Updated: 04/20/01.

Regulatory Agency

The act of registering or re-registering medical use products in Ukraine is performed by the State Department of Quality Control, Safety and Manufacture of Medicinal and Medical Use Products.

Registration Procedures

Procedures for registering medical equipment and medical use products were approved by the Ministry of Health of Ukraine on September 26, 2000. The procedure was filed by the Ministry of Justice of Ukraine on January 17, 2001, and is now law.

Registration is a requirement for the importation of medical products into Ukraine. Applications for registration must be submitted (on a standard form) to the State Department on Control of Quality, Safety and Manufacture of Medicinal and Medical Use Products (see below).

In addition, the following must also be provided with the application: catalogues of the product, manuals, technical specifications, certificates (manufacturer's certificate, certificate of origin), foreign certificates (if available), a certificate of conformance issued by a Ukrainian certifying agency (if available), information on manufacturing standards (if available), trade mark samples, and manufacturer's registration documents.

Registration is performed by the State Department on Control of Quality, Safety and Manufacture of Medicinal and Medical Use Products, and is based on evaluation of the product by expert testing agencies. Once registered, a product is included in the State register of medical equipment and medical use products.

Registration is valid for five years. The procedure for renewal of registration is the same as described above.

Registration form requirements:

Application No. ___________
for state registration of a medical use product
Date
A. General information
a). Name of the medical use product -synonyms, trade mark (in original language, in English, and in Ukrainian).
b). Applicant (country where the applicant is registered, address, phone, fax, e-mail, national registration number and code).
c). Manufacturer (country where the manufacturer is registered, address, phone, fax, e-mail, national registration number).
d). Document confirming the authority of an applicant to represent a manufacturer (if an applicant is not a manufacturer - a contract, or power of attorney).
e). Ukrainian customs code for the medical use product.
B. A certificate of conformance issued by a Ukrainian certifying agency.

I certify that the applying product complies with quality and safety requirements, as stated in the supporting documentation, and with requirements of Ukrainian legislation as to quality and safety for human health and the environment.

Date Signature of applicant

The documents that confirm the compliance of goods with Ukrainian certification requirements are:

- a certificate of conformance issued by a Ukrainian certifying agency, upon certification of goods; or

- a certificate of acceptance of a foreign certificate issued by a Ukrainian certifying agency, upon acceptance of a foreign certificate.

Note: Certificates issued by foreign authorities are recognized in Ukraine only to the extent provided in international treaties to which Ukraine is a party. No intergovernmental agreements on goods certification exist between Ukraine and the U.S. and a certificate of acceptance of a foreign certificate may not be issued without the actual testing of the product.)

Contacts at the State Department on Control of Quality, Safety and Manufacture of Medicinal and Medical Use Products, Division for Registration and Certification of Medical Equipment and Medical Use Products:
Yaroslav Penishkevich, Head of the Division
50 Popudrenko St., Kiev 253660, Ukraine
Tel: (380-44) 559-5033, fax: (380-44) 513-7214
e-mail: yary@cmt.kiev.ua

For additional information on the medical industry sector in Ukraine, please contact your nearest USDOC Export Assistance Center, with a copy to: David Hunter, CS Kiev Senior Commercial Officer; and Olena Stephanska, CS Kiev Commercial Specialist,
E-mail: Olena.Stephanska@mail.doc.gov
The Commercial Service, U.S. Embassy Kiev,
7, Kudriavsky Uzviz, Kiev 254053, Ukraine,
Tel: (380-44) 417-1413, 417-2669;
Fax: (380-44) 417-1419.