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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...

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...

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...

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...

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...

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...

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,...