TGA Draft Guidance and Essential Principle 13B Updates
The TGA released updates on two important guidances. The first is a draft guidance consolidating various documents to assist with…
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EU Releases New Template for Notified Body Confirmation Letter
The European Commission has released a new template for the notified body confirmation letter, a critical document outlining the…
CDSCO Post Approval Changes in Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) mandates that any modifications to medical devices post-approval, such as changes in…
EU Regulation 2024/1860: Key Changes for IVDR Compliance
New regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR): Regulation (EU) 2024/1860: Gradual roll-out of EUDAMED, the obligation…
Regulation (EU) 2024/1860: IVDR Extended Transition Periods
The publication of this Q&A is intended to assist manufacturers and other economic operators in understanding the…
Updated EUDAMED Timeline for Modules
The European Commission (EC) has published an updated EUDAMED timeline in relation to the roll out of…
Ensuring ISO 13485 QMS Compliance
Organizations claiming compliance with ISO 13485 or possessing…
MDCG 2020-16 Guidance: Classification Rules for IVDs
The Medical Device Coordination Group (MDCG) has published an update to guidance document MDCG 2020-16 Rev.3 –…
WHO and GMDN Medical Device Collaboration for Communication
The GMDN Agency was established to provide a system that allows an exchange of medical device information for Health Authorities…
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