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Sharan Murugan
Mar 12 min read
SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA)Â has released an updated " Guideline for the Classification of Medical...
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Sharan Murugan
Feb 182 min read
Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â oversees the regulation and registration of medical devices within the...
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Sharan Murugan
Nov 3, 20242 min read
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...
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Sharan Murugan
Oct 14, 20242 min read
MDCG Med. Dev Guidance: Qualification of In Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG) Â has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...
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Sharan Murugan
Jul 10, 20242 min read
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...
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Sharan Murugan
May 1, 20242 min read
Australia TGA: Regulatory requirements for in-house IVDs
Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...
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Sharan Murugan
Mar 30, 20242 min read
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...
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Sharan Murugan
Aug 21, 20221 min read
Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...
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Sharan Murugan
Sep 17, 20211 min read
South Africa- Updated Guideline on Classification of Med.Dev and IVDs & Medicines for use in PHU
Updated Guideline on Classification Of Medical Devices and IVDs The aim of this guideline is to assist manufacturers, importers,...
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