| 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 | 277 |
| 1.1.2 | Classes IIa, IIb, and III medical devices | Per application | 10 | 346 |
| 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 | 967 |
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 | 967 | |
| a medical device manufactured at an additional production site | Per each additional device | 28 | 967 | |
| 1.2.2 | Class I medical devices (sterile, measuring and invasive medical device) by safety class | Per medical device | 45 | 1554 |
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 | 1554 | |
| a medical device manufactured at an additional production site | Per each additional device | 45 | 1554 | |
| 1.2.3 | Class I in vitro diagnostic medical devices | Per medical device | 44 | 1519 |
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 | 1519 | |
| a medical device manufactured at an additional production site | Per each additional device | 44 | 1519 | |
| 1.2.4 | Class IIa medical devices | Per medical device | 50 | 1726 |
|
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 | 1726 | |
| a medical device manufactured at an additional production site | Per each additional device | 50 | 1726 | |
| 1.2.5 | Class IIa in vitro diagnostic medical devices | Per medical device | 50 | 1726 |
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 | 1726 | |
| a medical device manufactured at an additional production site | Per each additional device | 50 | 1726 | |
| 1.2.6 | Class IIb medical devices | Per medical device | 53 | 1830 |
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 | 1830 | |
| a medical device manufactured at an additional production site | Per each additional device | 53 | 1830 | |
| 1.2.7 | Class IIb in vitro diagnostic medical devices | Per medical device | 52 | 1795 |
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 | 1795 | |
| a medical device manufactured at an additional production site | Per each additional device | 52 | 1795 | |
| 1.2.8 | Class III medical device | Per medical device | 54 | 1864 |
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 | 1864 | |
| a medical device manufactured at an additional production site | Per each additional device | 54 | 1864 | |
| 1.2.9 | Class III in vitro diagnostic medical devices | Per medical device | 53 | 1830 |
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 | 1830 | |
| a medical device manufactured at an additional production site | Per each additional device | 53 | 1830 | |
| 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 | 277 | |
| 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 | 967 |
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 | 1070 |
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 | 1278 |
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 | 1312 |
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 | 967 |
| 3.2.2 | Class IIa medical device | Per medical device | 31 | 1070 |
| 3.2.3 | Class IIb medical device | Per medical device | 34 | 1174 |
| 3.2.4 | Class III medical device | Per medical device | 35 | 1209 |
| 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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Class 1 (or Class I) medical devices are low-risk, non-invasive products posing minimal potential harm to patients, such as bandages, stethoscopes, surgical masks, and manual wheelchairs. They rarely support life and are subject to general controls by regulatory bodies like the FDA, with most being exempt from premarket notification.
Class 2a (or Class IIa) medical devices are moderate-risk products under EU regulations (MDR 2017/745) that are typically used on the body for a short duration (typically 60 minutes to 30 days). These devices, including catheters, dental fillings, and diagnostic monitors, require a Notified Body's involvement for conformity assessment to ensure safety.
Class 2b (or Class IIb) medical device is a medium-to-high risk device, often defined under EU MDR 2017/745 as devices that monitor vital functions or are invasive for long-term use, such as ventilators, dialysis equipment, and implantable devices. These require rigorous conformity assessment by a Notified Body, extensive clinical evidence, and quality system certification (e.g., ISO 13485).
Class 3 (or Class III) medical devices are the highest-risk category, defined as devices that support or sustain human life, are implanted, or present a potential unreasonable risk of illness or injury. These devices require the most stringent regulatory oversight, typically demanding Premarket Approval (PMA) from the FDA to prove safety and efficacy before marketing.
In vitro diagnostic medical devices (IVDs) are tests, instruments, software, and reagents used on biological samples (like blood or tissue) to assess health, diagnose diseases, and monitor patient conditions. They are used in vitro (outside the body), ranging from lab analyzers to self-tests, and are categorized by risk.
In vitro diagnostic medical devices (IVDs) are tests, instruments, software, and reagents used on biological samples (like blood or tissue) to assess health, diagnose diseases, and monitor patient conditions. They are used in vitro (outside the body), ranging from lab analyzers to self-tests, and are categorized by risk.