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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...

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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...

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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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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...

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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...

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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...

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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...

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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...

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