Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p11
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 11/40)
Character Range: 63298–66212

priority applicant specified in the determination makes an effective application under section 41EB of the Act for a conformity assessment certificate that covers the medical device before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
 (a) the priority applicant withdraws the application; or
 (b) the application lapses in accordance with section 41EG of the Act; or
 (c) the application is finally determined.
Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective.

4.3E  Revocation of conformity assessment (priority applicant) determination
 (1) The Secretary may revoke a conformity assessment (priority applicant) determination in relation to a medical device if:
 (a) either:
 (i) the priority applicant specified in the determination has not made an application under section 41EB of the Act for a conformity assessment certificate that covers the medical device; or
 (ii) the priority applicant has made such an application, but the application is not effective; and
 (b) the Secretary is satisfied that the criteria specified in subregulation 4.3C(2) are no longer satisfied in relation to the medical device.
Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective.
 (2) The revocation must be by written notice given by the Secretary to the priority applicant.

Division 4.1B—Content of conformity assessment certificates

4.3F  Content of conformity assessment certificates
  For the purposes of subsection 41EE(3) of the Act, the information is all of the following:
 (a) a unique identification number for the certificate;
 (b) the day on which the certificate is issued;
 (c) the name and address of the manufacturer of the medical devices;
 (d) the conformity assessment procedures applied to the medical devices by the manufacturer;
 (e) if the certificate covers a medical device to which paragraph 1.6(a), (b), (c) or (d) applies—the unique product identifier of the device;
 (f) the conditions to which the certificate is subject under section 41EJ or 41EK of the Act;
 (g) if one or more conformity assessment certificates have previously been issued in respect of the medical devices—the day on which each of those certificates was issued;
 (h) the signature and name of the person issuing the certificate.

Division 4.1C—Conditions

4.3G  Conditions applying automatically—information about poisons
 (1) This regulation applies to a conformity assessment certificate that covers a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.
 (2) However, this regulation does not apply to the certificate if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device.
 (3) For the purposes