GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB

Name: GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB
Creator: Health Sciences Authority
Keywords: class-a,declaration-of-conformity,declarations,doc,exemptions,guidances,importers,licensing,manufacturers,medical-devices,qms,quality-management-system,requirements

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Manufacturers, Importers And Wholesalers Licensing

Last updated

July 1, 2023

Description

Covers licensing requirements for manufacturers, importers and wholesalers of medical devices.

Organization

Health Sciences Authority (HSA) 🇸🇬

Country / Region

Singapore

License

Other (Public Domain)

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4 Main files

GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB

Updated on July 1, 2023

pdf (403.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-guidance-on-licensing-of-manufacturers-importers-and-wholesalers-of-md-(2023-jul)-pub.pdf?sfvrsn=e2d39d54_2
Permalink: https://data.openrid.co/en/datasets/r/ea8e3f51-f06f-44b7-adaf-681d7bf7bbd4
MIME Type: application/pdf

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

Size: 403.0KB

GN-02-R5 Annex 1 Declaration for Exemption from GDPMDS (2023 Jul)

Updated on July 1, 2023

doc (39.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-annex-1-declaration-for-exemption-from-gdpmds-(2023-jul).docx?sfvrsn=ff6e81c_2
Permalink: https://data.openrid.co/en/datasets/r/21ee8b72-9d6b-4110-bdb5-300c5ac24bdd
MIME Type: application/msword

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

Size: 39.0KB

GN-02-R5 Annex 5 Declaration of Conformity to a QMS (2023 Jul)

Updated on July 1, 2023

doc (39.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-annex-5-declaration-of-conformity-to-a-qms-(2023-jul).docx?sfvrsn=66bcb64d_2
Permalink: https://data.openrid.co/en/datasets/r/85233498-6ed5-4683-9873-e39129f5681d
MIME Type: application/msword

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

Size: 39.0KB

GN-02-R5 Annex 6 Declaration of Non-Dealing of Class A Medical Devices (2023 Jul)

Updated on July 1, 2023

doc (33.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-annex-6-declaration-of-non-dealing-of-class-a-medical-devices-(2023-jul).docx?sfvrsn=964b06d0_2
Permalink: https://data.openrid.co/en/datasets/r/aeb9f52d-d13b-4f2d-8e82-4606349c7e07
MIME Type: application/msword

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

Size: 33.0KB

GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB

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