Notification form: Lapses in medical device conformity assessment certification - Information Related to the Medical Device(s) - Therapeutic Goods Administration

Information Related to the Medical Device(s)

On this page there are questions related to the medical device(s) with lapsing or lapsed conformity assessment certification.

1. Medical device(s) sponsor details:

Sponsor's name (Required)

Sponsor's email address

Sponsor's phone number

2. Medical device(s) manufacturer details:

Manufacturer's name (Required)

3. When is the medical device conformity assessment certification lapsing or when did it lapse?

Expiry Date (Required)

Day (dd)
-

Month (mm)
-

Year (yyyy)

4. Is the manufacturer seeking new conformity assessment certification?

(Required) Yes, please provide an estimated date below No, please skip to question number 5

If yes, by what date is the manufacturer expecting to receive the new (valid) conformity assessment certification? (This can be a rough estimate, if you are unsure about the date, please enter first of the expected month and year).

Day (dd)
-

Month (mm)
-

Year (yyyy)

5. Please specify the reason why the conformity assessment certification is lapsing or has lapsed.

(Required) EU MDR transition Suspension of the certification Revocation of the certification Lapses due to issues related to COVID-19 pandemic Expiry due to other reasons (please specify)

Please specify: