Australia’s Therapeutic Goods Administration is pausing plans to implement new regulatory changes intended to manage devices and products produced through the use of additive manufacturing, according to a new report from the Regulatory Affairs Professionals Society.
The decision to delay the regulatory changes came after the agency received a number of comments asking for clarifications, according to the report.
The TGA reportedly received a total of 24 comments on the changes, with 15 coming from industry groups including trade associations and major players in the medtech field.
Requests included clarity on the differences between custom-made devices and patient-centric devices and the inclusion of anatomical models, according to RAPS.
“The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change,” the TGA wrote in a notice, according to the report. “The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions.”
Industry stakeholders also opposed proposed limitations on the number of custom-made devices a manufacturer can supply annually, according to RAPS, and voiced concerns about the defined differences between a manufacturer and a production environment.
About half of the comments agreed with the changes while the other half raised issues and sought further clarification, according to the report.
Stakeholders had positive things to say about a number of newly proposed regulations, including changes to custom-made device conformity assessment procedures, inspections of custom-made device manufacturing sites and the regulation of scaffolds containing human-originated materials, RAPS reports.
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