Renewal and changes to the registration certificate of medical device:

Any changes to registration certificate can be implemented by procedure of re-registration. Re-registration can be performed for following reasons:

Due to expiry of registration certificate (to extend validity of marketing authorization for the next 5 years).
Due to variations (amendments) to registration certificate, such as change of manufacturer(s), change of applicant, extension of list of modifications (adding new models, regents, disposables).

1. Re-registration due to expiry of registration certificate.
Certificate of state registration of medical device is valid for 5 years. Application for renewal of registration should be submitted not later than 90 days before the date of the expiry of registration certificate. After renewal validity of registration certificate will be prolonged for the next 5 years.

Applicant can implement changes (amendments) to registration documents during renewal of registration. For example, list of modifications that are presented in Annex to registration certificate can be extended during renewal without additional expenses.

Preliminary expertise of registration materials by State Inspection of regulatory policy;
Technical expertise of registration materials by specialized expert institution;
Approval of renewal at the session of State Inspection of regulatory policy;
Check of the draft and issue of renewed registration certificate;

Total time that is needed for re-registration is approximately 4 weeks from the moment of submission of Application to State Authority. Please note that preparation of the dossier can also take several weeks.

Total budget for re-registration due to expiry of validity of marketing authorization of medical device can vary from 2500 to 4500 EURO, depending on:

Mentioned above budget includes all state fees and state duties, services of Cratia Ltd.

2. Re-registration due to variations (amendments).
The most common reasons for applying for variations to registration certificate of medical device:

Extension of the list of modifications: adding new models to the listing (Annex);
Change of the name, address of manufacturer(s) or adding new manufacturer(s);
Change of the Applicant (marketing authorization holder) of registration certificate;
Change of specific properties of medical device (sterility, materials etc.);

Procedure of variations can be initiated at any time by submission of Application. Depending on type and content of changes (amendments) procedure can require specific expertise:

Preliminary expertise of registration materials by State Inspection of regulatory policy;
Technical expertise of registration materials by specialized expert institution;
Toxicological expertise can be needed in case of serious changes in listing of modifications or applying new properties of medical device;
Metrological expertise can be needed in case of changes to measuring properties of medical device;
Sterility expertise can be needed in case of extension of sterile models or applying sterility;
Medical (clinical) expertise can be needed in case of very serious changes to efficiency properties of medical device;
Approval of renewal at the session of State Inspection of regulatory policy;
Check of the draft and issue of renewed registration certificate;

Major types of variations do not require specific expertises that are highlighted by grey color above.

Total time that is needed for re-registration is approximately 3-5 weeks from the moment of submission of Application to State Authority. Please note that preparation of the dossier can also take several weeks.

Total budget for re-registration of marketing authorization of medical device can vary widely depending on type and content of variations from 2500 to 6000 EURO, depending on:

Type and content of changes, amendments;
Structure of registration dossier, amount of translations that will be needed;
Safety class of medical device;
List of modifications (Annex to registration certificate);
List of specific expertises required for re-registration.

Mentioned above budget includes all state fees and state duties, services of Cratia Ltd.

List of services that will be performed by Cratia Ltd. for re-registration of the medical device:

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 submit the Application and dossier, represent your interests in State Authorities on all stages and upon any questions of re-registration;
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;

If you are interested in services of our company in the field of re-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.