Medical device conformity assessment application

Name: Medical device conformity assessment application
Creator: Therapeutic Goods Administration
Keywords: applications,assessment,certificates,certification,conformity-assessment,data,forms,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,manufacturers,medical-devices,support,tga

Information

Original link

Type

Form

Regulated products

Medical Devices

Topics

TGA Conformity Assessment Certification

Published

August 6, 2024

Last updated

August 6, 2024

Description

Information and forms about applications for TGA conformity assessment certificates.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

13 Main files

Conformity assessment certification - supporting data form – recertification for MDs including IVDs

Updated on August 6, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2024-08/conformity-assessment-certification-supporting-data-form.pdf
Permalink: https://data.openrid.co/en/datasets/r/ed8a876f-a1ad-4134-a149-080d8b8f7239
MIME Type: application/pdf

Created on: August 6, 2024
Modified on: August 6, 2024

Conformity assessment certification - supporting data form – recertification for MDs including IVDs

Updated on August 6, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2024-08/conformity-assessment-certification-supporting-data-form.docx
Permalink: https://data.openrid.co/en/datasets/r/ec5cac03-c090-47cd-8533-0efbcf3eb0f4
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 6, 2024
Modified on: August 6, 2024

Conformity assessment certification - supporting data form – Recertification

Updated on August 6, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-08/conformity-assessment-recertification.pdf
Permalink: https://data.openrid.co/en/datasets/r/fb70be9c-8ff9-48c0-a655-8ad0e3bd3791
MIME Type: application/pdf

Created on: August 6, 2024
Modified on: August 6, 2024

Conformity assessment certification - supporting data form – Recertification

Updated on August 6, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/2023-08/conformity-assessment-recertification.docx
Permalink: https://data.openrid.co/en/datasets/r/c758ff68-8286-4884-a5b0-9e5550d72e58
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 6, 2024
Modified on: August 6, 2024

Conformity assessment certification - Supporting data form: Additional section 3.3 (manufacturer facility details)

Updated on August 6, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/manuf-forms-conformity-assessment-certificates-s3-3-140804.pdf
Permalink: https://data.openrid.co/en/datasets/r/1bc8bcd8-1028-4d2f-b9d2-a5461d0c38f4
MIME Type: application/pdf

Created on: August 6, 2024
Modified on: August 6, 2024

Conformity assessment certification - Supporting data form: Additional section 3.3 (manufacturer facility details)

Updated on August 6, 2024

docx

URL: https://www.tga.gov.au/sites/default/files/manuf-forms-conformity-assessment-certificates-s3-3-140804.docx
Permalink: https://data.openrid.co/en/datasets/r/02ab00da-8c59-41a9-86f8-a69f8efdd410
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 6, 2024
Modified on: August 6, 2024

See the 13 main files

Medical device conformity assessment application

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

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