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THERAPEUTIC GOODS LEGISLATION AMENDMENT (2017 MEASURES NO. 2) REGULATIONS 2017 (F2017L01561) - SCHEDULE 1

Approval of medical devices

   

Therapeutic Goods (Medical Devices) Regulations 2002

1  After Division 4.1

Insert:

Division 4.1A -- Conformity assessment (priority applicant) determinations

4.3A   Application of Division

                   For the purposes of subsection 41ECA(1) of the Act, this Subdivision makes provision for and in relation to the making of conformity assessment (priority applicant) determinations.

4.3B   Application for conformity assessment (priority applicant) determination

             (1)  A person may apply to the Secretary for a conformity assessment (priority applicant) determination in relation to a medical device.

             (2)  An application under subregulation (1) must:

                     (a)  be in writing; and

                     (b)  be in a form approved, in writing, by the Secretary; and

                     (c)  have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.

             (3)  An application under subregulation (1) is taken not to have been made unless:

                     (a)  the application meets the requirements in subregulation (2); and

                     (b)  the fee prescribed in item 1.1A of Part 1 of Schedule 5 for making the application has been paid.

4.3C   Making of conformity assessment (priority applicant) determination

             (1)  On receiving an application under subregulation 4.3B(1) for a conformity assessment (priority applicant) determination in relation to a medical device, the Secretary must:

                     (a)  consider the application; and

                     (b)  decide either:

                              (i)  to make the determination; or

                             (ii)  to refuse to make the determination.

Criteria

             (2)  The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device ):

                     (a)  the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition;

                     (b)   either:

                              (i)  no medical devices with that intended purpose are of a kind included in the Register; or

                             (ii)  if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices )--there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;

                     (c)  at least one of the following applies to the new device:

                              (i)  the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;

                             (ii)  there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;

                            (iii)  the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit .

Information to be specified in determination

             (3)  The determination must specify:

                     (a)  the person who, as a result of section 41ECA of the Act, is the priority applicant; and

                     (b)  the medical device to which the determination relates; and

                     (c)  the intended purpose of the medical device.

Notification of decision

             (4)  As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.

             (5)  If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.

4.3D   Period during which conformity assessment (priority applicant) determination is in force

             (1)  A conformity assessment (priority applicant) determination in relation to a medical device:

                     (a)  comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 4.3C(4); and

                     (b)  subject to subregulation (2) and regulation 4.3E, remains in force for 6 months.

             (2)  If the 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.

2  Before regulation 5.2

Insert:

Subdivision A -- Applications

3  After regulation 5.2

Insert:

Subdivision C -- Auditing of applications

4  At the end of Division 5.1

Add:

Subdivision D -- Miscellaneous--medical devices (priority applicant) determinations

5.4   Application of Subdivision

                   For the purposes of subsection 41FKA(1) of the Act, this Subdivision makes provision for and in relation to the making of medical devices (priority applicant) determinations.

5.4A   Application for medical devices (priority applicant) determination

             (1)  A person may apply to the Secretary for a medical devices (priority applicant) determination in relation to a medical device.

             (2)  An application under subregulation (1) must:

                     (a)  be in writing; and

                     (b)  be in a form approved, in writing, by the Secretary; and

                     (c)  have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.

             (3)  An application under subregulation (1) is taken not to have been made unless:

                     (a)  the application meets the requirements in subregulation (2); and

                     (b)  the fee prescribed in item 1.5A of Part 1 of Schedule 5 for making the application has been paid.

5.4B   Making of medical devices (priority applicant) determination

             (1)  On receiving an application under subregulation 5.4A(1) for a medical devices (priority applicant) determination in relation to a medical device, the Secretary must:

                     (a)  consider the application; and

                     (b)  decide either:

                              (i)  to make the determination; or

                             (ii)  to refuse to make the determination.

Criteria

             (2)  The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device ):

                     (a)  the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition;

                     (b)   either:

                              (i)  no medical devices with that intended purpose are of a kind included in the Register; or

                             (ii)  if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices )--there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;

                     (c)  at least one of the following applies to the new device:

                              (i)  the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;

                             (ii)  there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;

                            (iii)  the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit .

Information to be specified in determination

             (3)  The determination must specify:

                     (a)  the person who, as a result of section 41FKA of the Act, is the priority applicant; and

                     (b)  the medical device to which the determination relates; and

                     (c)  the intended purpose of the medical device.

Notification of decision

             (4)  As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.

             (5)  If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.

5.4C   Period during which medical devices (priority applicant) determination is in force

             (1)  A medical devices (priority applicant) determination in relation to a medical device:

                     (a)  comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 5.4B(4); and

                     (b)  subject to subregulation (2) and regulation 5.4D, remains in force for 6 months.

             (2)  If the priority applicant specified in the determination makes an effective application under section 41FC of the Act for that kind of medical device to be included in the Register 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 41FK of the Act; or

                     (c)  the application is finally determined.

Note:          See subsection 41FC(2) of the Act for when an application under section 41FC of the Act is effective.

5.4D   Revocation of medical devices (priority applicant) determination

             (1)  The Secretary may revoke a medical devices (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 41FC of the Act for that kind of medical device to be included in the Register; 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 5.4B(2) are no longer satisfied in relation to the medical device.

Note:          See subsection 41FC(2) of the Act for when an application under section 41FC of the Act is effective.

             (2)  The revocation must be by written notice given by the Secretary to the priority applicant.

5  Subregulation 10.7(1) (paragraph (a) of the definition of initial decision )

Repeal the paragraph, substitute:

                     (a)  subparagraph 4.3C(1)(b)(ii);

                    (aa)  subregulation 4.3E(1);

                   (ab)  subregulation 4.10(2);

                    (ac)  subparagraph 5.4B(1)(b)(ii);

                   (ad)  subregulation 5.4D(1);

6  After subregulation 10.7(3)

Insert:

          (3A)  Despite subregulation (3), only the following persons may make a request under that subregulation in relation to a conformity assessment (priority applicant) determination:

                     (a)  if the initial decision was to refuse to make the determination--the person who applied for the determination;

                     (b)  if the initial decision was to revoke the determination--the priority applicant specified in the determination.

          (3B)  Despite subregulation (3), only the following persons may make a request under that subregulation in relation to a medical devices (priority applicant) determination:

                     (a)  if the initial decision was to refuse to make the determination--the person who applied for the determination;

                     (b)  if the initial decision was to revoke the determination--the priority applicant specified in the determination.

7  Part 1 of Schedule 5 (after table item 1.1)

Insert:

 

1.1A

Application for conformity assessment (priority applicant) determination in relation to a medical device

Paragraph 41ECA(3)(d) of the Act

9,660

8  Part 1 of Schedule 5 (after table item 1.5)

Insert:

 

1.5A

Application for medical devices (priority applicant) determination in relation to a medical device

Paragraph 41FKA(3)(d) of the Act

9,660

9  Dictionary

Insert:

"conformity assessment (priority applicant) determination" has the meaning given by subsection 41ECA(2) of the Act.

10  Dictionary (definition of intended purpose )

Omit "kind of".

11  Dictionary

Insert:

"medical devices (priority applicant) determination " has the meaning given by subsection 41FKA(2) of the Act.



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