TGA consults on proposed changes to pre-market assessment for medical devices

The Therapeutic Goods Administration has proposed changes to the premarket assessment requirements in its consultation paper released in January.

The Therapeutic Goods Administration (TGA) has proposed changes to the pre-market assessment requirements in its consultation paper released in January, which focuses on the two key elements of the premarket assessment process: conformity assessment and approval for marketing through inclusion on the Australian Register of Therapeutic Goods (ARTG).

This paper details the following proposals:

• Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion;
   
• Proposal B: Publication of medical device regulatory decisions; and
   
• Proposal C: Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower class medical devices.

The case for reform is based on a number of reports and inquiries, which have emphasised the need to increase the rigour of the TGA’s premarket assessment process for higher risk medical devices, in particular implantable medical devices.

The TGA says the consultation paper addresses the recurring themes in recent reports and inquiries, such as the TGA Blueprint for Reform (December 2011) and the two Senate inquiries into medical device regulation which were conducted in 2011-12.

AusBiotech/AusMedtech will be making a submission. AusBiotech members wishing to contribute to the AusBiotech submission are invited to direct comments to be included to Alina Tooley, National Manager Programs, or on +61 3 9828 1425 by 7 March 2013.

Responses may also be made directly by close of business Friday 15 March 2013.

The discussion paper and the full details of the consultation process can be found here.