Certification and declaration

A conformity certificate and a conformity declaration are two forms of mandatory product certification for compliance with the requirements of national standards or other regulatory documents.

The documents are required for customs clearance and sale of medical products in the territory of the Russian Federation.

Compulsoriness of a conformity declaration and a conformity certificate is determined for specific types of goods based on the Government Decree No. 982 dated December 1, 2009. The decree is called “On the approval of a single list of products subject to mandatory certification, and a single list of products, whose conformity verification is performed in the form of conformity declaration adoption”. The document is up-to-date with amendments as of February 21, 2018 in the wording effective from December 27, 2018.

The presence of a product in a particular section determines the need for a particular document.

Some differences between a certificate and a declaration: Only a Russian taxpayer can draw up a product conformity declaration in the Russian Federation. At the same time, a foreign manufacturer can also receive a conformity certificate for its products in Russia.

In the case a certificate is obtained, the manufacturer shares the responsibility for the information included in the document, for products safety, with the certification body where the conformity assessment document was drawn up.

While, when receiving a conformity declaration, all responsibility remains with the products manufacturer (or another person performing the declaration).

In the case a conformity certificate is obtained, the document is drawn up on a typographic form. Products conformity declaration of is filled out on a standard sheet of paper.

In case a medical product is absent in both lists, this indicates that it is not subject to mandatory declaration or mandatory certification.

In this case, for customs clearance, it is better to issue a letter of exemption from mandatory certifying from the certification body, which will contain information that it is not required to perform declaration and certification.

For advertising or other similar purposes, one can draw up a voluntary conformity certificate.

Upon your request, we will be delighted to draw up any of the documents listed above, arranging product testing for these purposes if necessary.