Notification form: Lapses in medical device conformity assessment certification - ARTG Entry - 2 - Therapeutic Goods Administration

ARTG Entry - 2

On this page there are questions related to the second affected ARTG entry. Enter one ARTG entry in the relevant field and provide further information related to this ARTG entry in subsequent fields.

You may add information for up to 20 models included under the affected ARTG entry on this page. If the ARTG entry has more than 20 models, you may use the next ARTG entry page(s) (ARTG entry – 3) to list details for the remaining models. If doing so, please ensure that the ARTG number and name is entered on all pages with model information related to the ARTG entry.

1. ARTG entry - 2

ARTG entry number - 2

ARTG entry name - 2

Current classification:

2. Are you intending to cancel the ARTG entry?

If you choose 'Yes' please provide an expected date of cancellation in the field below.

If you choose 'No' or 'Other' please specify in the text box below. You may also add further information related to this ARTG, if required.

Yes (please provide a date) No (please specify) Other (please specify)

By what date will you submit a device cancellation request to the TGA?

Day (dd)
-

Month (mm)
-

Year (yyyy)

Please specify:

3. Do you intend to supply devices included under this ARTG entry after the conformity assessment certification has lapsed?

Yes No

4. Were all the devices that you are intending to supply manufactured whilst the conformity assessment certification was current and valid?

Yes No

5. Supply Information

Please provide the name of each model and the requested data per unit of device supplied or expected to be supplied in Australia.

For example, if you supplied 10 units of Model-1 in Australia in the last 12 months (across all UPIs), then enter '10' in the relevant field below. Similarly, if you are expecting to supply 10 units of Model-1 in Australia during the lapsed timeframe (across all UPIs), then enter '10' in the relevant field below. Please note these are number-only fields.

Model- 1

Model- 1: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 1: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 2

Model- 2: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 2: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 3

Model- 3: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 3: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 4

Model- 4: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 4: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 5

Model- 5: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 5: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 6

Model- 6: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 6: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 7

Model- 7: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 7: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 8

Model- 8: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 8: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 9

Model- 9: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 9: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 10

Model- 10: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 10: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 11

Model- 11: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 11: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 12

Model- 12: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 12: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 13

Model- 13: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 13: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 14

Model- 14: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 14: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 15

Model- 15: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 15: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 16

Model- 16: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 16: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 17

Model- 17: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 17: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 18

Model- 18: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 18: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 19

Model- 19: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 19: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).

Model- 20

Model- 20: the number of devices supplied in Australia in the last 12 months for this model (across all UPIs).

Model- 20: the number of devices expected to be supplied in Australia during the lapsed timeframe for this model (across all UPIs).