GMDN Agency White Paper on Medical Device Nomenclature
The GMDN Agency has published a white paper titled “Medical Device Nomenclature”. This paper provides an in-depth…
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Amending Consultation Period for Regulation (EU) 2022/1107
The European Commission has initiated a consultation period to consider amendments to Regulation (EU) 2022/1107, which was originally adopted in…
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…
Australia’s Prescribed List: Reimbursement and Application Tiers
In a previous article (available here), we provided an overview of Australia’s Prescribed List, the medical device reimbursement process…
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…
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…
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…
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