Orthosis

Main information

  • Trade name:
  • Orthosis, footwear, orthopaedic, shoe,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthosis, footwear, orthopaedic, shoe,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219767
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219767

Foot Levelers of Australia LLC - Orthosis, footwear, orthopaedic, shoe, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Foot Levelers of Australia LLC

Postal Address

Unit 1 / 50 George Street,Clyde, NSW, 2142

Australia

ARTG Start Date

31/01/2014

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41FN of the Therapeutic

Goods Act 1989.

The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the

Register are as set out in the following paragraphs.

For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor

is provided in such a way as to allow the sponsor to be identified.

Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of

records relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device, the

distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall

be retained for a minimum period of 5 years.

The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation

5.8.

It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class IIb provides three

consecutive annual reports to the Head of the Office of Product Review, Therapeutic Goods Administration following inclusion of the device in the ARTG

(as specified in 5.8 of the regulations). Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first

report following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be

provided on 1 October for a further 2 years. The annual report must include all complaints and adverse events received by the manufacturer relating to

problems with the use of the device that have been received by them over the year. For orthopaedic implant prosthesis that have been re-classified from

Class IIb to Class III medical devices, annual report information must be submitted if the device meets either of the following criteria: I.The device was

subject to a TGA application audit based on revision rate when the device transitioned from Class IIb to Class III; and/or II.No devices were supplied to

the Australian marketplace before 30 June 2012. As per the standard automatic condition, annual reports should be submitted each year for the first

three years of inclusion as a Class III medical device on the ARTG.

Where a medical device included in the Register, contains a substance which is included in the Fourth Schedule to the Customs (Prohibited Imports)

Regulations or the Eighth Schedule to the Customs (Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the

medical device, be in possession of a licence and a permission for importation or exportation of each consignment of the goods as required by those

regulations.

A sponsor shall ensure that a medical device within their control is stored and transported in accordance with the instructions and information provided

by the manufacturer.

Manufacturers

Name

Address

Saiba Footware Pty Ltd

12 Thomas Drive

SURFERS PARADISE, QLD, 4217

Australia

Products

1. Orthosis, footwear, orthopaedic, shoe, <specify>

Product Type

Single Device Product

Effective date

31/01/2014

GMDN

31040 Orthosis, footwear, orthopaedic, shoe, <specify>

Intended purpose

A device, (insole) that is intended to treat/compensate for the structural or functional disorders of a

person's feet.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 06:38:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information