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USFDA Guidance: UDI Requirements for Combination Products and Cybersecurity for Medical Devices
In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...

Sharan Murugan
Jun 293 min read
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USFDA Guidance: Application User Fees for Combination Products
The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...

Sharan Murugan
Jul 16, 20242 min read
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EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies
The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...

Sharan Murugan
May 25, 20242 min read
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Australia TGA: Regulation of Software based Medical Devices
On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...

Sharan Murugan
May 14, 20242 min read
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South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products
Earlier today (07-February-2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for...

Sharan Murugan
Feb 7, 20231 min read
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USFDA Guidance on Premarket Review of Combination Products
US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...

Sharan Murugan
Feb 6, 20221 min read
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