2023-6, Guidance on demonstration of equivalence for [...]
AUSTRALIA: Clearer Requirements for Clinical Evaluation
On November 23, the Therapeutic Good Administration (TGA) published the revision of the Clinical Evidence Guidelines Version 3.2, in [...]
EUROPE: Acceleration Needed for EC MDR and IVDR Certifications
Last November, the Medical Device Coordination Group (MDCG) approved the revision of the MDCG 2022-11, Notice to manufacturers and [...]
