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What are your keys to success with Device Inclusions?
The main keys to your success with you new venture will be :
- Make sure you have a firm arrangement of supply with the manufacturer.
- Ask your manufacturer to supply you with their updated and current CE certifications and assessment documents
- Make sure you have a declaration of manufacturers conformity. If you are to be audited, you will need a declaration to the Australian standard.
- see the link for current declaration templates: https://www.tga.gov.au/form/declaration-conformity-templates-medical-devices
- Be an Australian permanent resident and or citizen.
- Make sure you know the class of the devices being supplied.
- Make sure that you have all the data required by the TGA to substantiate your device application prior to initiating any process.
- If you are needing a conformity assessment make sure that you have a design examination certificate.
- If running a clinical trial be sure that you not only have ethics, that you following the clinical trials requirements.
- Always tell the truth to the TGA and your agent.
- Never make a false declaration as the consequences can be expensive.
- Never second guess what you need to do always ask for clarification.
- If you are supplying any implantable device, including dental implants make sure you have the capacity to prepare and submit yearly reports to the TGA about the device inclusion.
Overall: Work with some one who knows the system, the device regulations, your requirements and is passionate about what we do!