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 [...]
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 [...]
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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