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- 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
[FDA] FDA/MDD Guideline; Classification product code
- Admin Hits:874
- 2014-07-08 19:10:00
FDA/MDD Guideline; Classification product code
2013.04.11일 US FDA는 FDA인증 허가를 준비하는 수입 및 제조업체가 규정에 맞게 당사의 의료기기를 분류할 수 있도록 가이드라인을 제공하고 있습니다.
FDA에서 의료기기(MDD)는 ‘21CFR Part 862-892’조에 걸쳐 총 16개의 의료파트로 분류하고 있으며, 각 파트는 다시 세부파트로 분류되고 있습니다.
FDA를 진행하시기 전 해당 제품이 16개의 의료파트 중 어디에 해당하는지 알 수 없거나 등급 및 분류가 확실하지 않은 업체에서는 FDA문서 준비 전 해당 가이드라인을 참조하시어 요구되는 규제에 알맞은 문서를 준비하시기 바랍니다.
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