Translated with AI On November 19, 2025, the Therapeutic Goods Administration (TGA) released the updated guidance "Complying with the Essential [...]
Translated with AI On December 16, 2025, the European Commission published the new guidance MDCG 2025-9 on “Breakthrough Devices (BtX)”. The [...]
Translated with AI On November 27, 2025, the European Commission announced the full functionality of four out of the six [...]
From EU regulation (MDR/IVDR) to the specific Italian Guidelines of 2025: this white paper covers the fundamental principles and rules [...]
The new Quality Management System Regulation (QMSR) comes into effect on February 2, 2026, following the publication of the Final Rule [...]
Translated with AI After eleven years, the National Medical Products Administration (NMPA) published the new edition of Good Manufacturing Practices (GMP) [...]
Translated with AI On November 8, 2025, Health Canada (HC) launched a public consultation on the proposed modernization of the Medical [...]
Translated with AI On October 23, 2025, the Spanish Royal Decree No. 942/2025 was published in the Boletín Oficial del [...]
This white paper summarizes the key contents and highlights from the morning roundtables of MDG 2025 – MedGenerAction which took place in Bologna on October 1st, 2025. MDG is the annual reference summit for professionals operating in the Medical Device sector, presented by Complife Group.
Translated with AI Interesting incentives continue for medical device manufacturers interested in expanding into the Asian market. In September 2025, [...]
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