Amendment of Registration Certificate

Home Registration in Russia

Types of amendments to be made:

  • Changes in information about applicant
  • Changes in information about certificate holder
  • Change of the address of the production site
  • Change of product type according to product classification
  • Changes in the name of the medical product/device
  • Changes in the OKP code (Russian Classification of medical products)

Amendments to the Registration Certificate

  • Changes in normative documents or national (international) standards that regulate the production and operation of the medical product
  • Changes in labelling or packaging of the medical product
  • Changes in shelf-life, expiry date and warranty period as well as changes with regard to information on servicing, repair and disposal of the medical product
  • Changes in the scope of application of the medical product
  • Changes of individual characteristics of the medical product (provided that functionality of the medical product/device remains unchanged)

Receipt of a duplicate copy of a registration certificate

Should the registration certificate be lost or damaged the applicant is entitled to apply to Roszdravnadzor with the request of the duplicate copy of the registration certificate (hereinafter referred to as the duplicate copy request).

Should the registration certificate be damaged the duplicate copy request shall have the damaged registration certificate attached.

Replacement of the registration certificate form

All registration certificates with unlimited validity issued before 01.01.2013 are subject to mandatory replacement by 01.01.2021 pursuant to Regulation No. 160 dated 10.02.2017 on amendments to Regulation of Government of the Russian Federation No. 1416 dated 27.12.2012.