+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

Establishment of marketing authorization

State registration (marketing authorization) of medical devices is performed by Ministry of Health of Ukraine on results of specialized expertise of quality, safety and efficiency of medical device. Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate for medical device is issued for 5 years and can be renewed before expiry.

Registration certificate can include several medical devices that have same of similar method of action, manufactured under same quality management system. Such devices are listed in Annex 1 to the registration certificate. All accessories, disposables, spare parts and other products supplied with medical device are listed in the Annex 2 to the registration certificate. 

Registration certificate can include several manufacturers. Relations between these manufacturers must be obviously explained by incorporation to one corporation, relevant contracts or license agreements.  

Additionally Application for marketing authorization of medical device include information on Applicant (owner) of registration certificate. Marketing authorization certificate is object of property right and belongs to the legal entity that applied for registration. Applicant can be any legal entity, resident or non-resident of Ukraine, manufacturer itself. 

Establishment of registration of medical device does not put any specific requirements to the manufacturer or applicant: there is no need to establish local representative office or legal entity; responsibilities of service and repair are usually performed by importers. 

Process of marketing authorization is initiated by submission of Application for registration with necessary documents (hereinafter - registration dossier). Registration dossier includes administrative documents provided by manufacturer(s), administrative documents and information on medical device that is subject to registration. 

We are ready to help you in filling the registration dossier according to local requirements, correct presentation of Application and annexes; by Power of Attorney we will submit registration materials to Ministry of Health of Ukraine and perform all required expertise and testing till issue of registration certificate. In fact - we will perform all required actions and works by ourselves, but continually informing you on progress and key issues. 

Список документов для регистрации медицинских изделий и техники в Украине

Dossier in MS Word

Our communication with Customer is usually performed in English language, we know necessary terminology and able to give obvious answers or ask understandable questions. We have a bank of different forms and examples that will make cooperation process much easier. 

Our experience and knowledge guarantee that registration procedure will be performed in most correct and fast way. 

Contracting us for medical device registration means that we will perform following works and services: 

  • We will provide you with all preliminary consulting, advices and explanations; 
  • We will assist you in preparation of necessary registration materials; 
  • We will perform translation of documents into russian or ukrainian language, notary certification of translations of official documents; 
  • We will develop Application form and Annexes; 
  • We will obtain conclusion on custom commodity code from Chamber of Commerce; 
  • We will submit finished dossier to Ministry of Health of Ukraine; 
  • We will manage all necessary state expertise; 
  • We will import samples of medical devices for studies (if necessary); 
  • We will manage all necessary issues prior to approval of medical device; 
  • We will check drafts of marketing authorization documents and will get your approval; 
  • We will obtain original marketing authorization certificate and deliver it to you. 
Establishment of marketing authorization | Cratia 2 Time to achieve registration of medical device is approximately one month (time of state expertise) from the date of submission of finished registration dossier to Ministry of Health till approval of medical device for registration in Ukraine. Before submission it is required to collect necessary documents, translate them, develop Application.

Total budget for establishment of registration of medical device depends on the object of registration, type of medical device, amount of products (modifications) registered under one certificate, safety class, particularities of medical device (such as sterility etc.). 

We will provide you with detailed calculation of the budget of state registration of chosen products after we will receive from you brochure, catalogue or any other information that will allow us to understand the object of registration.  

 

Of cource we provide all preliminary consulting and calculation of the budget 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 at our office.