9A.1Australian Unique Device Identification Database

#### 9A.1 Australian Unique Device Identification Database (1) For the purposes of section 41CE of the Act, the following provisions of this regulation have effect. Establishing the database (2) The Secretary must cause a database to be established (the Australian Unique Device Identification Database). Maintaining the database (3) The Secretary must: (a) maintain the whole of the database; or (b) on behalf of the Commonwealth, enter into a written agreement with a person to maintain the whole of the database; or (c) maintain some of the content of the database and, on behalf of the Commonwealth, enter into a written agreement with a person to maintain the remaining content of the database. Personal information (4) 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. (5) Personal information covered by paragraph (4)(b) or (c) must not be included in the database unless the authorised representative concerned consents, in writing, to that inclusion. Retention of information during suspension or cancellation of Register entry (6) If information is included in the database in relation to UDI medical devices that are a type of model and that model is covered by a suspension under Part 4‑6 of the Act, that information must not be removed from the database during the period of the suspension unless the Secretary is satisfied that it is appropriate in all the circumstances to do so. (7) If information is included in the database in relation to UDI medical devices that are a type of model and that model is covered by a cancellation under Part 4‑6 of the Act, that information must not be removed from the database unless the Secretary is satisfied that it is appropriate in all the circumstances to do so. Removal of information (8) The Secretary may remove information from the database in relation to UDI medical devices that are a type of model if: (a) the information is not information required by this instrument to be included in the database; and (b) a sponsor or manufacturer of those medical devices requests the Secretary, in writing, to remove the information. (9) The Secretary may remove information from the database in relation to UDI medical devices that are a type of model if the Secretary is satisfied that the information is incomplete or incorrect. (10) The Secretary must remove information from the database that is personal information, other than personal information covered by paragraph (4)(a), (b) or (c). (11) However, the Secretary must remove personal information covered by paragraph (4)(b) or (c) from the database if the authorised representative concerned requests the Secretary, in writing, to do so. Corrections to information (12) The Secretary may correct information in the database in relation to UDI medical devices that are a type of model if the Secretary is satisfied that: (a) it is not possible or practicable for a sponsor or manufacturer, or another person on behalf of a sponsor or manufacturer, of those medical devices to make the correction; or (b) it is in the interests of public health or safety to do so. Making database publicly available (13) The Secretary may arrange for the whole or a part of the database to be made publicly available. However, personal information covered by paragraph 41CE(2)(b) or (c) of the Act must not be made publicly available.