| Fees for state registration of medical devices and medical equipment | ||||
|---|---|---|---|---|
| № | Name of the work (service) performed | Unit of measurement | Price in BCA* | Price in USD |
| 1 | Review of the application and issuance of a registration certificate for medical devices and medical equipment under the general procedure: | |||
| 1.1 | Conducting primary (preliminary) expert examination of the application: | |||
| 1.1.1 | Class I medical devices | Per application | 8 | 275 |
| 1.1.2 | Classes IIa, IIb, and III medical devices | Per application | 10 | 343 |
| 1.2 | Conducting a specialised expert evaluation of registration documents, laboratory testing of samples, and making a decision on registration or refusal of registration: | |||
| 1.2.1 | Class I medical devices (excluding sterile, measuring, and invasive devices) | Per medical device | 28 | 961 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| if the device contains a consumable or a component that is also a medical device | Per each additional device | 28 | 961 | |
| a medical device manufactured at an additional production site | Per each additional device | 28 | 961 | |
| 1.2.2 | Class I medical devices (sterile, measuring and invasive medical device) by safety class | Per medical device | 45 | 1544 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| If the medical device is presented as a kit and/or modification | Per each additional device | 45 | 1544 | |
| a medical device manufactured at an additional production site | Per each additional device | 45 | 1544 | |
| 1.2.3 | Class I in vitro diagnostic medical devices | Per medical device | 44 | 1509 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| if the device contains a consumable or a component that is also a medical device | Per each additional device | 44 | 1509 | |
| a medical device manufactured at an additional production site | Per each additional device | 44 | 1509 | |
| 1.2.4 | Class IIa medical devices | Per medical device | 50 | 1715 |
|
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| if the device contains a consumable or a component that is also a medical device | Per each additional device | 50 | 1715 | |
| a medical device manufactured at an additional production site | Per each additional device | 50 | 1715 | |
| 1.2.5 | Class IIa in vitro diagnostic medical devices | Per medical device | 50 | 1715 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| if the device contains a consumable or a component that is also a medical device | Per each additional device | 50 | 1715 | |
| a medical device manufactured at an additional production site | Per each additional device | 50 | 1715 | |
| 1.2.6 | Class IIb medical devices | Per medical device | 53 | 1818 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| if the device contains a consumable or a component that is also a medical device | Per each additional device | 53 | 1818 | |
| a medical device manufactured at an additional production site | Per each additional device | 53 | 1818 | |
| 1.2.7 | Class IIb in vitro diagnostic medical devices | Per medical device | 52 | 1784 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| If the medical device is presented as a kit and/or modification | Per each additional device | 52 | 1784 | |
| a medical device manufactured at an additional production site | Per each additional device | 52 | 1784 | |
| 1.2.8 | Class III medical device | Per medical device | 54 | 1852 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| If the medical device is presented as a kit and/or modification | Per each additional device | 54 | 1852 | |
| a medical device manufactured at an additional production site | Per each additional device | 54 | 1852 | |
| 1.2.9 | Class III in vitro diagnostic medical devices | Per medical device | 53 | 1818 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| If the medical device is presented as a kit and/or modification | Per each additional device | 53 | 1818 | |
| a medical device manufactured at an additional production site | Per each additional device | 53 | 1818 | |
| 2 | Registration (re-registration) under the recognition procedure, as well as registration (re-registration) of in vitro diagnostic medical devices (IVD) prequalified by the WHO or registered in collaboration with the WHO: | |||
| Conducting primary (preliminary) expert examination of the application | Per application | 8 | 275 | |
| 2.2 | Conducting specialized expert evaluation of the registration dossier and making a decision on registration or refusal of registration: | |||
| 2.2.1 | Class I medical devices | Per medical device | 28 | 961 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| 2.2.2 | Class IIa medical devices | Per medical device | 31 | 1064 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| 2.2.3 | Class IIb medical devices | Per medical device | 37 | 1269 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| 2.2.4 | Class III medical devices | Per medical device | 38 | 1304 |
If the medical device is presented as a kit and/or modification:
|
Per kit, and/or modification |
|
|
|
| 3 | Consideration of an application for an extension of the validity period of a medical device registration certificate in accordance with the general procedure and issuance of a certificate (without laboratory tests): | |||
| 3.1 | Conducting primary (preliminary) expert examination of the application | in the amounts specified in items 1.1.1–1.1.2 | ||
| 3.2 | Conducting specialized expert evaluation of the registration documents, and making a decision on registration or refusal of registration: | |||
| 3.2.1 | Class I medical device | Per medical device | 28 | 961 |
| 3.2.2 | Class IIa medical device | Per medical device | 31 | 1064 |
| 3.2.3 | Class IIb medical device | Per medical device | 34 | 1166 |
| 3.2.4 | Class III medical device | Per medical device | 35 | 1201 |
| 4 | Consideration of the application for extension of the validity period of the certificate of registration of the medical device and issuance of the certificate (with laboratory tests) | Per medical device | in the amounts specified in item 1.2 | |
| 5 | Variations (amendments and additions) to the medical device registration documents | |||
| 5.1 | For medical devices of classes I, IIa, IIb, and III by risk level — in cases where laboratory testing is not required | Per medical device | 30% of the fee specified in item 1.2 | |
| 5.2 | For medical devices of classes I, IIa, IIb, and III by risk level — in cases where laboratory testing is required | Per medical device | 50% of the fee specified in item 1.2 | |
Notes:
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