What is the ACMD and why should I be interested?

What is the ACMD and why should I be interested?

The ACMD stands for the Advisory Committee on Medical Devices, a committee which provides independent medical and scientific advice to the Minister and the Therapeutic Goods Administration (TGA) on safety, quality and performance of medical devices supplied in Australia including issues relating to premarket conformity assessment and post market monitoring. The Committee is established under Regulation 38 of the Therapeutic Goods Regulations 1990 and the members are appointed by the Minister for Health and Ageing.

ACMD review applies to most Class III medical device conformity assessment applications and their advice can have a key impact on obtaining TGA certification for your medical device.  Reports are provided to the ACMD members from TGA assessors (delegates) outlining their review of previously submitted conformity assessment documentation.

As part of the ACMD review process manufacturers are given the opportunity to review the assessor’s reports and provide a limited amount of additional information. This information must be submitted in the form of a pre-ACMD response. The pre-ACMD response will be part of the package submitted to the ACMD for consideration.

The ACMD meet on a quarterly basis and the meeting schedule can be found on the TGA website. Their resolutions and reports are also published on the TGA website.

For further information regarding ACMD processes, conformity assessment for medical devices, or product registration in Australia, contact KD&A.