Translated with AIOn April 1, 2026, Health Canada published the “Guidance on terms and conditions for class II to IV Medical [...]
Translated with AI On March 20, 2026, the European Commission adopted two delegated regulations, C (2026) 1809 and C (2026) 1798, [...]
Translated with AI In February 2026, the Medical Device Authority (MDA) published the 7th edition of the guidance document "Requirements for [...]
Translated with AIIn February 2026, the Australian Therapeutic Goods Administration (TGA) published version 2.0 of the official guide: "Complying with the [...]
On February 2, 2026, version 010 of the MDSAP AU P0002 – Audit Approach manual was released. This update comes nearly [...]
On February 2, 2026, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850. The comprehensive document serves as [...]
On 26 January 2026, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) launched [...]
Translated with AI The regulatory framework for medical device labelling in Thailand reached a comprehensive synthesis with the publication of the [...]
Translated with AI The evolution of digital health has blurred the lines between IT tools and Medical Devices. A key reference [...]
Translated with AI With the publication of the proposal for a Regulation COM(2025) 1023 final of 16 December 2025, the European [...]
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