+38 044 332-42-94,
+38 044 221-71-29,
Medical devices
— Market requirements for medical devices
— Establishment of marketing authorization
— Renewal of registration and changes
— Dossier structure (necessary documents)
— State registry of medical devices
— Sanitary epidemiological conclusion
— Certification of medical devices
— Ukrainian legislation
— Portfolio

Renewal of registration and changes

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, modifications, disposables).

We are ready to assist you in re-registration (renewal) process: we will answer all your questions, give you advices and explanations, we will fill in the registration dossier, develop the Application form and Annexes; we will represent your interests in state authorities by Power of Attorney, we will submit all registration materials to Ministry of Health of Ukraine and will organize state expertise and all studies till issue of regsitration certificate. In fact we will perfrom all necessary actions ourselves, with your approval on all key issues.   

1. Renewal: re-registration due to expiry of registration certificate (extention of the validity of the certificate for the next 5 years). 

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 extended for the next 5 years.

 Renewal of registration and changes | Cratia

Applicant should consider that list of necessary documents (registration dossier) for renewal of registration is the same as for new registration. Thus we must submit full registration dossier; general requirements for legalization are applied to administrative materials. We advice to start filling the dossier in 6-7 months before expiry f registration certificate. 

Applicant can implement/introduce changes (amendments) in the registration documents during renewal of registration. Therefore it should be considered:

  • minor changes will not effect re-registration process, it's timing and budget; 
  • serious changes or amendments, such as extension or update of products list, adding new manufacturing site etc. can lead to necessity of additional studies during state expertise; 

In case if no serious changes are applied, procedure of expertise will be done in following steps:  

  • Preliminary expertise of registration materials by State Authority;
  • Technical expertise of registration materials by specialized expert institution;
  • Approval of renewal at the session of State Authority;
  • Approval of the drafts of registration certificate and issue of renewed document;

Total time that is needed for re-registration is approximately 2 weeks from the moment of submission of Application to State Authority till approval of the product on the session. Please note that preparation of the dossier can also take several weeks.

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);

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. Main steps of re-registration process are: 

  • Preliminary expertise of registration materials by State Authority;
  • 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 (substantial/major) changes to efficiency properties of medical device;
  • Approval of re-registration at the session of State Authority;
  • Check of the draft and issue of renewed registration certificate;

List of documents for re-registration is the same as for new registration, plus specific documentation regarding applied changes.  

Total time that is needed/required for re-registration is approximately 2-5 weeks from the moment of submission of Application to State Authority. Please note that preparation of the dossier can/may also take several weeks.

 

Budget for re-registration of medical device can seriously vary depending on scope of work that should be done: necessity of translations, type and content of changes etc. To define budget we need to receive from you exact information regarding re-registration process.  

It is obvious that all preliminary advices and consulting are free of charge. 

 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.