Module 17 2024

05/12/2024

• For devices from Australia, the validity of the Certificate of International Reliance would be in accordance with the TGA conformity assessment certification. • Subsequent to the international recognition of EU medical devices during the transitional arrangements period, for devices from the EU, the validity of the Certificate of International Reliance would be in accordance with the EU MDR or IVDR certification. • For devices from Canada or the USA, the validity of the Certificate of International Reliance would be in accordance with the QMS (for example, the Medical Device Single Audit Program (MDSAP) or accredited ISO 13485) certification. • Following the device's registration, the MHRA may suspend or cancel the Certificate of International Reliance if we believe that any of the requirements for market access are not met. Chapter 14: Alternative Routes to Market

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Chapter 14: Alternative Routes to Market

• The manufacturer must keep the information provided during the review process for the longer of – a) the lifetime of the device; b) 15 years for implantable devices or 10 years for any other devices. • If a significant change is made to the device, the manufacturer must submit a new application for international reliance unless the device is software as a medical device and has a predetermined change control plan . • The proposed framework would have a transition period of 12 months.

The Organisation for Professionals in Regulatory Affairs

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