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MDCG Med Dev: Guidance on Classification Rules for In-Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG)Â has released the 2020-16 rev.4Â guidance document, " Guidance on Classification Rules for in...
Sharan Murugan
5 days ago2 min read
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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...
Sharan Murugan
Mar 12 min read
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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...
Sharan Murugan
Feb 182 min read
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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...
Sharan Murugan
Nov 3, 20242 min read
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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...
Sharan Murugan
Oct 14, 20242 min read
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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...
Sharan Murugan
Jul 10, 20242 min read
17 views
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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...
Sharan Murugan
May 1, 20242 min read
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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...
Sharan Murugan
Mar 30, 20242 min read
61 views
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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...
Sharan Murugan
Aug 21, 20221 min read
602 views
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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,...
Sharan Murugan
Sep 17, 20211 min read
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