Australia: Updated Checklist of Essential Principles for Medical Devices
In Australia, the Essential Principles represent a set of mandatory requirements designed to ensure that Medical Devices placed on the [...]
FDA: eSTAR Implementation Date Announced for de Novo Applications in Updated Guidance
The US Food and Drug Administration (FDA) recently announced in a guidance issued on August 23, 2024, entitled 'Electronic Submission [...]
Amendments to the Recall Regulation and MDEL in Canada: SOR 2024-136
On July 3, 2024, Regulation SOR 2024-136 was published in the Canada Gazette, an update that makes significant changes to [...]
FDA: Published Fees for Fiscal Year 2025
On July 31, 2024, the U.S. Food and Drug Administration (FDA) officially announced in the Federal Register the new medical [...]
EU: The Artificial Intelligence Act (AIA) included in the EU Official Journal
The European Commission has made available the final text of the Artificial Intelligence Act (AIA), the world's first comprehensive regulatory [...]
News for Economic Operators: Incident Guideline and Registration Form
As of June 3, 2024, the 'Guidance document Incident Economic Operators' is valid in Switzerland. This is a document [...]
MDCG 2021-5 Rev. 1: Updated ‘Guidance on Standardisation for Medical Devices’
On July 2, 2024, the Medical Device Coordination Group (MDCG) published the updated version of the 'Guidance on standardisation [...]
Regulation (EU) 2024/1860: Eudamed Plan Amendments And Legacy IVD Transitional Periods
On July 9, 2024, Regulation (EU) 2024/1860 of the European Parliament and of the Council amending the European Regulation [...]
MEXICO: First Authorisations of Innovative Software as a Medical Device (SaMD)
COFEPRIS, the Mexican regulatory authority, in May 2024 officially announced the approval of the first software as a SaMDmedical [...]
EMA: Updated Questions and Answers Guidelines on Devices Used in Combination with Medicines
In May 2024, the European Medicines Agency (EMA), together with the Coordination Group for Mutual Recognition and Decentralised Procedures [...]
BRASIL: Reliance Programme Accelerated Access for Medical Devices Already Registered in Other Countries
As of June 3, 2024, it will be possible to place one's high-risk Medical Devices in Brazil, relying on [...]
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 [...]
