MDEC meeting 2005/1, 18 March 2005

Medical Device Evaluation Committee

Meeting report

The 2005/1 meeting of the Medical Device Evaluation Committee (MDEC) was held on 18 March 2005. The main points of discussion included -

• The application for provision of a conformity assessment certificate for SMARTSET GHV Gentamicin Bone Cement from DePuy Pty Ltd (Australia) for use specifically for the seating and securing of metal or plastic prostheses to living bone;
• The application for provision of a conformity assessment certificate for the Three Piece CollamerTM Intraocular Lens Model CQ2003V from Concept Vision Australia Pty Ltd for use specifically for the treatment of aphakia in adult patients;
• The application for registration of the Nucleus Freedom Speech Processor (including Nucleus Freedom BTE Controller) from Cochlear Ltd for use specifically in controlling and directly influencing an active implantable medical device, a cochlear implant.
• The process for MDEC consideration of applications outside formal meetings;
• Response from Industry to the proposal for the reclassification of joint implants.

The 2005/2 MDEC meeting is proposed for 17 June 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 Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

Minutes of the previous meeting

RES NO. 2005/2

The Minutes of the 2004/3 meeting of the Medical Device Evaluation Committee are accepted and ratified as a true record.

MDEC consideration of applications outside formal meetings

RES NO. 2005/8

MDEC agreed on the process proposed by the TGA for dealing with medical device applications outside formal MDEC meetings.

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