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 or major design modification) require a full amendment submission. Minor changes (such as updated contact details) may be notifiable but follow a simpler process. Consult your RUS REP to determine the applicable route for specific changes.
Registration expiry and re-registration
Registration Certificates have a defined validity period. Re-registration must be initiated before expiry. Given the 2027 deadline for national registrations, manufacturers should assess whether re-registration under EAEU rules is more appropriate when a national certificate approaches expiry.
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.
Government Decree No. 1684 (2025): government.ru