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Self-declaration to Technical regulations

Self-declaration is applied to following classes of medical devices:

  • Medical devices of I class, not sterile, without measuring functions according to provision of Technical regulation on medical devices (Decree of CMU №753);
  • Analyzers, reagents and other IVD products, which are not included in the lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754);
Self-declaration to Technical regulations  | Cratia

Read our article: The new requirements for placement of medical devices on the market of Ukraine: conformity assessment according to the Technical Regulations

Such devices do not require submission of documents or any expertise procedures, except notifying the State Administration of Ukraine on Medical Products. To achieve conformity of relevant medical devices to national Technical regulations it is necessary to:

  • Designate the Authorized representative of the manufacturer in Ukraine and complete all related legal formalities;
  • Fill the technical documentation in accordance with the requirements of relevant national Technical regulation and applicable procedure;
  • Translate specific parts of technical documentation into Ukrainian;
  • Issue the Declaration of Conformity to Technical regulations of Ukraine;
  • Submit a notification with the authorized representative’s name, address and medical devices list to the State Administration of Ukraine on Medical Products;
  • Affix the symbol of national conformity, name and address of Authorized representative at the labeling of medical device, check compliance of the requirements for labeling and instruction for use (user's manual); 

The Declaration of Conformity actually replaces the state registration certificate at the customs clearance for medical devices under self-declaration procedure. Attention should be paid to the fulfillment of all the requirements and formalities imposed on the authorized representative, as medical devices become the subject of the market supervision from the moment of their admission into the customs territory of Ukraine. The Authorized representative must keep all the documentation and provide access to it upon the request of the State Administration.

 

“Cratia” offers services of self-declaration of conformity assessment on Technical regulations. We have the necessary knowledge, experience and skills to carry out all the necessary works and activities. We will take responsibility for organization of the process and perform it in the shortest possible time. We provide:

  • all necessary consultations regarding the requirements of Technical regulations, list of necessary documents and their legalization requirements, scientific advices etc .;
  • the professional expertise of the documentation;
  • individually designed for our partners bilingual (Ukrainian-English) text of the Agreement on designation of Authorized representative in Ukraine;
  • translations of necessary documents, including proofreading and notary certification if required;
  • filling the documents according to legal requirements; 
  • localization of package labeling and instruction for use (manual);
  • drafting of Declaration of conformity to Ukrainian Technical regulations. 

 

All preliminary consulting and advices are free of charge, do not hesitate to contact us by e-mail info@cratia.ua, tel. +38 (044) 332-42-94 or visit our office