TGA Encourages Sponsors to provide Additional Information in Medical Device Application Cover Letters
The Therapeutic Goods Administration (TGA) now encourages sponsors to provide additional information in a cover letter to be submitted together with the medical device application in the TGA eBusiness Services online portal. While not a mandatory requirement, providing this information is expected to assist in the efficient assessment and processing of applications.
Recommended Cover Letter Content
Sponsors are encouraged to address the following points:
- Scope of the application
– Clarify whether the application relates to a single device, system, or procedure pack, and list all components where relevant. - Device functionality
– Provide a brief explanation of how the device functions, particularly where this is not evident from the GMDN term or stated intended purpose. - Classification rule and rationale
– Identify the classification rule applied under the Therapeutic Goods (Medical Devices) Regulations 2002 and outline any relevant reasoning or considerations that informed the classification. - For non-IVD medical devices:
– Indicate whether the device is invasive, and if so, specify the duration of use.
– If surgically invasive, confirm whether the device is in direct contact with the central nervous system (CNS) or central circulatory system (CCS).
– Evaluate whether any of the special rules under Part 4 or Part 5 of Schedule 2 apply. - For IVD medical devices:
– Provide a concise device description.
– Specify the intended use setting .
– Include any background information that may assist the TGA in evaluating the application.
What This Means for Sponsors
Although this additional information is not mandatory, including this detail will help the TGA better understand the device and its regulatory context, potentially minimising follow-up queries and delays during application evaluation.