Kazakhstan Accelerated Medical Device Registration: The 15 Working Days Pathway

1. Key takeaways

Under the 2026 one-window combined service pilot, medical devices from jurisdictions with a good regulatory reputation (the US, the EU, the UK, Japan and others) may use an accelerated procedure completed in as few as 15 working days. This is not an unconditional fast lane: eligibility depends on two elements, the place of manufacture of the product and its marketing approval status in the country of origin. Products from other jurisdictions follow the conventional procedure, with a combined service total of no more than 100 working days. For Chinese manufacturers, the decisive question is not whether a CE certificate or FDA approval exists somewhere in the portfolio, but whether the manufacturing site is located in one of the listed jurisdictions and the product has been approved for circulation by the local regulatory authority. Read together with the laboratory-study exemptions, which apply the same jurisdiction logic, the pilot rewards manufacturers whose production footprint already overlaps with mature regulatory markets. The two eligibility elements should therefore be verified for every product in the portfolio separately, because a single certificate or a single site rarely covers a whole product family.

2. Legal basis

3. Expert insights

Insight one: the eligibility elements are place of manufacture plus approval status, not certificate type. Order No. ҚР ДСМ-10 already contains nearly the same logic: medical devices manufactured at sites in the EU, the UK, the US, Canada, Japan or Switzerland, and approved for circulation by the regulatory authorities of those countries, are exempt from laboratory studies. The accelerated procedure follows the same jurisdiction test and extends the benefit from an exemption from laboratory studies to a full-process acceleration. The consistency between the two provisions matters in practice, because a product that qualifies for the laboratory exemption is very likely to qualify for the accelerated lane as well, and the same body of evidence supports both assessments. Companies can use one eligibility memo to serve both, provided it cites the specific provisions of each regime.

Insight two: 15 working days is the minimum value, not the typical value. The accelerated procedure’s shortest duration is 15 working days, but the actual cycle remains subject to the completeness of the dossier, whether remedies are required, and whether an inspection is needed. Reading the figure as a limit value rather than an expected value prevents systematic misjudgment of project timelines. GRZAN advises internal stakeholders to see the accelerated lane as a best case that may be achieved only with a complete, remedy-free dossier, and to build every external commitment on a more conservative estimate. A short internal note explaining the distinction between the limit value and the expected value prevents the accelerated figure from entering sales commitments.

Insight three: for most Chinese manufacturers, the accelerated lane is not a directly available path. Products manufactured in China usually do not satisfy the jurisdiction element, regardless of whether the design or the approvals originate elsewhere. This does not mean there is no room for speed: the combined service total of 100 working days under joint order No. 30 / No. 140 is already a marked compression against the conventional procedure of 110 or 70 working days plus an inspection. The realistic strategy for such manufacturers is to secure the combined-service figures and to eliminate remedy rounds rather than to chase the accelerated lane.

Insight four: the place-of-manufacture element can be changed through capacity planning. Companies that operate approved manufacturing sites in the EU, Japan or other listed jurisdictions can allocate the relevant products to those sites and thereby acquire eligibility for the accelerated lane. This is a cross-decision between capacity planning and registration strategy, and it belongs in the investment stage: retrofitting a production footprint after a launch date has been promised is far more expensive than choosing the site with the regulatory benefit in view from the start. Even where relocation of production is not feasible, partial qualification of some models can still deliver meaningful acceleration at the portfolio level.

4. Practical recommendations

1. Verify the two elements first: the jurisdiction of the manufacturing site and the product’s marketing approval status in its country of origin.
2. Treat 15 working days as a limit value rather than an expected value, and model internal schedules on a more conservative estimate.
3. If the accelerated elements are not met, still pursue the combined service total of 100 working days.
4. Companies with overseas capacity should factor accelerated-lane eligibility into site selection decisions.
5. Evaluate accelerated-lane eligibility and the laboratory-study exemption together, since both share the same jurisdiction logic.

5. Verification checklist

• □ The jurisdiction of the manufacturing site has been verified (US / EU / UK / Japan and others)
• □ The marketing approval documents for the product in its country of origin are complete and valid
• □ Internal schedules are modeled on a limit value plus remedy buffer, not directly on 15 working days
• □ Where accelerated elements are not met, applicability of the 100 working days combined service has been confirmed
• □ Eligibility for the laboratory-study exemption has been assessed in parallel
• □ The eligibility conclusion is documented in writing with supporting evidence of both elements

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering accelerated-lane assessment, dossier preparation, expert review follow-up and post-grant registration maintenance. For assistance with this topic, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.