News

On May 25, 2026, the US FDA updated its database of recognized consensus standards (Recognition No 2-313), partially adopting the sixth [...]

On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable fillers, [...]

In recent months, the regulatory framework governing the biological safety of Medical Devices has undergone a significant evolution. With the [...]

On 5 May 2026, Commission Implementing Regulation (EU) 2026/977 was published, introducing a harmonised framework of quality and procedural requirements [...]

Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant interpretative [...]

Translated with AI. On 1 April 2026, the European Commission published the Article 10a Decision Tree and Revision 2 of the [...]

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 [...]