In September 2023, Berlin hosted the 24th IMDRF Management Committee meeting, chaired by the EU and attended by over 550 global participants over five days, revealing significant developments in medical device regulation. IMDRF/DITTA-GMTA Joint Workshop (25 September 2023): Explored tailored medical devices (MDs) for specific patient demographics (e.g., orphan, humanitarian, paediatric, custom MDs). Examined innovative MDs, their global regulatory pathways, and potential international collaboration. Introduced regulatory toolboxes for innovation, including regulatory sandboxes and predetermined change control plans (PCCPs). IMDRF Stakeholder Forum (26 September 2023): Shared regulatory updates from IMDRF MC Members and......
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Introduction The TGA’s August 2023 guidance focuses on requirements for active medical devices, which are defined as devices that significantly convert energy to operate. This excludes devices operated by gravity or human effort. The guidance clarifies classification rules, essential principles, and different types of energy like chemical and elastic energy. Electromedical Safety Standards Electromedical devices like pacemakers pose safety risks. Manufacturers must comply with Essential Principles 9.2 and 12. They can either follow Australian or international standards like IEC 60601-1 or justify alternative compliance methods. Connection to Public Mains Devices that connect......
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The Therapeutic Goods Advertising Code (the Code) sets out the rules which govern advertisement of therapeutic goods to Australian consumers. This regulatory framework made under section 42BAA of the Therapeutic Goods Act 1989 (the Act) is intended to ensure advertisements: promote the safe and proper use of therapeutic goods by minimising misuse, overuse or underuse; and are ethical and do not mislead or deceive the consumer or create unrealistic expectations about the product performance of the therapeutic goods; and support informed health care choices; and are not inconsistent with current health campaigns. On 01......
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