Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019
- Number
- F2019L00426
- Type
- Regulation
- Issuer
- Australian Government / TGA (Department of Health)
- Status
- in_force
- Authority
- TGA
What this covers
治疗用品（质量管理体系符合性评定标准）令 2019。规定医疗器械制造商质量管理体系须满足的符合性评定标准，实务上对应 ISO 13485 体系要求。
Official text: https://www.legislation.gov.au/F2019L00426/latest/text
Facts only; not legal advice. The official current text prevails.