THERAPEUTIC GOODS ACT 1989 - SECT 41CE Database of unique device identifiers of medical devices
THERAPEUTIC GOODS ACT 1989 - SECT 41CE
Database of unique device identifiers of medical devices(1) The regulations may make provision for and in relation to the Secretary causing a database to be established and maintained, to be known as:
(a) the Australian Unique Device Identification Database; or
(b) if another name is prescribed by the regulations--that other name.
Note: The essential principles may include requirements in relation to the inclusion in the database of unique device identifiers of medical devices and related information: see subsection 41CA(3).
(2) The regulations must provide that the database must not include personal information, unless the personal information:
(a) is the name of a person in relation to whom a kind of medical device is included in the Register; or
(b) is about an authorised representative of the manufacturer of a kind of medical device; or
(c) is about an authorised representative of a person in relation to whom a kind of medical device is included in the Register.
(3) The regulations may provide for the removal of information from the database.
(4) The regulations may provide for corrections to information in the database.
(5) The regulations may provide for the whole or a part of the database to be made:
(a) available to specified persons, authorities or bodies; or
(6) However, the regulations must provide that personal information covered by paragraph (2)(b) or (c) must not be made publicly available.
No limit on subsection (1)
(7) Subsections (2) to (6) do not limit subsection (1).
Database not a legislative instrument
(8) The database is not a legislative instrument.