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, [...]
Translated with AI In September 2025, the Borderline and Classification Working Group (BCWG), an advisory group established by the European [...]
Translated with AI On September 5, 2025, the MHRA (Medicines and Healthcare products Regulatory Agency) published new guidelines and a [...]
Translated with AI Regulatory cooperation initiatives are intensifying in East and Southeast Asia, aiming to streamline medical device evaluation processes [...]
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