Tga Medical Device Contact

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Medical devices & IVDs | Therapeutic Goods …

https://www.tga.gov.au/medical-devices-ivds

[email protected]

Contact us | Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/about-tga/contact-us

Our contact details Simple enquiries may be answered quickly by phone. Enquiries that are more complex may need to be sent by email. Telephone We are here Monday to Friday, …

Medical devices | Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/products/medical-devices

The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are …

Overview of medical devices and IVD regulation

https://www.tga.gov.au/overview-medical-devices-and-ivd-regulation

Medical device inclusion process | Therapeutic Goods …

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good-0/supply-medical-device/medical-device-inclusion-process

Accessing TGA Business Services You will need to have a Client ID and access to the TGA Business Services (TBS) website in order to submit your medical device application. …

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

The TGA has mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. These requirements facilitate the …

Is my product a medical device? | Therapeutic Goods …

https://www.tga.gov.au/resources/my-product-medical-device

If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you …

Medical device application processing times

https://www.tga.gov.au/resources/resource/guidance/medical-device-application-processing-times

The TGA processing times for conformity assessment applications and applications for inclusion on the ARTG are calculated using the TGA Half-yearly Performance Snapshot 2 …

TGA Guidance on Reclassification of Medical Devices in Direct …

https://www.regdesk.co/tga-guidance-on-reclassification-of-medical-devices-in-direct-contact-with-the-heart-ccs-and-cns/

The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document …

Database of Adverse Event Notifications - medical devices

https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

Contact the TGA Safety information Product recalls Alerts Early warning system Reporting problems Safety information & education Consumers Consumer information & education …

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