Finder EU notified body intelligence
0805

THERAPEUTIC GOODS ADMINISTRATION

Australia · ACT Active

www.tga.gov.au

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex II, Annex IV, Annex III, Annex VI, Annex V
Designated since2006-04-09
Full scope text from the register
Annexes
  • Annex II, Annex IV, Annex III, Annex VI, Annex V
Procedures
  • EC type-examination, EC verification, Product quality assurance, Full quality assurance system, Production quality assurance
Products
  • All medical devices
MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex II, Annex IV, Annex III, Annex VI, Annex V
Designated since2006-04-09
Full scope text from the register
Annexes
  • Annex II, Annex IV, Annex III, Annex VI, Annex V
Procedures
  • EC type-examination, EC verification, Product quality assurance, Full quality assurance system, Production quality assurance
Products
  • All medical devices
Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=0805

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.