Gn-23 Guidance On Labelling For Medical Devices

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HSA | Guidance documents for medical devices

https://www.hsa.gov.sg/medical-devices/guidance-documents

Grouping of medical devices . GN-12-1-R2.1 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on November 2017) 616 KB; GN-12-2-R2 Guidance on Grouping-Specific (2022 Jan) PUB …

Revision 1 - hsa.gov.sg

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-23-r1-1-guidance-on-labelling-for-medical-devices(20mar-pub).pdf

MEDICAL DEVICE GUIDANCE MARCH 2020 _____ HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 4 of 18 1. INTRODUCTION 1.1. …

Guidance on Medical Device Patient Labeling | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling

Center for Devices and Radiological Health This guidance serves a dual purpose: (1) to assist manufacturers in their development, and (2) to assist Center reviewers in their …

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Guidance on Medical Device Patient Labeling - Final Guidance for Industry and FDA Staff (PDF - 333KB) Section 206 of the Medical Device User Fee and …

Guidance Document: Guidance for the Labelling of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html

Each device including a system, medical device group, medical device family, or medical device group family must have a name. The device licence is issued for (a) the …

HSA Guidance on Labeling for Medical Devices: …

https://www.regdesk.co/hsa-guidance-on-labeling-for-medical-devices-introduction/

HSA Guidance on Labeling for Medical Devices: Introduction Jan 23, 2022 The first article describes the regulatory background for labeling requirements, provides …

Medical Device Administrative Control System …

https://www.mdd.gov.hk/filemanager/common/mdacs/GN-03-E.pdf

the device labelling 3.1.2 Filter removed and intentionally not replaced despite clear warnings inthe device labelling, resulting in particulate contamination and subsequent …

SINGAPORE: HSA Released Guidance on Medical Device …

https://www.qualtechs.com/en-gb/singapore--hsa-intends-to-introduce-udi-system-for-medical-devices-–-july-2021

This is a supplemental guideline to other guidance documents that were published beforehand. This includes, but is not limited to, GN – 15, GN – 21, and GN – …

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