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5 days ago

Thailand: Guidelines for Document Referencing, Transfers, & Compliance in Medical Device Applications (w.e.f. 20 September 2024)

In alignment with the guidelines for licensing requests or notifications of medical device details by individuals, entities, or...

Nov 13

Nigeria: Zero VAT on Pharmaceuticals and Medical Devices

On the 9 October 2024, the Nigerian Federal Ministry of Health and Social Welfare has finalized an Executive Order implementing zero...

Nov 12

Indonesia: New Requirements for Medical Device Distributors Licensing Compliance (w.e.f 1 January 2025)

The Ministry of Health of Indonesia has introduced new guidelines for medical device distributors to enhance regulatory compliance,...

Nov 6

Belgium: Reminder End of Transition Period & Important Year-End Deadlines for Submitting Dossiers to the FAMHP

End of Transition Period for Clinical Trials FAHMP reminds all stakeholders, that starting from 31 January 2025 , all clinical trials...

Nov 5

Switzerland: Swissmedic Enhances Fast-Track and Temporary Authorization Processes for Human Medicine (w.e.f 15 Oct 2024)

Swissmedic, the Swiss regulatory authority for therapeutic products, has introduced updates to its guidance documents for the Fast-track...

Oct 30

New Zealand: Rollout New Life Changing Medicines for Public Health (w.e.f 1 October 2024)

In a significant advancement in healthcare, Pharmac, Te Aho o Te Kahu | Cancer Control Agency, Ministry of Health and Health New Zealand...

Oct 29

US: FDA’s DSCSA Exemptions, Waiver, & Exception

FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...

Oct 22

Australia: Critical Challenge for Medical Devices Due to 3G Network Shutdown

Starting on 28 October 2024 , both Telstra and Optus will be shutting down their third-generation (3G) networks. This follows the earlier...

Oct 17

Singapore: Cybersecurity Labelling Scheme Presents a New Standard for Medical Devices

On 16 October 2024, the Cybersecurity Labelling Scheme for Medical Devices (CLS [MD]) was officially launched, following a successful...

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