Newly Added Features/Requirement Changes
MEDICAL DEVICE
When the product was queried with the supply barcode from the DMO service to the market, the product content was multiplied by the number and the amount in the package was also returned.
Device applications for custom-made medical devices with MDD/AIMD regulations that have been ‘Drafted’, ‘Ready to Apply’ or have been submitted but have been ‘Rejected’ before becoming registered have been blocked for all users except health service providers.
It was ensured that users of health service providers in the position of hospital supervisor could sign the application created for custom-made medical devices manufactured according to MDR regulations.
In order for the products under the branch type calibration authorization group to be added / updated without being subject to calibration, it was ensured that the relevant branch type, institution and product number could be defined with a special processing permission.
SSI ensured that the records of the C and D group sut code matching application periods were passivated and stored instead of being deleted from the database.
It was ensured that the original label files of medical devices in JPEG format could also be added to the system.
cosmetic
When adding components to the system, it was ensured that cosmetic components with october similar name INCI registered in the system could be brought.
The reference type filter has been added to the Ata page that examines the Cosmetic Application.
BIOCIDAL PRODUCTS
The necessary screens have been opened for Biocidal companies to register in the system.
The necessary screens have been opened for biocidal companies to add biocidal products and apply for licenses for biocidal products.
CLINICAL ENGINEERING
Calibration organization applications authorization certificate It was ensured that multiple selections could be made in branch type selection processes.
PGD
By adding a Unique Product tab to the medical device PGD and warning file detail, it was ensured that the location information of individual products in the system and company information where a single product may be available could be displayed.
The Enquiry menu has been removed and Overseas Notifications have been added instead.
Added the ability to add batch october with excel file to add/update reports for Periodic Summary Report, Field Safety Corrective Action Report and Manufacturer Adverse Event Report forms.
Improvements
MEDICAL DEVICE
The information about the other manufacturing institutions where the product was produced was removed from the product imprint.
It has been ensured that the lists of SUT codes that do not require a SUT match and the SUT codes that are required to be matched due to their exceptional status, although they are linked to these lists, can be managed by the SSI.
PGD
The listing/paging features in the Select Device Type window for the Inspected Product have been updated to improve the user experience.
Fixed Bugs
MEDICAL DEVICE
Fixed a bug where you could not add more than one storage/use condition of the same storage/use condition type in the device add/update windows.
Fixed an error that occurred when assigning a password to a certificate.
CLINICAL ENGINEERING
The error received when confirming the calibration training has been corrected.
Fixed a bug that prevented the “Technical Service Personnel Operations” menu from being displayed in some technical service companies.
Other (Jobs with a “Task" Type)
Various data corrections were made in accordance with the request of TITCK.
At the request of TITCK, various statistics were extracted.
The general powers used for statistical operations have been customized and redefined and listed under the heading ‘System Monitoring Operations’.
Source: https://uts.saglik.gov.tr/?p=3292
16 Dec 2021
