Personal Protective Equipment (PPE): Regulatory Requirements
Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their…
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Guiding Principles for Medical Devices: AI and Machine Learning
Nearly three years have passed since the US FDA, Health Canada, and UK MHRA jointly identified ten guiding principles in…
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…
Medical Device Registration in Egypt
Egypt is an attractive market for medical device manufacturers, but navigating the specific requirements for medical device registration in…
TGA Draft Guidance and Essential Principle 13B Updates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 The first is a draft guidance consolidating various documents to assist with…
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