Medical Services

UL's step-by-step regulatory process

STEP 5: Issuance of Certifications, or recommendations to regulators

• Close Action Requests, and Non-Conformances
• UL Notified Body Reviews all the final reports (for CE only)
• Issuance of CE and/or QMS certification
• Send Substantial Equivalence recommendation to the FDA
• Send Technical file and Audit reports to Brazil

Other steps

• Forward to step 6
• Back to step 4
• Back to all steps