Medical Devices
Designation for conformity assessment of medical devices
Kvalitet a.d. is designated by the Serbian Ministry of Health as a conformity assessment body according to Rulebook on medical devices (MDD):
- Designation 515-01-09331/2019-06 dated January 8th 2020,
- Designation 515-01-03313/2021-06 dated April 16th 2021.
Our Scope of accreditation you can find here (in Serbian).
Our accreditation scope includes next subgroups of products:
- MD 0105 Inactive ophthalmic agents
- MD 0106 Inactive instruments
- MD 0202 Inactive orthopedic implants
- MD 0402 Dental materials
- MD 1102 Respiratory devices, including hyperbaric chamber devices for oxygen therapy, inhalation and anesthesia
- MD 1103 Devices for stimulation or inhibition
- MD 1104 Active surgical devices
- MD 1111 Software
- MD 1402 Devices using non-ionizing radiation
- MD 1403 Devices for hyperthermia/hypothermia
- MDS 7006 Medical devices in sterile condition
Application Forms
If you are interested in our medical certification services, please fill out the Questionnaire below and send it to us by email medicinskasredstva@kvalitet.co.rs.
Please note that completing the Questionnaire is not a formal application, but merely a form of interest in our services.
The procedure for conformity assessment of medical devices
The procedure for conformity assessment of medical devices is given in the next documents (in serbian):
Instructions for using certification documents and for informing about changes
Instructions for using the certification documents and for informing about the changes can be found in the following document:
Register of issued and valid certificates of medical devices
More information soon…