GN-10-R3.1 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2019)

Name: GN-10-R3.1 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2019)
Creator: Health Sciences Authority
Keywords: actions,corrections,declarations,field-safety-corrective-action,fsca,guidances,medical-devices,safety,templates,updates

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Field Safety Corrective Action (FSCA)

Last updated

January 1, 2019

Description

Provides guidance on Medical Device Field Safety Corrective Action (FSCA).

Organization

Health Sciences Authority (HSA) 🇸🇬

Country / Region

Singapore

License

Other (Public Domain)

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2 Main files

GN-10-R3.1 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2019)

Updated on January 1, 2019

pdf (666.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-10-r3-6-guidance-on-medical-device-field-safety-corrective-action(20jan-pub).pdf?sfvrsn=fca4655a_2
Permalink: https://data.openrid.co/en/datasets/r/da0c0d22-e439-4ebf-be19-ea1c2997792b
MIME Type: application/pdf

Created on: March 17, 2024
Modified on: January 1, 2019

Size: 666.0KB

GN-10 Annex 1 Declaration on Completion of Correction Template (Updated on August 2018)

Updated on August 1, 2018

doc (97.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/medical-devices/gn-10-annex-1(18aug).doc?sfvrsn=b1ef3467_2
Permalink: https://data.openrid.co/en/datasets/r/6cbb8776-5efa-43b7-9364-9360339b1391
MIME Type: application/msword

Created on: March 17, 2024
Modified on: August 1, 2018

Size: 97.0KB

GN-10-R3.1 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2019)

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Regulated products

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Last updated

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