The Therapeutics Goods Administration (TGA) has established a transition period to facilitate smooth transitions and allows continued manufacture and supply of Patient-Matched Medical Devices (PMMDs) under the exemption until 1 July 2029. Patient-Matched Medical Devices (PMMDs) now meet the previous definition of a custom-made medical device.
Key Deadlines for PMMDs
1) Notification to the TGA:
If you intend to continue supplying PMMDs on or after 1 July 2029, you must notify TGA of your intent to transition by 1 November 2024.
2) ARTG Inclusion Requirement Post-2029:
After 1 July 2029, all PMMDs must:
Be included in the Australian Register of Therapeutic Goods (ARTG), or,
Have a valid application for inclusion under review
Continuing Exemptions Until 2029
According to the Therapeutic Goods (Medical Device) Regulations 2002, PMMDs will remain exempt from ARTG inclusion until the end of the transition period to ensure manufacturers and suppliers can maintain operations while adapting to the new requirements.
Patient-Matched Medical Devices:
Defined by TGA as set out in the Regulations, PMMD is a specifically designed and manufactured medical device to meet the unique needs of an individual, either by aligning with their anatomical and physiological features or addressing a specific pathological condition.
These devices are created within a defined design envelope by the manufacturer, often in consultation with healthcare professionals, ensuring a tailored approach to care. The manufacturing processes used are rigorously validated, verified, and reproducible, ensuring consistent quality and performance for each device.
Next Steps for Stakeholders
To ensure compliance and uninterrupted supply:
Review your products to identify devices transitioning from custom-made to PMMD classifications.
Notify TGA before the 1 November 2024 deadline if you intend to supply PMMDs post-2029.
Prepare for ARTG inclusion by aligning with the TGA requirements for patient-matched devices.
These changes aim to enhance the regulatory oversight of PMMDs, ensuring they meet safety and efficacy standards while accommodating advancements in personalized medical technology.
For further guidance, you are welcome to connect with our regulatory experts to navigate this transition effectively.
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