Tag: regulatory compliance


Highlights from the 24th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Berlin, Germany

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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Summary of the TGA’s Guidance Document for Active Medical Devices

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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Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices

What is a valid ISO 13485 QMS certificate accepted by the TGA? International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The TGA accepts ISO 13485 certificates issued by Notified Bodies or an International Accreditation Forum (IAF) certified conformity assessment body. Refer to the Table provided below for a summary of TGA accepted manufacturer’s evidence for IVD medical devices.   What is changing? The COVID-19 pandemic had a significant impact on the IVD industry which was burdened with......

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The Importance of Risk Management

Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local regulatory authorities. Effective risk management is essential for determining whether the benefits of the product outweigh any potential risk to the patient. ISO 14971 ’Medical devices – Application of risk management to medical devices’ is the international standard for the application of risk management by a manufacturer to medical devices, including in vitro diagnostics (IVD’s). ISO 14971 is accepted by the TGA......

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