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Sharan Murugan
- Dec 3, 2023
- 1 min
UK MHRA: Guidance on Register Medical Devices to Place on the Market
Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...
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Sharan Murugan
- Nov 26, 2023
- 2 min
Australia TGA: Clinical Evidence Guidelines
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...
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Sharan Murugan
- Nov 26, 2023
- 2 min
Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
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Sharan Murugan
- Nov 19, 2023
- 1 min
South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...
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Sharan Murugan
- Nov 19, 2023
- 2 min
USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...
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