Person Responsible for Regulatory Compliance (PRRC)
✿ Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
✿Authorized representatives shall have atleast 1 PRRC, permanently and continuously at their disposal
✿ The requisite expertise shall be demonstrated by both by certain formal Educational qualifications and professional experience in the Regulatory Affairs or in the QMS
✿ Micro and small enterprises shall have such person permanently and continuously at their disposal.
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