Document ID: chunk:federal_register_of_legislation:F2017L00965:body:0:p2
Version: federal_register_of_legislation:F2017L00965
Segment Type: other
Provision Reference: 
Character Range: 3452–7658

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 the TGA about the performance or competence of NATA-accredited laboratories engaged in the manufacture of in-house IVDs [clauses 6.9 and 7.6]                                                                                                                                                                               For example, sharing of information relating to an adverse event for an in-house IVD that raises concerns with respect to the performance of the in-house IVD.

(d)   The following information relating to a laboratory engaged in the manufacture of in-house IVDs:                                                                                                                                                                                                                                                                 For example, sharing of information in relation to a notification provided to the TGA by a laboratory of their Class 1-3 in-house IVDs being manufactured, in order to assist NATA prepare for an accreditation assessment activity for that laboratory.
          * a list of all Class 1-3 in-house IVDs manufactured by the laboratory, and the date the laboratory last notified the TGA of the details of the Class 1-3 in-house IVDs that it was manufacturing at that time;
          * a list of all Class 4 in-house IVDs manufactured by the laboratory;                                                                                                                                                                                                                                                                                       For example, sharing of information relating to the number of Class 4 in-house IVDs manufactured by a NATA-accredited laboratory that are included in the ARTG (or are otherwise exempt from inclusion).
          * details of any assessments being undertaken in relation to any technical or scientific data that supports the performance of a Class 4 in-house IVD that was   provided by the applicant with their application for inclusion in the ARTG; and
          * details of any post-market investigations undertaken by the TGA relating to aspects of concern, including any technical or scientific data provided by a laboratory, in relation to any in-house IVDs manufactured by the laboratory; [clause 7.2]                                                                                                        For example, sharing of information in relation to the assessment of any technical or scientific data provided by a NATA-accredited laboratory to support their application for inclusion of a Class 4 in-house IVD in the ARTG (where the laboratory is utilising their NATA accreditation to support an application for inclusion).
          * information of a kind which the laboratory is required to notify the Secretary of as part of their post market system requirements in accordance with paragraph 6A.4(2)(c) of Schedule 3 to the MD Regulations (for Class 1, 2 or 3 in-house IVDs) or paragraph 6B.5(2)(c) of Schedule 3 to the MD Regulations (for Class 4 in-house IVDs); [clause 7.3]
                                                                                                                                                                                                                                                                                                                                                                      For example, sharing of information, including technical or scientific data, relating to a reported adverse event for a Class 4 in-house IVD that raises safety concerns with respect to the performance or competence of a NATA-accredited laboratory engaged in the