COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
NOTICE OF PARTICULARS OF REVOCATION OF CONFORMITY ASSESSMENT CERTIFICATES UNDER SECTION 41EV OF THE THERAPEUTIC GOODS ACT 1989
I, Cheryl McRae, a delegate of the Secretary of the Department of Health for the purpose of section 41EV of the Therapeutic Goods Act 1989 (the Act), provide notice of the following particulars relating to the revocation of the following conformity assessment certificates under section 41ES of the Act:
(a) By written notice of revocation dated 25 August 2016, a delegate of the Secretary notified Teleflex Medical Australia Pty Ltd, the person in relation to whom Conformity Assessment Certificate AU Q00189 is taken to be issued pursuant to regulation 4.7 of the Therapeutic Goods (Medical Devices) Regulations 2002, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00189. The request for revocation follows the acquisition of Mayo Healthcare Pty Ltd (the company in relation to whom the Conformity Assessment Certificate AU Q00189 was issued) by Teleflex Australia in February 2014. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Teleflex Medical Australia dated 29 July 2016. The revocation took effect on 30 August 2016, being the day that the written notice of revocation was given to Teleflex Medical Australia Pty Ltd.
(b) By written notice of revocation dated 25 August 2016, a delegate of the Secretary notified National Diagnostics Products Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00344 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00344. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from National Diagnostics Products Pty Ltd dated 1 August 2016. The revocation took effect on 30 August 2016, being the day that the written notice of revocation was given to National Diagnostics Products Pty Ltd.
(c) By written notice of revocation dated 19 September 2016, a delegate of the Secretary notified ImpediMed Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00077 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00077. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from ImpediMed Ltd dated 12 September 2016. The revocation took effect on 19 September 2016, being the day that the written notice of revocation was given to ImpediMed Ltd.
(d) By written notice of revocation dated 11 January 2017, a delegate of the Secretary notified Micropace Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00070 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00070. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Micropace Pty Ltd dated 12 December 2016. The revocation took effect on 13 January 2017, being the day that the written notice of revocation was given to Micropace Pty Ltd.
(e) By written notice of revocation dated 6 February 2017, a delegate of the Secretary notified Johnson & Johnson Medical Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00069 (version 4) was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00069. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Johnson & Johnson Medical Pty Ltd dated 25 January 2017. The revocation took effect on 6 February 2017, being the day that the written notice of revocation was given to Johnson & Johnson Medical Pty Ltd.
(f) By written notice of revocation dated 24 February 2017, a delegate of the Secretary notified Edwards Lifesciences LLC, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00338 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00338. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Edwards Lifesciences LLC dated 20 February 2017. The revocation took effect on 24 February 2017, being the day that the written notice of revocation was given to Edwards Lifesciences LLC.
(g) By written notice of revocation dated 30 March 2017, a delegate of the Secretary notified Cyclomedica Australia Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00061 (version 3.1) was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00061. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Cyclomedica Australia Pty Ltd dated 16 March 2017. The revocation took effect on 4 April 2017, being the day that the written notice of revocation was given to Cyclomedica Australia Pty Ltd.
Signed by
Dr Cheryl McRae
Delegate of the Secretary
19 June 2017