Register Product medical destination

Register Product medical destination

All operations with medical products on the territory of Ukraine, such as: Import, sale and use is allowed only after it’s registration. The procedure of state registration includes a number of examinations and tests on the safety and effectiveness of such medical product. Upon completion of registration, you will receive a permanent registration certificate.

Medical products are - appliances, systems, equipment, apparatus, instruments, devices, implants, supplies, materials or other articles, including invasive medical products, medical devices for the diagnosis in vitro, medical devices, that do not reach the intended target in or on the human’s body by pharmacological, immunological or metabolic facilities but such products can contribute to the aforementioned functions. Medical products, which are used either separately or in combination with each other, including software necessary for its proper use, to ensure :

  • • prevention, diagnosis, treatment, observation or facilitate the patient in the event of illness, injury, disability or recovery;
  • • achievements, replacement or modification of the structure (anatomy) of organs, tissues, or physiological processes;
  • • Control of the fertilization process.
    • Caution! If the composition of the medical product include a drug, the period of validity of the certificate is limited to a period of drug registration in Ukraine.

      Up to 20.06.2012g certificates were issued for some period, if you want such certificate be termless you should re-registrate it.

      Certificate of state registration - a document confirming the state registration of the product in Ukraine/ Such certificate permits import, use and disposal of your medical product in Ukraine, and also confirms the safety and effectiveness of medical devices, allows its use in medical practice.

      The certificate contains the following information:

      • • The number and date of issuance of the certificate;
      • • Name of the product and the class of security;
      • • Its validity;
      • • The application, which indicates modification of products and accessories in the form of related products and consumables.
        • Applicant will be the owner of the certificate, which can be a non-resident of Ukraine. The applicant is in this case can be a representative of the manufacturer or the manufacturer itself.

          All this information about all of the valid certificates and their owners is contained in special register which situated on the website of the State Drug Service. Their address in the internet is - www.diklz.gov.ua.

          If you want to begin registration, you should submit an application and attach to such application a number of properly issued documents. This package is called the registration dossier.

          The registration dossier consists of the documents described below, but this list is generalized. There could be situations when the composition of profile is different from that presented herein.

          • 1.Application form.
          • 2.Appendix: List of all modifications, models, parts, disposables that will be supplied as the part of medical device or with for medical device after its registration.
          • 3.The electronic version of the application form (1) and all Appendixes (2) submitted for state registration with the numbers according to the directory (in Ukrainian and English languages).
          • 4.Instructions for use, user’s manual, technical characteristics.
          • 5.Brochure (description of the device with a photo) or catalogue of devices.
          • 6.Certificate of origin issued on the headed paper of manufacturer (Exportation certificate or Free sales certificate).
          • 7.Certificate of State registration of medical devices in manufacturer’s country.
          • 8.Certificates of registration from other CIS countries (if there is a).
          • 9.Certificate of state registration of manufacturer(s) legal entity (usually that document is issued by Chamber of Commerce).
          • 10.CE Certificate of compliance to Directive 93/42/ЕЕС or relevant Directive for IVD (Declaration of conformity with mentioned safety class referred to Directive 93/42/ЕЕС).
          • 11.Certificates ISO 9001; ISO 13485. Other standard compliance certificates (if there is a).
          • 12.Copies of the regulations, information on standards and regulatory framework, based on which medical devices are manufactured.
          • Materials regarding the definition of the safety class of medical devices depending on the degree of potential risk.
          • 13.Protocols of the pre-clinical and clinical studies, other studies and scientific information. Literature (articles) on medical use of the device. Recommendation letters from doctors regarding use of medical device. Any other evidences of safety and efficiency use of medical device in other countries (if there is a).
          • 14. If sterility is applied - certificate of sterility, description and validation of sterilization method.
          • 15.Conclusion on the results of metrological certification (for measuring instruments).
          • 16. Labeling information according to international standard EN 980.
          • 17.Copies of all sides of the pack or original packaging in unfolded state (with translation).
          • 18.Certificate of state registration of Applicant’s legal entity (certified by a notary).
          • 19.The document that confirms the authority of the applicant for state registration in the name of the manufacturer (Power of Attorney).
            • Documents listed under paragraphs 7, 9, 10, 11, 13 and 20 should be notarised in the country of origin (for some countries apostil can be required or documents should be legalised in the Consulate of the Ukraine).

              Documents listed under paragraph 3 should be provided on electronic media (CD).

              All documents should be submitted in 4 copies in the original language and include a translation into Ukrainian certified by a translation company (1 set - original or a copy certified by the Manufacturer's corporate seal, and 3 sets - photocopies of all documents certified by the Applicant's corporate seal).

              Don’t you agree that It will be pretty difficult to prepare such package of documents for a person with no experience?

              We are ready to help you with the registration! We will prepare the application and the accompanying documents, will submit the dossier to the civil service and arrange all of the necessary examinations, complete dossier for the Commission (which examines them and decides to give you a certificate or not) and get a certificate of registration for you.

              Also when you make dossier we will provide document templates that describe how and in what form to make out documents, will translate documents from any language, and if necessary, will contact the manufacturer directly.

              Term of receiving of the certificate depends on the specific of production. It should be understood that the deadline for submission of registration dossiers can significantly exceed the term of the registration itself.

              The rate of registration depends on many factors such as: the willingness of manufacturers to provide the required documents, the speed of their legalization, the speed of parcel delivery services, the number and complexity of materials in a foreign language that must be translated, and finally, it depends of how operatively we will work together.

              The cost of registration depends crucially on a lot of factors, such as: the type of products, their safety class and finally of the range of products.

              For example, the cost of registration of eyeglass frames or bandages is several times lower than the cost of registration of implants, or any other electrical devices.

              If you want to know a price of registration - submit us a description of products and range you want to register, and we will form registration budget for you.

              To receive the consultation you can contact us by phone or by email named below or you can come and meet us in our office.

Responsible specialists
Anna Kabanets
Lawyer of the Departmentof registration of fertilizers, medical devices, licensing and bar coding
+38 093 015-75-42
cav@viconsult.com.ua
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Anna Kabanets
Hanna Chemodurova
Legal assistant of the Departmentof registration of fertilizers, medical devices, licensing and bar coding
+38 093 723-69-84
cgv@viconsult.com.ua
live:.cid.16aeeb57a0c67e82
Hanna Chemodurova