The following conditions apply to specific groups of therapeutic devices under the Therapeutic Goods Act 1989

Key:

Product Type

• Applicable Therapeutic Goods Orders
• Additional Conditions

Data:

1 - All therapeutic devices

• TGO 37 - "General requirements for Labels for Therapeutic Devices"
• As specified in standard conditions

2 - All therapeutic devices supplied sterile

• TGO 11 - "Standard for Sterile Therapeutic Goods"
• As specified in standard conditions

3.1 - In-Vitro Diagnostic Goods (IVDGs) for home use or supplied as a Commonwealth Pharmaceutical Benefit under the National Health Act 1953 or the Veterans' Entitlement Act 1986

• TGO 34 - "Standard for Diagnostic Goods of Human Origin", if applicable
• Must be accompanied by adequate instructions and information in plain English which outlines clearly the nature, use and limitations of the test and expresses measurements in Standard International units

3.2 - IVDGs containing material of human origin

• TGO 34 - "Standard for Diagnostic Goods of Human Origin"
• *Test certificate on request. Current catalogues and detailed records of importation and distribution of the goods must be kept

3.3 - IVDGs used for the diagnosis of infection with testing Human Immunodeficiency Virus (HIV)

• TGO 34 - "Standard for Diagnostic Goods of Human Origin", if applicable
• May be supplied to laboratories on the Department of Administrative Services' list of "Supplemental and Screening HIV Period Contracts" only

3.4 - IVDGs approved as a supplemental test for the diagnosis of infection with Hepatitis C Virus (HCV)

• TGO 34 - "Standard for Diagnostic Goods of Human Origin", if applicable
• May be supplied to authorised laboratories only

4 - Condoms

• TGO 39 - "Contraceptive Devices - Rubber Condoms"
• *Test certificate must be obtained for every batch prior to supply

5 - Contraceptive diaphragms

• TGO 28 - "Standard for Contraceptive Devices - Diaphragms"
• *Test certificate must be obtained for every batch prior to supply

6 - Insulin syringes

• TGO 41 - "Single-use syringes (sterile) for the injection of 100 units per millilitre of insulin (U-100)"
• *Test certificate on request

7 - Sutures or ligatures

• TGO 49 - "General Standard for Sutures"
• *Test certificate on request

8.1 - Primary dressings, surgical absorbents or goods specified in Schedule 11 of the Regulations

• TGO 11 - "Standard for Sterile Therapeutic Goods"
• Must be sterile and labelled "sterile"

8.2 - Bandages, dressings and allied products supplied non-sterile

• --
• Total microbial count, as determined by the TGA approved method, must be less than 10,000 organisms/g. *Test certificate on request

9 - Urethral catheters

• TGO 38 - "Single-use Urethral Catheters (Sterile) for General Medical Use"
• *Test certificate on request

10 - Dental restoratives

• TGO 43 - "Dental Materials"
• *Test certificate on request

11 - Menstrual tampons

• TGO 51 - "Standard for Tampons, Menstrual"
• *Test certificate on request

12 - Barium hydroxide lime

• TGO 47 - "Barium Lime"
• *Test certificate on request

13 - Examination gloves

• TGO 42 - "Examination Gloves for general medical and dental use"
• *Test certificate on request

14 - Inflatable penile implants (except breast implants) or devices containing silicone gel

• --
• **Annual problem reports

15 - Products presented as being pyrogen-free and all devices specified in the Order

• TGO 50 - "General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods"
• *Test certificate on request

*Test certificate on request - the sponsor of the goods must obtain a test certificate, consisting of a detailed certificate of compliance containing comments against each requirement of the Order, for any batch of goods supplied in Australia and this must be available whenever the Secretary or a delegate of the Secretary appointed for the purposes of Section 28 of the Act, should request it to be produced for inspection.

**Annual problem reports - a report of problems relating to the condition, use or application of the devices must be submitted to the Director, Therapeutic Devices Branch between 1 July and 1 October each year.