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 eight conformity assessment certificates under section 41ES of the Act:
(a) By written notice of revocation dated 17 September 2015, a delegate of the Secretary notified Novapharm Research Australia Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00174. The revocation was made under section 41ES of the Act in acordance with a written request for revocation from Novapharm Research Australia Pty Ltd dated 3 September 2015. The revocation took effect on 17 September 2015, being the day that the written notice of revocation was given to Novapharm Research Australia Pty Ltd.
(b) By written notice of revocation dated 10 March 2016, a delegate of the Secretary notified Australian Orthopaedic Fixations Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00221. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Australian Orthopaedic Fixations Pty Ltd dated 26 November 2015. The revocation took effect on 11 March 2016, being the day that the written notice of revocation was given to Australian Orthopaedic Fixations Pty Ltd.
(c) By written notice of revocation dated 15 March 2016, a delegate of the Secretary notified Smith & Nephew Inc of its decision to revoke the Conformity Assessment Certificate AU D00293. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Smith & Nephew Inc dated 9 December 2015. The revocation took effect on 15 March 2016, being the day that the written notice of revocation was given to Smith & Nephew Inc.
(d) By written notice of revocation dated 10 March 2016, a delegate of the Secretary notified Imaxeon Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00050. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Imaxeon Pty Ltd dated 13 January 2016. The revocation took effect on 10 March 2016, being the day that the written notice of revocation was given to Imaxeon Pty Ltd.
(e) By written notice of revocation dated 15 March 2016, a delegate of the Secretary notified SDI Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00053. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from SDI Ltd dated 2 February 2016. The revocation took effect on 15 March 2016, being the day that the written notice of revocation was given to SDI Ltd.
(f) By written notice of revocation dated 15 March 2016, a delegate of the Secretary notified Nanosonics Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00207. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Nanosonics Ltd dated 9 March 2016. The revocation took effect on 15 March 2016, being the day that the written notice of revocation was given to Nanosonics Ltd.
(g) By written notice of revocation dated 27 May 2016, a delegate of the Secretary notified Biodental Technologies Pty Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00113. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Biodental Technologies Pty Ltd dated 19 May 2016. The revocation took effect on 31 May 2016, being the day that the written notice of revocation was given to Biodental Technologies Pty Ltd.
(h) By written notice of revocation dated 9 June 2016, a delegate of the Secretary notified Alere Medical Company Ltd of its decision to revoke the Conformity Assessment Certificate AU Q00348. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Alere Medical Company Ltd dated 6 June 2016. The revocation took effect on 10 June 2016, being the day that the written notice of revocation was given to Alere Medical Company Ltd.
(Signed by)
Dr Cheryl McRae
Delegate of the Secretary
21 July 2016