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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
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- ISO 37001 Anti-bribery Management
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ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
icmcert@naver.com
+82-2-851-3111
Medical Devices FDA
[FDA] 코로나로 인한 체온계 인증
- Admin Hits:570
- 2020-05-29 20:01:00
안녕하세요
ICMC 해외인증경영센터 FDA 담당자 입니다.
체온계는 Class II Device이기 때문에 반드시 510k 받으셔야 합니다.
코로나 때문에 한시적으로 가이드라인에 규정된 시험이 되어있고 라벨링이 되어있다면 미국으로 수출가능합니다.
그러나 긴급 승인 기간이 끝나면 정식으로 510k 허가를 받으셔야 합니다.
자세한 사항은 첨부 가이드라인을 참고하시기 바랍니다.
감사합니다.
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