F2025L00414Therapeutic Goods Legislation Checker

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Specimen of the kit

SPECIMEN. Three sample rows only. This is not the paid kit. The paid kit carries all 21 units, the full evidence list and the dated plan.

Register shape

RefCitationTitleRequirement (our words)EvidenceStatus
SPECIMEN-01Sch 1 item 1, reg 9A.1(1) to (3)Establish and maintain the UDI databaseThe Secretary must make sure a database for Australian device identification exists. The Secretary must keep the whole database, or agree in writing with another person to keep all of it, or keep part and agree in writing for the rest to be kept on the Commonwealth's behalf....A current data-flow map that names the database operator and the receiving agencyOpen
SPECIMEN-02Sch 1 item 1, reg 9A.1(4) to (5)Personal information and written consentThe database may hold personal information only in three cases: the name of a person connected to a kind of device on the Register, an authorised representative of the manufacturer, or an authorised representative of a person connected to a registered device. Information about a representative in the second or third case may be entered only after that representative consents in writing....A field-level data map that gives every field a category and the clause it relies onOpen
SPECIMEN-03Sch 1 item 1, reg 9A.1(6) to (7)Keep device records after suspension or cancellationWhen Part 4-6 of the Act suspends a model, its database information must stay for the length of the suspension, unless the Secretary concludes that removal is appropriate. When a model is cancelled, the information must stay unless the Secretary is satisfied that removal is appropriate....A retention note that treats device data and representative information as different categoriesOpen

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Specimen rows are labelled. They are not a substitute for the kit and they do not certify anything. Not legal advice.