MDEC meeting 2005/3, 9 September 2005

Medical Device Evaluation Committee

Meeting report

The 2005/3 (8th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 9 September 2005. The main points of discussion included -

• The application by Q-Med (Sweden) Australia Pty Ltd for provision of a conformity assessment certificate for Restylane, Restylane Perlane, Restylane Sub Q, Restylane Touch, Deflux, Zuidex for the following use -
  • Restylane, Restylane Perlane, Restylane Sub Q and Restylane Touch for dermal implantation for the purpose of facial tissue augmentation;
  • Zuidex for the treatment of female urinary stress incontinence; and
  • Deflux for the treatment of vesico-ureteral reflux in children.
• The application by Tag Medical Pty Ltd for the provision of a conformity assessment certificate for the Mitroflow Pericardial Heart Valve for use as a replacement for malfunctioning native or prosthetic aortic valves.
• Proposal to develop a strategy for the publication of information on the TGA website relating to recalls and corrective actions concerning medical devices.
• Proposal to amend the legislation for the trans tasman agency to ensure that instrument cleaners containing materials of biological origin are regulated as class I products.
• Progress report on the draft communication strategy for the TGA's Medical Device Incident Report Investigation Scheme (IRIS).
• Update on the tender for a consultancy to assess the cost benefits of a national medical device tracking system.

The 2005/4 MDEC meeting is proposed for 9 December 2005.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions made by the Medical Device Evaluation Committee (MDEC) at its recent meeting. It should not be assumed that recommendations made to the TGA represent the decisions of the TGA.

Device registrations

MDEC resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.

Minutes of the previous meeting

RES NO. 2005/18

The minutes of the 2005/2 (7th) meeting of the Medical Device Evaluation Committee (MDEC) are accepted and ratified as a true record.

Communication strategy for medical device hazard alerts and recalls

RES NO. 2005/22

MDEC endorses the TGA's proposal to develop a strategy for the publication of information on the TGA website relating to recalls and corrective actions concerning medical devices.

Proposed changes to the requirements for devices containing material of animal origin and recombinant products under the Trans Tasman Agency Rules

RES NO. 2005/23

MDEC notes the TGA's proposal to amend the legislation to ensure that instrument cleaners containing materials of biological origin are regulated as class I products.

Report from the Medical Device Incident Review Committee (MDIRC)

RES NO. 2005/25

MDEC notes the progress of the draft communication strategy for the TGA's medical devices adverse event reporting scheme.

Report from the Implantable Medical Device Tracking Subcommittee (IMDTS)

RES NO. 2005/26

MDEC notes that the Data Management and Analysis Centre in Adelaide has been selected to undertake the consultancy to assess the cost benefit of a national medical device tracking system and that an interim report is expected to be available for consideration at the December MDEC meeting.

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