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Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017
Therapeutic Goods Act 1989

I, ADRIANA PLATONA, a delegate of the Minister for Health, make this Specification under subsection 61(5AB) of the Therapeutic Goods Act 1989.

Dated 25 July 2017

(Signed by)

ADRIANA PLATONA
Delegate of the Minister for Health

1 Name of Specification
  This Specification is the Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017.
2 Commencement
  This Specification commences on the day after it is registered.
3 Definitions
  In this Specification:
      Act means the Therapeutic Goods Act 1989.
      ARTG means the Australian Register of Therapeutic Goods.
      IVD medical device has the same meaning as in the MD Regulations.
      in-house IVD medical device (in-house IVD) has the same meaning as in the MD Regulations.
      MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
      NATA means the National Association of Testing Authorities, of Australia.
      TGA means the Therapeutic Goods Administration, which is part of the Department of Health.
4 Therapeutic goods information, persons and purposes
  The kinds of therapeutic goods information, persons, bodies and purposes, mentioned in Schedule 1 are specified under subsection 61(5AB) of the Act, for the purposes of subsection 61(5AA) of the Act.
Schedule 1 Specified kinds of therapeutic goods information, persons, bodies and purposes
(section 4)

The following kinds of therapeutic goods information, persons, bodies and purposes:

    Note 1: The following specified kinds of therapeutic goods information may be released by the Secretary under subsection 61(5AA) of the Act to the following specified bodies and kinds of persons, for the following specified purposes.
    Note 2: References in the Table below to clauses are references to clauses in the Memorandum of Understanding between the Commonwealth of Australia and NATA, in relation to In-House In Vitro Diagnostic Medical Devices, made on 2 September 2016.

    1.  Therapeutic goods information:

    The following kinds of therapeutic goods information, being information that relates to in-house IVDs and that is held by the TGA:

Item  Information                                                                                                                                                                                                                                                                                                                                                     Description
(a)   Information relating to the assessment of laboratories engaged in the manufacture of in-house IVDs [clause 5.1(c)]                                                                                                                                                                                                                                              For example, sharing of information related to the assessment of a laboratory engaged in the manufacture of a Class 4 in-house IVD in relation to an application for inclusion in the ARTG, where the laboratory is utilising their existing NATA accreditation to support an application for inclusion.
(b)   Information relating to trends in technology and laboratory practice regarding in-house IVDs, including in relation to the clinical utility, misuse or performance of in-house IVDs [clause 5.5]                                                                                                                                                                For example, sharing of information for the development of guidance for industry in relation to emerging technologies.
(c)   Information relating to concerns of