Important information regarding Part IX applications
COVID-19 response
We have been asked by the Department of Health and Social Care (DHSC) to restart the Part IX application process with immediate effect.
To accommodate the safe working of staff away from the office, a number of changes have been agreed with the DHSC and Part IX Drug Tariff Forum and we ask that all applicants follow these. Failure to do so, may result in the application not being processed, or being delayed.
This change to process will be treated as a pilot for a possible new way of working and we will be assessing the impact of these changes over the coming 12 months.
Thank you for your understanding.
Changes to process
First Stage
This remains unchanged.
Second Stage
Submit the final DT1A and B forms with e-signatures which can be scanned or in electronic form. You will be asked to send digital photographs of the product, and the detailed requirement will be contained in the email sent after the first stage has been completed.
Do not send samples unless specifically asked to do so. We cannot guarantee the safe handling of these and they will not be looked at.
Guidance to manufacturers and suppliers of medical devices
Use the DT1 application forms to apply to have a medical device listed in Part IX of the Drug Tariff.
Drug Tariff guidance (PDF: 256KB)Summary of process (Word: 207KB)DT1 Form A (Word:20KB)
DT1 Form B Class I Non-sterile medical devices (Word: 22KB)
DT1 Form B Class I Sterile medical devices (Word: 21KB)
DT1 Form B Class IIA medical devices (Word: 21KB)
DT1 Form B Class IIB medical devices (Word: 21KB)
DT1 Form B Class III medical devices (Word: 23KB)
DT1 Form B IV Diagnostics medical devices (Word: 29KB)
DT1 Form B Non CE marked medical devices (Custom made items or Deodorants) (Word: 88KB)DT2 Declaration for continued listing (Word: 20KB)DT3 Change of Product Listing (Word: 27KB)
Support and information with the application process
Email the Secretariat for the Part IX Drug Tariff forum at drugtariff@bhta.com.