The TGA is a division of the Australian Government Department of Health and Ageing, and is the conformity assessment procedures selected
ivd-ca-overview.pdf
Subsection 41EJ (3) of the Act, and the conformity assessment procedures in Schedule 3, Part 1 of Therapeutic Goods (Medical Devices) Regulations 2002 (the
Changes-affecting-TGA-issued-conformity-assessment-certificates.pdf
25 nov 2019 · AU Q00345 TGA Conformity Assessment Certificate Page 1 of 4 Conformity Assessment Certificate Full Quality Assurance Procedures
tga-certificate-au-q00345---issued-25112019.pdf
25 août 2017 · AU Q00154 TGA Conformity Assessment Certificate Page 1 of 4 Conformity Assessment Certificate Production Quality Assurance Procedures
D17-713911-TGA-certificate-AU-Q00154-Version2.2-Issued-2017-08-25.pdf
assessment procedures5 will be unchanged The high risk devices specified under Regulation 4 16 would continue to require TGA conformity assessment
11-22-16-TGAproposal.pdf
CONFORMITY ASSESSMENT PROCEDURES FOR MEDICAL DEVICE APPROVED BY RECOGNISED COUNTRIES PURPOSE Therapeutic Goods Administration (TGA) licence
malaysia-circular-2-eng.pdf
Name: Australian Therapeutic Goods Administration (TGA) The Australian conformity assessment procedure is based on the GHTF yet differs from the EU
aus.pdf
TGA's overall conformity assessment evaluation process This will result in the TGA being able to reduce the amount of assessment that it must undertake on
use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds.pdf