Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 (Cth)

Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

I, Miranda Lauman, as delegate of the Minister for Health, make the following order.

Dated 26 March 2019

Miranda Lauman Assistant Secretary Medical Devices Branch Health Products Regulation Group Department of Health

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Conformity assessment standardsquality management systems 6 Conformity assessment standardsquality management systems for kinds of medical devices intended to be supplied in a sterile state 7 Repeals Schedule 1—Conformity assessment standards Schedule 2—Conformity assessment standards for medical devices intended to be supplied in a sterile state Schedule 3—Repeals Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008

1 Name This instrument is the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019.

2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 31 March 2019. 31 March 2019

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.