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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 :

  1. Make sure you have a firm arrangement of supply  with the manufacturer.
  2. Ask your manufacturer to supply you with their updated and current CE certifications and assessment documents 
  3. Make sure you have a declaration of manufacturers conformity.  If you are to be audited, you will need a declaration to the Australian standard.
  4. see the link for current declaration templates:
  5. Be an Australian permanent resident and or citizen.
  6. Make sure you know the class of the devices being supplied.
  7. Make sure that you have all the data required by the TGA to substantiate your device application prior to initiating any process.
  8. If you are needing a conformity assessment make sure that you have a design examination certificate.
  9. If running a clinical trial be sure that you not only have ethics, that you following the clinical trials requirements.
  10. Always tell the truth to the TGA and your agent.
  11. Never make a false declaration as the consequences can be expensive.
  12. Never second guess what you need to do always ask for clarification.
  13. 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.
  14. If you have software within your device then please advise.
  15. Understand the transition to MDD to MDR.

Overall: Work with some one who knows the system, the device regulations, your requirements and is passionate about what we do!