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Registration Maintenance

Keeping the Registration Certificate current​

The GRLS entry and Registration Certificate must reflect the current state of the device at all times. Manufacturers must notify Roszdravnadzor of any changes that affect:

  • Device design, materials, or intended purpose
  • Manufacturing site or processes
  • Labelling, labelling language, or IFU
  • Authorized Representative details
  • Manufacturer name or address

Changes that affect safety or performance may require a formal amendment application and potentially new expert review.

Significant vs minor changes​

Not all changes carry the same notification requirement. Under Decree No. 1684, significant changes (such as a new intended purpose, major design modification, or manufacturing process change) require a full amendment submission with expert review. Minor changes (such as updated contact details or non-material updates to labelling) may follow a simplified notification process. Consult your RUS REP to determine the applicable route for specific changes, as misclassification can delay registration updates.

Registration expiry and re-registration​

Registration Certificates have a defined validity period. Re-registration must be initiated before expiry. New national submissions may be accepted until 31 December 2027 (extended via EAEU Protocol signed 29 December 2025), and national registration/re-registration completion under Union rules is permitted until 31 December 2028; manufacturers should assess whether re-registration under EAEU rules is more appropriate when a national certificate approaches expiry. Source: EAEU Eurasian Economic Commission (eec.eaeunion.org).

Suspension and cancellation​

Roszdravnadzor can suspend or cancel a Registration Certificate if:

  • The manufacturer fails to comply with post-market obligations
  • Safety issues are identified that are not adequately addressed
  • Required annual clinical monitoring reports are not submitted
  • The manufacturer or RUS REP ceases to exist without a replacement being appointed

A suspended or cancelled device cannot be legally distributed in Russia.

Official source

Government Decree No. 1684 (2025): government.ru