You may need to comply with these orders if you are involved in the manufacturing or production of therapeutic goods, including biologicals and medical devices.
Therapeutic goods are broadly defined as products for use in humans in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
- influencing, inhibiting or modifying a physiological process
- testing the susceptibility of persons to a disease or ailment
- influencing, controlling or preventing contraception
- testing for pregnancy.
This includes things that are:
- used as an ingredient or component in the manufacture of therapeutic goods
- used to replace or modify parts of the anatomy.
