New Tyvek® materials: regulatory obligations
DuPont has announced an upgraded manufacturing process using flash spinning technology for two grades of Tyvek® (1073B and 1059B) including both coated and uncoated styles used in medical device packaging. This change will impact a large number of medical devices that are included on the Australian Register of Therapeutic Goods (ARTG).
In order to meet the conditions of inclusion on the ARTG, manufacturers transitioning from the existing Tyvek® 1073B or 1059B to the new Tyvek® 1073B or 1059B need to check that the performance and safety of their medical devices continue to meet the Australian Essential Principles (EPs).
What manufacturers should do
For all medical devices included on the ARTG, manufacturers should:
- Conduct a Risk Analysis to determine if the Tyvek® material change affects:
- packaging integrity at the product release stage, including sterile barrier integrity,
- packaging integrity during transport,
- the product shelf life, or
- the sterilisation of the product.
- Implement control procedures for the change as per the manufacturers' Quality Management System (QMS) and assess the level of impact. The assessment can be conducted using known information (i.e. Dupont's test results) and/or testing of the relevant medical device.
- Validate any changes to the manufacturing of the product that are required as a result of the new material.
- Document activities associated with this change in accordance with their QMS.
Medical devices with TGA conformity assessment certificates
Class III and active implantable medical devices
Depending on the result of the manufacturers' analysis of the effects of the DuPont change in Tyvek®, there are a number of obligations that should be met.
- Manufacturers are not required to notify the TGA or submit a change application if they find the new Tyvek has a negligible impact on their device packaging. However, all relevant documents, including the rationale for accepting the new Tyvek® material for product packaging, should be available to the TGA inspector at the next on-site inspection or on request by the TGA.
- If the manufacturer finds the new Tyvek has an extensive impact on device packaging, requiring other substantial changes to the product or QMS e.g. changes to product shelf life or the sterilisation of the product, the manufacturer should submit a substantial change application.
This will meet the requirement to notify the TGA of substantial changes under Section 41EJ of the Therapeutic Goods Act 1989.
Other medical devices
These devices may include Class IIb, Class IIa, or Class I devices. Notification to the TGA may not be required and the manufacturer may change the packaging configuration or sterilisation of the product, if required.
However, the relevant documents should be available to the TGA inspector at the next on-site inspection or on request by the TGA. These include but are not limited to:
- updated technical master files
- risk management reports, evaluation results for the change to the new Tyvek® material
- validation reports for the new packaging configuration.
If the change in packaging material results in a substantial change to the manufacturer's QMS, then the TGA should be notified.
Medical devices with CE certificates
The manufacturer should liaise with their relevant Notified Body who will have procedures in place to deal with the change in the Tyvek® material.
Useful links associated with the manufacturing change to DuPont's Tyvek® material
- Dupont: Are you ready?
- US FDA: Functional Equivalence of Transition Tyvek
- Health Canada: Notice to sterile medical device manufacturers: Health Canada Requirements for Manufacturers Relating to Manufacturing Change to Tyvek® 1073B and 1059B (pdf,215kb)
EU notified bodies