On February 5, 2015 the Government Decision No. 102 "On the establishment of limitations on admission of certain types of medical devices originating from foreign States for the purposes of procurement for state and municipal needs" entered into force .
According to the text applications for medical devices supply of all foreign countries, except Armenia, Belarus and Kazakhstan, will be rejected if at least two bids are submitted from Russian, Armenian, Belarusian and Kazakh manufacturers. List of medical products in respect of which restrictions are imposed, covering the range of medical clothing to the x-ray diagnostic complexes, is attached to the Decision.
The Decision opens the Russian manufacturers and foreign companies, basing their production in Russia, new opportunities for sales. In order to convert potential benefits into investments and profit, the manufacturer needs to meet a number of conditions put forward by the government. In practice, this primarily means getting ST-1 certificate.
We are ready to support domestic companies and foreign localized producers in obtaining:
In accordance with the draft "Procedure for filling acts of examination to determine product origin country..." the annual acts of the examination for registration certificate form ST-1 are drawn up by the authorized CCI for a period of one year. For obtaining the annual act, following documents should be provided:
2. Title and registration documents of the applicant.
3. Documents and information confirming the existence of production.
4. Information and documents confirming the fact of manufacture of the product.
5. For goods manufactured with use of foreign goods, additional documents are provided.
In accordance with the draft "Regulations on the procedure for issue of certificates of origin form ST-1 for the purposes of procurement for state and municipal needs (for certain types of medical devices)" procurement participant when handling authorized CCI with the application for grant of ST-1certificate should provide the following information and documents:
1. Legal and constituent documents of the applicant.
2. In the presence of annual examination act the applicant indicates in the statement information about the annual examination act (number, date, name of issuing authorized CCI). In the absence of annual examination act, the applicant must submit to the authorized CCI the following information and documents confirming:
3. For goods manufactured with use of foreign goods, additional documents are provided.
4. If the applicant is not the manufacturer and/or owner of the goods (object of the purchase), he additionally submits to the authorized CCI a guarantee letter on the contract with the manufacturer or other person for the supply of goods (object of the purchase) in the required quantity and nomenclature in case such applicant is identified as the supplier of goods for procurement.