US FDA Medical Device Establishment Registration
US FDA Medical Device Establishment Registration is the process where medical devices facilities are registered in the US FDA.
top of page
Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing.
Search
pharmaserviceinc
Draft UK Post-market Surveillance Requirements
We have some exciting news to share regarding the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has recently...
Soledad
Medical Device Technical File Generation
AF Pharma offers experience and expertise to simplify the process of technical file generation, ensuring regulatory compliance.
Soledad
New Draft Compromise Amendments for AI in the EU
A new Draft Compromise Amendments for AI in the EU has been published and you can download it below. Also, AF Pharma can help you.
pharmaserviceinc
Regulatory Landscape for Custom-Made Medical Devices in the EU
Navigating the complex regulatory landscape of the European Union (EU) can be overwhelming when seeking compliance, registration, and succes
Soledad
MHRA Updated Guidance on Software: Understanding Medical Device Status and Regulation
In the ever-evolving field of medical devices, software applications (apps) are playing an increasingly significant role. To ensure the...
Soledad
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.
Soledad
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.
Soledad
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...
Soledad
Examples of Class III medical devices
Medical Device classification under MDR. Examples of MDR class III medical devices
Soledad
Examples of Class IIb medical devices
Medical device classification examples. Class IIb under MDR rules.
Soledad
Examples of Class IIa medical devices
Medical device Class IIa examples
Soledad
Examples of EU Medical Device - Class I
Examples of medical devices classes
pharmaserviceinc
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...
Soledad
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...
Soledad
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
Soledad
Border line products?
#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...
Soledad
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.
Soledad
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...
-
UPDATED GUIDANCE MHRA
This guidance document replaces the previous MHRA guidance titled “medical device standalone
software, including apps”.
bottom of page