ArthroCare

Surgical Diathermy Systems

ARTG Certificate ArthroWands March 2011

ARTG Certificate

2 Pages

Australian Register of Therapeutic Goods Certificate Issued to  Arthrocare Australasia Pty Ltd for approval to supply  Arthrocare Australasia Pty Ltd - Electrode, electrosurgical, active, foot-controlled, single use ARTG Identifier  181714  ARTG Start date  31/03/2011  Product Category  Medical Device Included Class IIb  GMDN  35703  GMDN Term  Electrode, electrosurgical, active, foot-controlled, single use  Intended Purpose  The ArthroWands are indicated for resection, ablation and coagulation of soft tissue, hemostasis of blood vessels, wound debridement and soft tissue debridement.  Manufacturer Details  Address  Certificate number(s)  Arthrocare Corporation  7000 West William Cannon Drive Austin, TX, 78735-8531 United States Of America  DV-20080804-MC-059254-11  ARTG Standard Conditions The above Medical Device Included Class IIb has been entered on the Register subject to the following 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
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