GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB

Name: GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB
Creator: Health Sciences Authority
Keywords: guidances,guide,imdrf,in-vitro-diagnostics,ivd,registrations,submissions

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Product Registration Dossier Requirements

Last updated

March 1, 2024

Description

Guidance document on preparing a product registration submission for IVD MD using ASEAN CSDT.

Organization

Health Sciences Authority (HSA) 🇸🇬

Country / Region

Singapore

License

Other (Public Domain)

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3 Main files

GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB

Updated on March 1, 2024

pdf (1.5MB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-18-r3-guidance-on-preparation-of-a-product-registration-submission-for-ivd-md-using-the-asean-csdt-(2024-mar)-pub.pdf?sfvrsn=1eac010b_4
Permalink: https://data.openrid.co/en/datasets/r/324d21f3-befb-4227-920a-2626d5704ad8
MIME Type: application/pdf

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

Size: 1.5MB

E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3 (2024 Mar) PUB

Updated on March 1, 2024

pdf (404.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/e-submission-guide-for-ivd-md-for-asean-csdt-and-imdrf-toc-based-submissions-in-medics-r3-(2024-mar)-pub.pdf?sfvrsn=c9f695c_2
Permalink: https://data.openrid.co/en/datasets/r/a57b539b-2f1e-44a9-85cb-63e707e4f404
MIME Type: application/pdf

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

Size: 404.0KB

Annex 2 for GN-17 and GN18 List of Configurations (2024 Mar)

Updated on March 1, 2024

xls (49.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-for-gn-17-and-gn18-list-of-configurations-(2024-mar).xlsx?sfvrsn=2f59badc_2
Permalink: https://data.openrid.co/en/datasets/r/90f797f8-39db-4d6c-b3ac-102212397574
MIME Type: application/vnd.ms-excel

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

Size: 49.0KB

GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB

Information

Type

Regulated products

Topics

Last updated

Description

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Country / Region

License

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