Reforms to software-based medical devices take effect this week | Hogan Lovells
[co-author: Angell Zhang] The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week, on 25 February 2021. What is the new regime? From 25 February 2021, the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 (Cth) (“Amendment Regs”) take effect. Broadly, the Amendment Regs introduce new classification r...
Source: jdsupra.com