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- Medical devices (122)
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1008 result(s) found, displaying 1 to 25
- GuidanceRegulation of software based medical devicesSoftware based medical devices are medical devices that incorporate software or are software.
- GuidanceNotifications process: requests to vary registered medicines where quality, safety and efficacy are not affectedOutlines types of variations that have been determined to pose a very low risk.
- GuidanceExport certification for medical devicesThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
- GuidanceMedical device patient information leaflets and implant cardsFrom 1 December 2021 all implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs) and Patient Implant Cards (PICs).
- GuidanceGuidance on applying the Advertising Code rulesAll advertising must comply with the 2021 Code rules from 1 July 2022.
- GuidanceApplication requirements for new substances in listed medicinesThis guidance is for applicants requesting evaluation of a substance for use in listed medicines [AUST L listed medicines and AUST L(A) assessed listed medicines].
- GuidanceRegulatory framework for personalised medical devices: Frequently asked questionsFrequently asked questions to further clarify the new regulatory framework for personalised medical devices
- GuidanceExport of human substancesHow to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
- GuidanceReclassification of active implantable medical devices (AIMD)This guidance is to assist sponsors comply with new regulations.
- Compositional guidelinesGalactooligosaccharidesCompositional guideline for 'Galactooligosaccharides' permitted for use in listed medicines
- GuidanceSerious Scarcity Substitution Instruments (SSSIs)Serious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
- GuidanceGuidance for requesting reconsideration of an initial decisionHow to request reconsideration of 'reviewable' initial decisions by the Minister for Health
- GuidanceLegal supply of COVID-19 test kitsUpdated information about the legal supply of COVID-19 test kits
- GuidanceGuidance on mushroom productsWhen mushroom products are likely to be considered foods or therapeutic goods under the Act.
- GuidanceTherapeutic goods advertising and ASX announcementsComplying with the advertising rules for therapeutic goods while meeting continuous disclosure obligations.
- FormsEssential principles checklist (medical devices)Medical devices - Essential principles checklist updated to include clauses relating to personalised medical devices and improve usability
- FormsSection 19A application form to import and supply substitute medicinesApply to import and supply substitute medicines under section 19A
- GuidanceMedicine Shortages in Australia: Reporting obligations and the TGA's compliance frameworkGuidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations of supply of mostly prescription medicines
- GuidanceMedicine shortages: Information for sponsors (suppliers)We have updated guidance on how to report medicine shortages to make the process clearer and easier to understand
- GuidanceReporting medicine shortages and discontinuations in Australia - Guidance for sponsorsWe have updated guidance on how to report medicine shortages to make the process clearer and easier to understand
- GuidanceSection 19A: Guidance for industryThe reference to the Quarantine Act 1908 in the Section 19A Guidance document has been replaced with reference to the Biosecurity Act 2015.
- Compositional guidelinesCalanus finmarchicus oilCompositional guideline for 'Calanus finmarchicus oil' permitted for use in listed medicines
- GuidanceChanges to the Permissible Ingredients DeterminationWe review the Permissible Ingredients Determination to ensure the ingredients are safe for use in low-risk medicines.
- FormsNotification of commencement of supplyA form for sponsors to notify the TGA of the date that they will commence marketing a product registered on the ARTG