Predetermined Change Control Plans (PCCP) for Medical Devices
The FDA has recently issued a draft guidance for Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance,…
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eMDR Enhancements: FDA Rolls Out Regular Updates
The FDA is now implementing enhancements to the Electronic Medical Device Reporting (eMDR) system on a regular schedule except for…
MHRA Quarterly Summary Report Template Update
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an important update that builds upon previous…
FDA Guidelines: Medical and In Vitro Diagnostic Device Classification
Classifying your medical device or in vitro diagnostic device (IVD) under the FDA is one of the first steps in…
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…
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…
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