Update on TGA Essential Principles Checklist
The Therapeutic Goods Administration (TGA) Essential Principles Checklist V1.2 was recently updated in addition to the previous updates in May…
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EU 2024/1860 Swissmedic Updates for IVD Supply in Switzerland
On 9th July 2024 (with an adoption date of 13th June 2024), Amendment Regulation EU 2024/1860 came into effect with…
Regulatory Framework for Reprocessed Single-Use Devices
The practice of reprocessing devices that are intended for single use began in hospitals in the late 1970s. This practice…
New FDA Medical Device User Fees
Under the Medical Device User Fee Amendments (MDUFA), under the User Fee System of the FDA, medical device companies must…
New Swissmedic Database for Economic Operators and Devices
The Swissmedic database, swissdamed, is a new platform for the registration of economic operators and medical devices, including In Vitro…
MHRA 60 Day Notice Rule for UKCA/CE Marking
If you need to perform a clinical investigation in order to obtain UKCA/CE/CE UKNI marking for your device, the MHRA…
EU Renews UDI Issuing Entities for Medical Devices (2024-2029)
On July 30th, 2024, the European Commission implemented Decision (EU) 2024/2120 regarding the renewal of issuing entities…
TGA Draft Guidance and Essential Principle 13B Updates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 The first is a draft guidance consolidating various documents to assist with…
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…
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