The registration procedure given below describes general requirements for preparation and conduct of registration for use of medical equipment and Goods for medical purposes in the Republic of Uzbekistan (hereinafter called “the Goods”) to be procured under Health-2 Project 3979 UZ.
Registration of Goods is carried out by the following duly authorized organization:
Head Department of Drug and Medical Equipment Quality Control within the Ministry of Health of the Republic of Uzbekistan (hereinafter called “the Head Department”)
16, proezd K. Umarova, Usmankhodjaev str., 700002, Tashkent, Republic of Uzbekistan
Tel: ( 998 71 ) 244 48 23, ( 998 71) 249 48 27
Fax: ( 998 71 ) 244 48 25
The Applicant for registration of Goods is a successful Bidder with whom the contract for the supply of Goods has been entered into and who has authorization from the Goods’ Manufacturer.
For the Goods subject to registration in the Republic of Uzbekistan, the Supplier shall submit the following materials to the Head Department within three (3) weeks from the receipt time of the Notification of Contract Award, and copy to the Purchaser, unless the Goods have already been registered in the Republic of Uzbekistan and the registration certificate remains valid at the time of the goods delivery to Uzbekistan:
1. Request for registration (Section VIII clause 7);
2. Application form (Section VIII clause 8);
3. Summary of product;
4. Certificate of origin and certificate of quality;
5. Registration certificate or equivalent document confirming registration of medical equipment and products for medical purposes in the country of origin as well as in any other countries where the considered goods have been registered;
6. Registration documents of products for medical purposes as measuring device in the country of origin and/or other countries (if any);
7. Manuals on operation and passport of product;
8. Information (acts and protocols) about technical and clinical examinations and laboratory researches;
9. Analysis certificate of end products to presented series of medical product;
10. Standard-technical documentation, including methods and orders of examination of products for medical purposes. Testing methods of medical equipment (for measuring devices). Information about Compliance to International Standards and standard (if required) of given type of product;
11. Samples of packing and document, regulating the quality of packing materials;
12. Information about operation (exploitation) warranty;
13. Use (application) information of products in medicine (on main literature publications);
14. Prospects, catalogues, data sheets;
15. Copy of Contract;
16. Samples of medical equipment and products for medical equipment, required for registration (all the samples must be of the same series), in quantity stated in Section VI. Schedule of Requirements;
17. Manufacturer’s Letter of Attorney given to an authorised individual to carry out registration. Letter of Attorney must be formed and notarized according to set orders.
The documents stated under items 4, 5, 6, 8, 9 shall be submitted in original, or in copy notarized in appropriate order.
The documents, stated under items 7, 8, 9, 10 shall be submitted in original and translated into Russian (or Uzbek) language.
Originals and copies of documents shall be accurate, easy readable, include signs and seals/stamps, without amendments and corrections.
All above mentioned documents (submission of originals and notarized copies is necessary), in duplicate, and samples of products for medical purposes in quantity required for examinations, shall be submitted directly to Head Department of Drug and Medical Equipment Quality Control.
Registration process and terms are determined by the Head Department taking into account the peculiarities of testing and use of the Goods in the Republic of Uzbekistan and shall be performed within sixty (60) calendar days from the date of receipt by the Head Department of all documents and samples specified above.
Process of registration begins upon receipt of bank notification about payment for full cost of works, and upon receipt of all documents and samples specified above.