Module 19 2021

01/06/2021

Considerations for the RCP Process

Gather data ● Define the Intended use ● Use standard formats ● Consider that Instruments and Tests are different ● Remember accessories, software etc Talk to regulators upfront ● E.g. US Pre-Sub Ensure you define requirements (early Regulatory plan) ● And keep monitoring Approval is not the end ● All parts need to be maintained

Gather Data vs

Submit

Review

Approval

Maintenance

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Considerations for maintenance

Products must be monitored in terms of performance at the manufacturer and with the customer ● Changes to labelling must be monitored closely Regular (annual?) updates or charging may be needed ● Resources? Significant change or cumulative change will likely require a resubmission

OUTCOMES

Registration Database

Reimbursement assessment

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