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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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FDA Rule Change Sees Laboratory Developed Tests Regulated as Medical Devices
"Learn how the FDA's new rule classifying Laboratory Developed Tests as medical devices impacts healthcare, and how AF Pharma can help you
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Israel's AMAR Regulatory Changes for Medical Devices: A Leap Towards Streamlined Approvals
Discover Israel's new medical device regulations - AMAR system simplifies approvals, expands reference countries, and fosters innovation
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Real World Data - FDA Guidelines
Real-world data, as per FDA guidelines, plays a pivotal role in enhancing drug safety and effectiveness assessments, informing healthcare.
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MHRA Decision Aid: MDR Extended Transitional Period Coverage Assessment
MHRA generated a flowchart to assist in deciding whether or not a medical device is covered by the extended MDR transitional period.
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FDA - Medical Device Establishment Registration: 2024 fees
2024 MDUFA fees. The new Medical Device Establishment Registration for 2024 is $7,593.00.
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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.
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UK's Software and AI as a Medical Device Change Programme
In today's technologically driven world, software, including Artificial Intelligence (AI), is revolutionizing various industries,...
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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...
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Title: AF Pharma: Your Trusted FDA US Agent Partner for Global Market Access
US Agent and FDA support
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Medical Device Development with MDDT Qualification
FDA GUIDANCE: Qualification of Medical Device Development Tools Guidance for Industry, Tool Developers, and FDA documents.
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MHRA - Template Letter for EU Article 120 Extension Confirmation
MHRA Updates Guidance and Template Letter for EU Article 120 Extension Confirmation
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Legacy Devices with Expired Certificates
MDCG 2022-18 position paper on Article 97 MDR for expired MDD/AIMDD certificates is now irrelevant due to new regulations (EU) 2023/607.
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Import Medical Devices to Brazil
Importing medical devices to Brazil involves following specific procedures and adhering to regulatory requirements set forth by ANVISA.
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Medical Device Technical File Generation
AF Pharma offers experience and expertise to simplify the process of technical file generation, ensuring regulatory compliance.
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A Guide to Finding GMDN Codes for Free - UKRP
If you work in the medical device industry, you may be familiar with the Global Medical Device Nomenclature (GMDN) system. GMDN codes are...
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Simplify Your Medical Device EU Technical File with AF Pharma Consulting
Are you a medical device manufacturer looking to enter the European Union (EU) market? Navigating the complex regulatory landscape can be...
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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.
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💊💊 BREAKING PHARMA NEWS- MHRA Medicines and future Medical devices updates! 💉💉
MHRA has just announced new regulatory recognition routes for MEDICINES.
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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
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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...
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