Differences Between Certification and Approval | Proper Use of Registered Certification Bodies (RCBs) and PMDA

Meta Information

• title: Differences Between Certification and Approval | Proper Use of Registered Certification Bodies (RCBs) and PMDA | MK Consulting
• meta description: A pharmaceutical affairs consultant explains the differences between third-party certification and ministerial approval for medical devices. This article organizes the presence/absence of certification standards, the proper use of Registered Certification Bodies (RCBs) and PMDA, practical considerations when selecting a certification route, and cases ineligible for certification, based on official documents.
• Target Keywords: Medical device certification approval differences / Registered Certification Body / RCB / Third-party certification / PMDA approval

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For pharmaceutical affairs applications of medical devices, one of the following procedures is required, depending on the product's risk classification and conformity to certification standards: "Notification of Marketing Authorization," "Third-Party Certification by a Registered Certification Body (RCB)," or "Minister of Health, Labour and Welfare Approval (PMDA Review)."

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