Regulatory Blog

As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become...

The Medical Device Coordination Group (MDCG) has released the 2020-16 rev.4 guidance document, " Guidance on Classification Rules for in...

The South African Health Products Regulatory Authority (SAHPRA) has released an updated " Guideline for the Classification of Medical...

The Medicines and Healthcare Products Regulatory Agency (MHRA)  oversees the regulation and registration of medical devices within the...

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...

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

WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...

Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...

Updated Guideline on Classification Of Medical Devices and IVDs The aim of this guideline is to assist manufacturers, importers,...