Kazakhstan Medical Device Portfolio Planning After 2028: Managing National and Union Certificates

1. Key takeaways

After January 1, 2028, new registrations in Kazakhstan proceed only under Union rules, but national registration certificates obtained before that date remain valid. Certificates of medical devices registered under national rules have no validity period limit and can continue to circulate in Kazakhstan. The typical shape of a portfolio after 2028 is therefore parallel coexistence: existing products hold national certificates that remain valid indefinitely, while new products enter through the Union pathway. Managing this combination turns on evidence package reuse and on running the two sets of compliance obligations on separate tracks, with a unified ledger as the control instrument. Companies that plan for this shape early avoid the cost of hurried conversions later, when the national pathway has already closed to new entrants.

2. Legal basis

3. Expert insights

Insight 1: parallel coexistence is not a transitional state but a long-term shape. National certificates have no expiry date, while the Union certificate is the only entrance for the future; the two will coexist in the same product portfolio for many years. What a company needs is not a switch plan but a parallel management scheme, with governance, records and responsibilities designed for two regimes running at the same time rather than for a single regime that will one day replace the other. Budgeting should likewise assume two permanent compliance workstreams, not a temporary overlap that will resolve itself.

Insight 2: running post-market obligations on separate tracks is the greatest complexity of parallel management. National certificates are subject to Order No. ҚР ДСМ-320/2020, Union certificates to Decision No. 174; change procedures are likewise separated, with national certificates following national rules and Union certificates going through recognition by the reference member state. The representative must master both sets of rules, and the surveillance ledger must be capable of being listed by pathway so that every product is always evaluated under the rules that actually apply to it. Agreement templates should also state explicitly which regime governs each obligation, so no duty falls between the two sets of rules.

Insight 3: evidence package reuse is the key to reducing cost. The general safety and effectiveness requirements of Decision No. 27 overlap heavily between the two pathways. Technical documentation, risk management files and clinical evidence can share the same base materials, with only the argumentation structure separated by pathway. When preparing for the Union pathway, companies should use the national pathway dossier as the starting point rather than building from zero, which cuts both preparation time and the risk of inconsistency between the two files. Differences in argumentation structure should be documented once, in a mapping note, rather than re-derived each time a new product enters the Union pathway.

Insight 4: December 31, 2028 is the last date for doing things under national rules. Until then, changes and dossier organization can be handled under national rules, which is usually the simpler route. Where existing products have major changes planned, those changes should be moved forward as far as possible, because after the window closes the same change must run through the Union procedure with its additional formalities and reference-state review. Planning the change calendar in 2026 and 2027, rather than late in 2028, leaves room for the review cycles that each change will need.

Insight 5: parallel management requires a single unified register ledger. One product portfolio can contain national certificates and Union certificates, different representatives under different pathways, different change statuses and different inspection cycles. Without a unified ledger, management loses control quickly: obligations are tracked under the wrong rules, renewals of appointments lapse silently, and the first sign of trouble is a regulator question rather than an internal alert. A quarterly review of the ledger against the actual certificates and appointments is the minimum control that keeps the picture accurate.

4. Practical recommendations

1. Build a pathway ledger that records, product by product: pathway, certificate number, representative, change status, inspection cycle and applicable surveillance rules.
2. Organize evidence packages on the principle of shared base materials and separated argumentation structures, with the Union pathway starting from the national dossier.
3. Ensure the representative’s capability covers both sets of rules: Order No. ҚР ДСМ-320/2020 and Decision No. 174.
4. Schedule major changes of existing products before December 31, 2028 wherever possible.
5. Prepare evidence packages for new products to the depth required by Union rules, to avoid redoing base work after 2028.

5. Verification checklist

• □ A pathway ledger has been built (pathway, certificate number, representative, change status, inspection cycle, surveillance rules)
• □ The evidence package structure of shared base materials with separated argumentation has been established
• □ The representative is capable of executing both sets of rules
• □ Major changes of existing products have been scheduled before December 31, 2028
• □ Evidence packages for new products have been prepared to the depth of Union rules
• □ The two surveillance ledgers can be retrieved separately and cross-indexed

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Kazakhstan, including dual-pathway portfolio management and Union pathway preparation. For inquiries, contact info@grzanglobal.com.