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- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
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- ICMC NEWS & LIBRARY
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- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
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ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
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Medical Devices FDA
[FDA] 510(k) Submission Process
- Admin Hits:822
- 2018-02-02 19:34:00
FDA의 510(k) Submission Process 입니다.
Class Ⅰ device보다 위험도가 높은 의료기기를 Class 2Ⅱ device 로 지정했으며,
Class Ⅱdevice의 Submission은 시판전 신고라는 Pre-market Notification 절차를
거쳐야 하며 이를 통상적으로 510(k)라고 부릅니다.
하기 링크를 따라 510(k) Submission Process 를 확인해 보시기 바랍니다.
)
<링크(출처) : http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm> |
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