Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices

Name: Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices
Creator: Ministry of Food and Drug Safety
Keywords: assessment,conformity-assessment,considerations,diagnostics,guidances,medical-devices,regulations,support

Information

Original link

Type

Regulation

Regulated products

IVDMD, Medical Devices

Published

March 29, 2024

Last updated

March 29, 2024

Description

Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices

Organization

Ministry of Food and Drug Safety (MFDS) 🇰🇷

Country / Region

South Korea

License

Other (Public Domain)

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1 Main file

Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices (Final Document)

Updated on March 29, 2024

pdf

URL: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72635&data_tp=A&file_seq=1
Permalink: https://data.openrid.co/en/datasets/r/e609d649-e9af-4338-bd88-1ed6b169b757
MIME Type: application/pdf

Created on: March 29, 2024
Modified on: March 29, 2024

Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices

Information

Type

Regulated products

Published

Last updated

Description

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Country / Region

License

Feedback

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