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Home » TGA Issues Guidance on Applying for Consent for Noncompliance with Essential Principles
TGA Issues Guidance on Applying for Consent for Noncompliance with Essential Principles
Australia’s Therapeutic Goods Administration (TGA) has offered advice to devicemakers in a new guidance about how to apply for consent to import, supply or export a medical device that doesn’t comply with the agency’s Essential Principles for safety and performance.