GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB

Name: GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB
Creator: Health Sciences Authority
Keywords: checklists,guidances,medical-devices,performance,principles,safety,templates

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Essential Principles For Safety And Performance

Last updated

September 1, 2023

Description

Provides guidance on essential principles for safety and performance of medical devices.

Organization

Health Sciences Authority (HSA) 🇸🇬

Country / Region

Singapore

License

Other (Public Domain)

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3 Main files

GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB

Updated on September 1, 2023

pdf (331.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-16-r4-guidance-on-essential-principles-for-safety-and-performance-of-medical-devices(2023-sep)-pub.pdf?sfvrsn=88fbb855_2
Permalink: https://data.openrid.co/en/datasets/r/3bec3913-ae6c-4062-8439-aa0a0831293b
MIME Type: application/pdf

Created on: March 17, 2024
Modified on: September 1, 2023

Size: 331.0KB

Annex 2 GN-16 R4 Essential Principles Checklist Template (June 2018 version)

Updated on June 1, 2018

doc (172.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-gn-16-r4-essential-principles-checklist-template-(june-2018-version).doc?sfvrsn=ef91caca_2
Permalink: https://data.openrid.co/en/datasets/r/8c83a6ea-9b2a-492c-9975-951af26ec782
MIME Type: application/msword

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

Size: 172.0KB

Annex 3 GN-16 R4 Essential Principles Checklist Template (Dec 2017 version)

Updated on December 1, 2017

doc (128.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-3-gn-16-r4-essential-principles-checklist-template-(dec-2017-version).doc?sfvrsn=f0eb97e8_2
Permalink: https://data.openrid.co/en/datasets/r/8009baab-3fd4-4a86-91ef-7a22028773ab
MIME Type: application/msword

Created on: March 17, 2024
Modified on: December 1, 2017

Size: 128.0KB

GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB

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