Ukraine Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-24-2011, 23:45 PM

General Market Condition: No Restrictions
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.
There is no special procedure for registration of used/refurbished medical equipment. There are no special restrictions or tariffs that apply to used medical equipment.
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.
If a manufacturer or its agent has registered a medical device in the country, a third party can legally import the same device in used/refurbished condition without the used device being subject to new safety inspections and registration.
Public health institutions can buy used/refurbished medical devices if these devices are registered in Ukraine.
Receptivity for used dental equipment is average; as the price difference between local and imported used equipment has narrowed, the motivation to purchase used equipment has also decreased. However, a potential market for used dental equipment exists, the preferred approach being the creation of a refurbishing joint venture with local partner.
Registration Form Requirements
A. General information

Name of the medical use product -synonyms, trade mark (in original language, in English, and in Ukrainian).
Applicant (country where the applicant is registered, address, phone, fax, e-mail, national registration number and code).
Manufacturer (country where the manufacturer is registered, address, phone, fax, e-mail, national registration number).
Document confirming the authority of an applicant to represent a manufacturer (if an applicant is not a manufacturer - a contract, or power of attorney).
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 US and a certificate of acceptance of a foreign certificate may not be issued without the actual testing of the product.)
Are there special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment?
There are no special restrictions or tariffs that apply to used medical equipment in Ukraine.
Can public health institutions buy used or refurbished Medical devices?
Public health institutions can buy used and refurbished medical equipment.
Is there a market for used of refurbished devices?
The market for used medical equipment is small in Ukraine—importers prefer to buy new equipment, although new equipment is more expensive.
If there is a market, what types of used or refurbished medical equipment are in the greatest demand?
The demand for used equipment is to be identified on case-by-case basis.

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