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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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AU Sponsor
AF Pharma is now your trusted Australian Sponsor, ensuring TGA compliance, ARTG registration, and seamless market access for your products!
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EC Rep
Appointing an EU Authorized Rep is vital for non-EU manufacturers. AF Pharma ensures compliance, documentation, and seamless EU market!
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Cosmetic registration
EU cosmetic compliance ensures safety, quality, and trust. AF Pharma guides brands through regulations, from safety assessments to market.
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GPSR Registration
GPSR ensures EU product safety with stricter risk, traceability, and surveillance rules. AF Pharma offers expert support!
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GPSR Services
A Canadian electronics company expanded into the EU market with AF Pharma's GPSR services, boosting Amazon sales by 40% within six months.
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GPSR Responsible Person
AF Pharma’s EU Responsible Person services ensure compliance with GPSR, helping businesses navigate EU regulations and maintain market.
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AF Pharma’s UKRP Services for Norway
AF Pharma’s UKRP services helped a Norwegian medical device company enter the UK market swiftly, boosting UK sales by 35%
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GPSR
AF Pharma offers EU Responsible Person services to ensure compliance with the GPSR, helping businesses navigate EU regulations.
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EC Rep Now
AF Pharma’s EU Authorized Representative (EC Rep) services help non-EU medical device manufacturers.
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EUDAMED Nov 24
EUDAMED's phased roll-out under EU MDR/IVDR enhances device transparency, safety, and compliance. Prepare now for mandatory module use!
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UKRP Services Helped a US Company
AF Pharma’s UKRP services helped a US medical device company achieve rapid UK market entry, boosting sales and ensuring full MHRA compliance
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MOCRA: FDA's New Cosmetic Regulation
MOCRA updates U.S. cosmetic laws, requiring FDA registration, GMP compliance, adverse event reporting, and safety substantiation for product
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UKRP Services for Medical Devices
AF Pharma’s UKRP services for medical devices simplify UK compliance, enabling fast, reliable market access and growth in the UK.
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TGA to Accept FDA 510(k)
Devices supported by 510(k) clearances (unlike those with PMA approvals) must undergo a mandatory TGA application audit
Soledad
Cybersecurity in Medical Devices
Regulatory for Software as medical device (SaMD)
Soledad
The PRRC
the introduction of the Person Responsible for Regulatory Compliance (PRRC)Â is one of the most significant changes for the MDR
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UKRP for Medical Devices
AF Pharma’s UKRP for medical devices helps EU companies navigate UK compliance, boosting market entry and growth for manufacturers across EU
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MDR revision
Medical Devices Regulation - MDR Revision: European Parliament Takes Action. Medical Devices Regulation (MDR) (2024/2849(RSP))
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Artificial Intelligence - AI in Medical Devices
As Artificial Intelligence - AI in Medical Devices continues to revolutionize industries across the globe
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PMS UK Requirements
Post-market Surveillance (PMS) Statutory Instrument: The Future of Medical Device Regulations in Great Britain.
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