Introduction, general information:

Introduction & general information:

Obligatory requirement for import and sale of the medical devices in Ukraine is a state authorization (registration). State Agency responsible for registration of the medical device is a State Inspection of quality of medicinal products and products of medical purpose of Ministry of Health of Ukraine (hereinafter – State Inspection). State Inspection has taken responsibilities for expertise and approval of marketing authorizations for medical devices from State Department of regulatory policy of medicinal products and goods in healthcare area in March 2010 (due to the Decree of Cabinet of Ministers No. 275 as of 17.03.2010).

Registration certificate for medical device is valid for 5 years for the date of state registration.
Registration certificate consist from two parts:

Registration certificate itself (includes number & date, date of expiry, name of medical device, custom commodity code that should be applied to the device with all modifications, safety class of the device).
Annex to registration certificate that includes listing of all modifications (type, size, color, version etc.) of medical device and accessories (parts, disposables, regents etc.) that are supplied with medical device

Application for renewal of registration should be submitted not earlier than 120 and not later than 90 days.

Following particularities can be applied to different types of medical devices:
Taxation: devices that are free of VAT tax and devices that are objects of VAT tax;
State purchases: general group of devices and devices that can be purchased on state tenders;
Types: general group of medical devices, devices for in-vitro diagnostic (IVD), active implants;
Safety class: class I, class IIa, class IIb, class III;
Custom commodity code: classification is performed upon group, type and way of use of medical device;

New registration of medical device requires following steps to be done (in brief):
1. Translation and preparation of the dossier, preparation of the Application and Annex (with listing of all modifications);
2. Receipt of the decision of the Chamber of commerce of Ukraine regarding custom commodity code for the device. Correct code should be chosen in order to avoid problems during custom clearance. Custom commodity code determines if the medical device will be free from VAT tax or not.
3. Submission of the Application and the dossier to the State Inspection.
4. Preliminary expertise of the dossier (presence of all documents).
5. Technical expertise of the registration materials: detailed expertise of registration dossier.
6. Safety (preclinical, toxicological) studies: expertise of safety of medical device.
7. Specific studies (for some types of medical devices): sterility studies, measuring (metrological) studies etc.
8. Efficiency (medical, clinical): expertise of examination of efficiency of medical device.
9. After positive conclusions from all studies a medical device is included to the log of nearest session of State Department.
10. Inclusion of medical device to the State registry of medical devices, issue of the original registration certificate and Annexes.

Session of the State Inspection is held every two weeks.

With our assistance procedure of state registration of your medical device in Ukraine will be very easy, performed professionally and quick.

With us you will receive:

all necessary consulting service regarding structure of registration dossier, requirements of legislation, legalization of the documents, advices regarding custom commodity codes, devices that are under VAT tax, particularities of the registration procedure etc.;
the most professional pre-registration expertise of the dossier, filling the Application and Annex;
drafts and examples of the documents, internal guidelines on preparation and presentation of the dossier;
translations, including notary certification of required documents, of necessary parts of the dossier;
we will represent your interests in State Authorities in all issues related with registration expertise;
we will take care of the import of samples (if needed), we are officially authorized by Kiev Central, Kiev-Boryspil and Ukrainian Central custom offices;
we will answer on questions of state experts or will carefully send them to you; we control the terms and deadlines;
we will make the pre-approval expertise of the draft of registration certificate and Annex;
original registration certificate with Annexes, plus one notary certified copy (that will be needed for your importer), in the shortest terms will be sent to you by World Courier;

We provide all preliminary consulting for free – please do not hesitate to contact us.

If you are interested in services of our company in the field of state registration of the medical device – you can find the following additional information at our website:

Marketing license and state registration of medical devices, health instruments, healthcare equipment in Ukraine. Regulatory affairs on medical devices, approval of marketing permission on medical device. Ukraine, Kiev, Cratia Ltd. Marketing approval, regulatory affairs on medical devices, medical and healthcare goods in Ukraine. State registration of medical devices. Ukraine, Kiev, Cratia Ltd.