MDEC meeting 2006/3, 15 September 2006

Medical Device Evaluation Committee

Meeting report

The 2006/3 (11th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 15 September 2006. The main points of discussion included -

• an application by Straumann Pty Ltd for the provision of a conformity assessment certificate for the Emdogain Enamel Matrix Derivative to be used for topical application to the exposed root surface of the tooth in conjunction with periodontal flap surgery to provide regeneration of tooth support lost due to periodontal disease or trauma.
• an application by William A Cook Australia Pty Ltd for the provision of a conformity assessment certificate for Sydney IVF Solutions for use by medical practitioners during the In Vitro Fertilization (IVF) process.
• an application by Gytech Pty Ltd for the provision of a conformity assessment certificate for the IVF Products for Assisted Reproduction for use by medical practitioners during the In Vitro Fertilization (IVF) process.
• an application by Vitrolife Pty Ltd for the provision of a conformity assessment certificate for the Vitrolife Sweden AB GIII Series IVF Media for use by medical practitioners during the In Vitro Fertilization (IVF) process.
• considered activity reports from the MDEC subcommittees.
• proposed new regulatory framework for human cells, tissues and cellular and tissue-based products.
• informed of the proposed new expert advisory committee under the Australia New Zealand Therapeutic Products Authority.

The 2006/4 MDEC meeting is proposed for 15 December 2006.

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. 2006/11

The minutes of the 2006/1 (10th) meeting of the Medical Device Evaluation Committee (MDEC) are accepted and ratified as a true record.

Report from the Medical Device Incident Review Committee (MDIRC)

RES NO. 2006/16

MDEC notes the report from the Medical Device Incident Review Committee and requested that the committee consider the feasibility of sentinel studies to gauge the extent of adverse events and implementation strategies.

Report from the Implantable Medical Device Tracking Subcommittee (IMDTS)

RES NO. 2006/17

MDEC notes that the Implantable Medical Device Tracking Subcommittee has reviewed a draft consultancy report on a national tracking system for medical devices and has provided comments on the report to the consultant. A final report is expected to be available in November 2006.

Report from the Bioengineering & Biomaterials Committee (BBC)

RES NO. 2006/18

MDEC notes the outcomes from the BBC's discussions on IVF Media and recommends that the BBC develop guidelines on the minimal requirements for IVF solutions in consultation with the National Pathology Accreditation Advisory Council (NPAAC) and the Reproductive Technology Accreditation Committee (RTAC).

Top of page