Medical Device Registration in Mexico with COFEPRIS
Navigating medical device registration in Mexico with the Federal Commission for Protection against Health Risks (COFEPRIS) can be challenging for…
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eSTAR Guidelines for Successful FDA Submissions
All medical devices seeking to market into the US may require multiple submissions of various types to the Food and…
New Post-Market Surveillance Rules for UK Medical Devices
The publication of Statutory Instruments 2024 No. 1368 introduces significant amendments to the Medical Device Regulations in Great Britain. These…
TGA Consultation: Medical Device Audit Framework
The Therapeutic Goods Administration (TGA) has announced a public consultation on two draft guidance documents as part of its new…
New MDR and IVDR Factsheet from the European Commission
A new MDR and IVDR Factsheet for healthcare professionals and health institutions was published on 18th December by the European…
Team NB Releases Document on the MDR Certification Process
Team NB has released a new document titled “MDR Certification Process (including Pre-application, Application, and Post-application Phases) – Consensus Document.”…
EU MDR/IVDR Update: Revised MDCG 2019-13 Sampling Guidance
The European Union has released an update to MDCG 2019-13 rev.1, the guidance document for the sampling of Class IIa…
Member States Endorse COMBINE Program for Medical Devices
Member States have officially endorsed the COMBINE program, a significant initiative aimed at streamlining the combined studies of medicines and…
In-House Medical Device Manufacturing within Great Britain
A new guidance document has been published regarding the in-house manufacturer of medical devices within Great Britain. This guidance is…
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