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Guidance for Declaration of Conformity for Class I nonsterile nonmeasuring, Class 1 in vitro diagnostic (IVD) medical devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export

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How to fill out tga declaration of conformity

01

Download the TGA declaration of conformity form from the Therapeutic Goods Administration website.

02

Fill out the form with the required information including product details, conformity assessment details, and manufacturer details.

03

Sign and date the form to attest to the accuracy of the information provided.

04

Submit the completed form to the TGA along with any supporting documents as necessary.

Who needs tga declaration of conformity?

01

Manufacturers or sponsors of therapeutic goods who intend to supply their products in the Australian market need to provide a TGA declaration of conformity.

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What is tga declaration of conformity?

The TGA declaration of conformity is a document that confirms a medical device meets the regulatory requirements and standards set by the Therapeutic Goods Administration (TGA) in Australia.

Who is required to file tga declaration of conformity?

Manufacturers and sponsors of medical devices are required to file TGA declaration of conformity.

How to fill out tga declaration of conformity?

To fill out the TGA declaration of conformity, the manufacturer or sponsor must provide detailed information about the medical device, its intended use, evidence of conformity with regulatory requirements, and contact information.

What is the purpose of tga declaration of conformity?

The purpose of TGA declaration of conformity is to ensure that medical devices meet the necessary safety and performance standards before they can be supplied in the Australian market.

What information must be reported on tga declaration of conformity?

The TGA declaration of conformity must include information about the medical device, its classification, conformity assessment procedure, evidence of conformity, labelling information, and contact details.

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