New Updates to HPRA Certificate of Free Sale Process
The National Competent Authority of Ireland, Health Products Regulatory Authority (HPRA), has updated the application certificate of free sale…
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Swissmedic’s Focus Campaign: Key Outcomes on PMS Compliance
Swissmedic conducted a focus campaign to assess compliance with the post-market surveillance (PMS) requirements of the Medical Devices…
New IVD Registration Update Under MHRA
Under a new guidance document the EU provided new guidance for the EU IVDR transition extension under Article 110. This…
Notified Body Audits: A Guide for Medical Device Manufacturers
Notified Body audits are a critical component of the conformity assessment process for manufacturers of non-self-certified devices under the…
Saudi Arabia Medical Device Registration Requirements
The Saudi Food and Drug Administration (SFDA) has aligned its medical device regulatory requirements with other major market frameworks,…
Webinar | Navigating FDA Compliance: Defining Your QMSR Journey
This webinar has now expired: To Download The Full Presentation Click…
EMDN MDCG 2025 Update: New Guidance for Medical Devices
The EMDN MDCG 2025 update has been released, incorporating feedback from the 2024 Public Consultation and the MDCG Nomenclature Working…
Swiss Medtech: Net-Zero Roadmap for Medical Device Firms
As of January 2024, The Climate and Innovation Act (KIG) has officially come into force, setting a clear pathway for…
Australia 2024 Update: Market Authorization for Medical Devices
An update to Australia’s guidance on the use of market authorization evidence from overseas regulators for medical devices, including in-vitro…
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