Get Declaration Of Conformity Templates (medical Devices) - Tga

This guide provides clear and supportive instructions on how to fill out the Declaration Of Conformity Templates for medical devices according to the Australian Therapeutic Goods Administration regulations. Follow the steps provided to ensure all necessary components are addressed properly.

Follow the steps to complete your form online.

1. Click ‘Get Form’ button to access the Declaration Of Conformity Templates. This will open the form in your online editor where you can begin filling it out.
2. Enter the manufacturer's name in the designated field. This should reflect the official name of the entity responsible for the medical device.
3. Provide the business address of the manufacturer. Ensure that all details such as street address, city, state, and country are listed correctly.
4. List the medical devices covered by this declaration. Include the product names along with their specific reference numbers for precise identification.
5. Select the classification of the medical devices according to their intended use and associated risks, ensuring the correct class is indicated.
6. Fill in the GMDN code and term for each medical device to facilitate proper classification and regulations compliance.
7. Describe the scope of application for the devices, detailing their intended purpose and usage in medical contexts.
8. Reference the Full Quality Assurance Procedures certificate as it affirms the compliance of the product with relevant regulations.
9. Mention the standards applied for manufacturing and safety, ensuring all listed standards are relevant to the devices.
10. Sign and date the document in the section reserved for the authorized signatory, including their title and role.
11. Once all fields are filled, review the document for accuracy. You can then save your changes, download, print, or share the completed form.

Complete your Declaration Of Conformity Templates online today.