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Nov 32 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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Oct 142 min read

MDCG Med. Dev Guidance: Qualification of In Vitro Diagnostic Medical Devices (IVDs)

The Medical Device Coordination Group (MDCG) has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...

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Jul 102 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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May 12 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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Mar 302 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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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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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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