Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_13a
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 13A
Character Range: 302956–304678

13A  Patient information about implantable medical devices or active implantable medical devices to be made available

13A.1  Scope of clauses 13A.2 to 13A.4
 (1) Clauses 13A.2 to 13A.4 apply to a medical device that is:
 (a) an implantable medical device or an active implantable medical device; and
 (b) not a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar article; and
 (ba) not intended by the manufacturer to be for export only; and
 (c) not a medical device to which subclause (2) applies.
 (2) This subclause applies to a medical device if:
 (a) the medical device is intended by the manufacturer to be wholly, or mostly, absorbed by a patient's body within 6 months of being implanted; and
 (b) the medical device is:
 (i) for use as a filler; or
 (ii) for haemostasis; or
 (iii) for tissue approximation; or
 (iv) for the fixation of other medical devices within tissue; or
 (v) a similar medical device to a medical device covered by subparagraph (i), (ii), (iii) or (iv).

13A.2  Patient implant cards etc. for implantable devices
 (1) Either:
 (a) a card (a patient implant card) that includes the information covered by subclause (2) and that satisfies clause 13A.4 must be made available for provision to the patient concerned; or
 (b) information covered by subclause (2) that is in electronic form and that satisfies clause 13A.4 must be made available in a way that is readily accessible by the patient concerned.
 (2) The information covered by this subclause is the information in the following table.

Information to be made available for provision to patient
Item                                                       Information