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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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Navigating the Canadian Regulation Framework for Medical Devices - AF Pharma's Expert
AF Pharma's team of regulatory experts can guide manufacturers through the entire process, from document preparation to submission.
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EU Representative - Clinical Trials
According to Article 74 of the CTR, if a sponsor of a Clinical Trial is not based in the EU, appoint a representative is required
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Affixing a CE Mark in your devices for EU
Some products require CE marking before they can be sold in Europe, like medical devices and machinery products.
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Do you want to have a CE mark? Follow the steps below
A CE mark logo is an essential identification for certain products in the EU, including medical devices and machinery.
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Regulating medical devices in the UK - April update
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. This is an extract...
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New FDA Guidance on Risk Management!
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational...
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Examples of Class III medical devices
Medical Device classification under MDR. Examples of MDR class III medical devices
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Best Practice Guidance for the Submission of EU Technical File and Documentation of Medical Devices
New guidance on EU Technical Documentation for medical devices
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Examples of Class IIb medical devices
Medical device classification examples. Class IIb under MDR rules.
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Examples of Class IIa medical devices
Medical device Class IIa examples
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Examples of EU Medical Device - Class I
Examples of medical devices classes
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Impact of extension of the MDR
The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the...
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Foods for special medical purposes/medical foods: A global regulatory synopsis
Foods for special medical purposes/medicinal foods have different regulations depending on where they are manufactured or sold.
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MDR and IVDR Delay!
Today, 6th January 2023, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of...
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EU Health Commissioner proposes MDR delay to prevent medical device shortages
The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years
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Border line products?
#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...
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UKCA Marking - extension of standstill period
The MHRA explained its intention to extend the standstill period of using the CE Mark by 12 months to 30 June 2024 for the medical devices.
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Medical Device User Fee Amendments (MDUFA)
User Fees for FY2023 Annual Establishment Registration Fee: $6,493 All establishments must pay the establishment registration fee. There...
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FDA NEWS: Electronic Submission Template for Medical Device 510(k) Submissions
This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s.
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UPDATED GUIDANCE MHRA
This guidance document replaces the previous MHRA guidance titled “medical device standalone
software, including apps”.
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