Kazakhstan Medical Device Registration: Amendment Procedures, Re-registration and Timeline

1. Key takeaways

Maintenance of a registration dossier in Kazakhstan involves three actions: dossier amendment, meaning modification of an already registered dossier; re-registration, which applies in specific cases such as devices manufactured in Kazakhstan under national rules, with a duty of 5 MRP, equal to 21,625 tenge; and register maintenance, ensuring that register records match the physical product and the dossier. The procedures differ, and rejections concentrate in two categories: incomplete materials and misjudgment of the type of change. Both categories are controllable with disciplined internal review, which is why the process description below matters as much as the deadlines themselves. Under the protocol signed on December 29, 2025, the window for submitting amendment and dossier housekeeping applications under national rules closes on December 31, 2028. The practical estimate is that every change project started late in the window competes for authority capacity with all other late filers, so early scheduling is itself a risk control.

2. Legal basis

3. Expert insights

Insight one: the test for choosing among the three actions is what exactly is being changed. Changing the manufacturing site, the authorized representative, the models and specifications or the label text goes through a dossier amendment; re-registration of devices manufactured under national rules in specific cases goes through re-registration; keeping records consistent with physical products is register maintenance. A wrong judgment leads to rejection, and the time cost of rejection is especially expensive inside the closing window. As a working rule, the change type should be documented in the project file with the legal basis cited, so that if the authority questions the classification the answer is already on record rather than reconstructed under deadline pressure.

Insight two: the one-window integrated service introduced in 2026 brings amendments into a single entry point. The integrated service under joint orders No. 30 and No. 140 covers five items: expert examination, registration and re-registration, changes to registration dossiers, registration and adjustment of manufacturer prices, and formation of the national medicines list. Amendments can be submitted through the same digital entry point, but the overall time limit of the integrated service is 100 working days, excluding time for deficiency corrections and inspections. Companies using the service should therefore build two separate clocks into the project plan: the statutory clock for the service itself and a contingency clock for the excluded stages.

Insight three: Order No. 146 expanded the circumstances for register entries. When Order No. 146, signed November 18, 2025, amended Order No. ҚР ДСМ-16, it clarified that information is entered into the national register not only at registration or re-registration but also in cases such as extension of the validity of the registration certificate. The accuracy of the register therefore has a clearer institutional requirement. In practical terms this means register data should be treated as living compliance records, with an owner inside the manufacturer organization and a defined update trigger for every certificate event.

Insight four: amendment materials prepared as a simplified first registration achieve the highest acceptance rate. A new manufacturing site requires QMS evidence for that site, a new model requires technical documentation and test reports, and a label revision requires bilingual Russian and Kazakh text. Treating an amendment as a simplified version of a first registration, rather than as filling in one form, is the key to fewer rejections. The scope of evidence scales with the scope of the change: a wider change set needs a proportionally wider evidence set, and the two should be mapped before submission.

Insight five: after the window closes, amendments will be handled under Union rules and the cost structure will change. After December 31, 2028, the channel for processing changes under national rules will no longer be available. Major changes to legacy products should be moved forward as far as possible, and this date should be written into the long-term compliance calendar. For products with a long remaining life on the certificate, the choice is between completing major changes under national rules inside the window or preparing for the Union procedures later, and that choice affects budget, evidence and timeline at the same time.

4. Practical recommendations

1. Build a change type decision table: first decide among amendment, re-registration and register maintenance, then prepare materials.
2. Amendments within 2026 may be evaluated for submission through the one-window integrated service, noting that correction and inspection time are counted separately.
3. Prepare amendment materials to the standard of a simplified first registration: QMS evidence for sites, technical documentation and test reports for models, bilingual text for labels.
4. Create an annual register reconciliation plan comparing register records with physical labels model by model.
5. Schedule major changes for completion before December 31, 2028 where possible.

5. Verification checklist

• □ A change type decision table has been built, covering amendment, re-registration and register maintenance
• □ The re-registration duty has been calculated at 5 MRP, equal to 21,625 tenge
• □ Amendment materials have been prepared to the standard of a simplified first registration
• □ An annual register reconciliation plan has been prepared and executed
• □ Major changes have been scheduled before December 31, 2028
• □ Correction and inspection time has been deducted for amendments submitted through the integrated service

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, including amendment filings, re-registration and register reconciliation. Change classification and evidence mapping are performed before submission to reduce rejection risk. For inquiries, contact info@grzanglobal.com.