Commonwealth Numbered Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Download] [Help]

THERAPEUTIC GOODS AMENDMENT REGULATIONS 2004 (NO. 1) 2004 NO. 78 - SCHEDULE 2

Amendments of Therapeutic Goods (Medical Devices)Regulations 2002

(regulation 4)

[1] Schedule 4, item 2.2, paragraph (b)

omit

goods

insert

device

[2] Schedule 4, after item 2.5

insert

2.6


Medical device that is imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner)


(a) The medical practitioner or medical team must be accompanying a person to Australia who:
(i) has a critical illness; and
(ii) is under the direct care and supervision of the practitioner or team.




(b) The device must be for use in the treatment of the person who has the critical illness.
(c) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956 .
(d) The quantity of the device imported must be consistent with the quantity required for the treatment of the person mentioned in paragraph (b).




(e) The device must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph (b).
(f) The device must be destroyed or removed from Australia at the end of the visit.




(g) The medical practitioner, or a member of the medical team, must be responsible for the control and custody of the device while the practitioner or team is in Australia.




(h) The person mentioned in paragraph (g) must:
(i) carry a list, in English, of the quantity and nature of the device imported; and
(ii) keep a record of the use of the device while the medical practitioner or medical team is in Australia; and
(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.


2.7


Medical device that is imported into Australia by a member of a group of persons, being a group that includes a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business


(a) The device must be for use in the treatment of a member or members of the visiting group.
(b) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956 .
(c) The device must not be supplied to, or used in the treatment of, a person other than a member of the visiting group.
(d) The device must be destroyed or removed from Australia at the end of the visit.




(e) A member of the visiting group must be responsible for the control and custody of the device while the group is in Australia.
(f) The person mentioned in paragraph (e) must:
(i) carry a list, in English, of the quantity and nature of the device imported; and
(ii) keep a record of the use of the device while the group is in Australia; and
(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.


2.8


Medical device that is part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia


(a) The device must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft.
(b) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956 .




(c) The quantity of the device imported must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft.
(d) The device must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft.
(e) The device must not be removed from the ship or aircraft while the ship or aircraft is in Australia.




(f) The master of the ship or the pilot of the aircraft must be responsible for the control and custody of the device while the ship or aircraft is in Australia.
(g) The person mentioned in paragraph (f) must:
(i) carry a list, in English, of the quantity and nature of the device imported; and
(ii) keep a record of the use of the device while the ship or aircraft is in Australia; and
(iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.




AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback