Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 35796–37560

regulatory authority;
         (c) for the exchange of information between regulatory authorities when general information on individual manufacturers' capabilities is notified.
ISO 15225:2000(E) means International Standard ISO 15225:2000(E) (Nomenclature—Specification for a nomenclature system for medical devices for the purposes of regulatory data exchange).
relevant preferred term, for a medical device, means the preferred term for that device under ISO 15225:2000(E).
relevant template term, for a medical device, means the template term for that device under ISO 15225:2000(E).

1.8  Classes of persons that are not manufacturers of a medical device
  For the purposes of subsection 41BG(4) of the Act, a class of persons is health professionals, or suitably qualified persons within a healthcare facility, who produce a medical device (the final device) where the following are satisfied:
 (a) a medical device production system is used to produce the final device;
 (b) the medical device production system is included in the Register as a kind of medical device.

Part 2—Essential principles

2.1  Essential principles (Act s 41CA)
  For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1.

Part 3—Conformity assessment procedures

Division 3.1—Medical device classifications

3.1  Medical device classifications (Act s 41DB)
 (1) For section 41DB of the Act, the following table specifies the medical device classifications.

Medical device classifications
                                Column 1                                              Column 2  Column 3  Column 4  Column 5
Item                            Medical device                                        Class     Class     Class     Class