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Oct 272 min read

MDCG Guidance: MDR requirements for Legacy Devices

The Medical Device Coordination Group (MDCG) has released guidance " Application of MDR requirements to ‘legacy devices’ and to devices...

Jun 52 min read

India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines

The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...

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...

Dec 30, 20231 min read

Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices

The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical...

Nov 15, 20232 min read

Switzerland's SwissMedic: Guidance on Formal Requirements

On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...

Jul 2, 20231 min read

Health Canada: Guidance on Master Files Procedures & Administrative Requirements

Health Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for...

May 21, 20231 min read

Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)

Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...

Dec 27, 20222 min read

SFDA MD Guidance: Requirements for Clinical Trials of Medical Device

Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...