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THERAPEUTIC GOODS ACT 1989 - SECT 41JA

Secretary may require information or documents

             (1)  The Secretary may, by written notice given to a person:

                     (a)  who is an applicant for a conformity assessment certificate that would relate to a kind of medical device; or

                     (b)  who holds a conformity assessment certificate that relates to a kind of medical device; or

                   (ba)  who held, at any time during the notice period under subsection (2), a conformity assessment certificate that related to a kind of medical device; or

                     (c)  who is an applicant for the inclusion of a kind of medical device in the Register; or

                     (d)  in relation to whom a kind of medical device is included in the Register; or

                   (da)  in relation to whom a kind of medical device was, at any time during the notice period under subsection (2), included in the Register;

require the person to give to the Secretary information or documents, relating to devices of that kind, that are relevant to one or more of the following:

                     (e)  whether the devices comply with the essential principles;

                      (f)  whether the conformity assessment procedures have been applied to the devices;

                     (g)  whether the devices comply with conditions (if any) imposed on a conformity assessment certificate issued in respect of the device or the inclusion of the device in the Register;

                     (h)  whether either of the following has not been complied with in relation to the devices:

                              (i)  an applicable provision of the Therapeutic Goods Advertising Code;

                             (ii)  any other requirement relating to advertising applicable under Part 5-1 or under the regulations;

                      (i)  if the kind of medical device is included in the Register in relation to the person--whether medical devices of that kind are being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia;

                    (ia)  the safety and efficacy of the devices for the purposes for which they are to be used;

                    (ib)  the regulatory history of the devices in another country;

                      (j)  any other matter prescribed by the regulations for the purposes of this paragraph.

       (1AA)  If a notice is given under subsection (1) to a person covered by paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the person held the certificate.

       (1AB)  If a notice is given under subsection (1) to a person covered by paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the kind of medical device was included in the Register.

          (1A)  The Secretary may, by written notice given to a person who is an applicant for a conformity assessment certificate, require the person to give to the Secretary such further information concerning the application as is specified in the notice.

          (1B)  Requirements under subsections (1) and (1A) may be included in the same notice.

          (1C)  The Secretary may, by written notice given to a person who holds a conformity assessment certificate, require the person to give to the Secretary specified information to be used by the Secretary in deciding whether to suspend the certificate under section 41EM, or to revoke the certificate under section 41ET, in relation to the circumstances referred to in paragraph 41ET(1)(e).

          (1D)  Requirements under subsections (1) and (1C) may be included in the same notice.

             (2)  For the purposes of paragraphs (1)(ba) and (da), the notice period is the period:

                     (a)  of the length specified in the regulations; and

                     (b)  ending on the day before the Secretary gives the notice under subsection (1).

             (3)  Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).



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