Axis Reg

Q: Can we use a dossier that is only in English?

Yes. Our staff includes certified medical translators. If you have documentation only in English, we will prepare a professional translation into Russian and Kazakh in accordance with the regulator's requirements.

Q: Does a company representative need to travel to Kazakhstan?

No. The entire process is handled completely remotely. We act on your behalf on the basis of a notarized power of attorney, saving you from flights and bureaucracy.

Why do you lose 6+ months
before your first sale?

01.

Incorrectly assembled dossier

Ministry of Health rejections and frozen investments over a single comma or incorrect translation.

02.

Hidden Fees

Marked-up state duties and surprise surcharges that appear mid-registration.

03.

"Black Box"

Zero communication from your contractor. Hundreds of thousands lost on idle inventory.

We solve these problems systematically.

See our competencies →

Core Competencies

Registration Dossier Preparation

Professional preparation and audit of documents in strict accordance with state requirements.

Expertise Support

Direct interaction with expert organizations and rapid resolution of any inquiries during the registration process.

Technical File

Medical translation, adaptation of instructions, and risk management files strictly according to nomenclature.

Cosmetics & Disinfectants

Full cycle registration of cosmetic products and disinfectants in health authorities.

Architecture of the process

Stage 1

Dossier Adaptation

Dossier compilation, medical translation, and technical file formation.

Stage 2

Submission & Expertise

Official submission of the dossier, passing primary and specialized expertise.

Stage 3

Laboratory Testing

Analytical stage and obtaining a conclusion on the safety and quality of the device.

Final

RC / SRC Issuance

Official receipt of the Registration Certificate (RC) or State Registration Certificate (SRC).

Portfolio

Registered products

Companies and products registered with our end-to-end support.

Medical devices

Johnson & Johnson

contact lenses suture materials catheters absorbable sutures absorbable sponge

Registration support for contact lenses, suture materials, catheters, absorbable sutures, and absorbable sponges.

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Fig. 1.1 — Johnson & Johnson products

Medical devices

Abbott Medical

catheters electrophysiology cables

Registered catheters and electrophysiology cables for cardiac surgery and interventional procedures.

Request a similar project

Fig. 1.2 — Abbott Medical products

Medical devices

Stryker

vertebroplasty kit surgical instruments

Registered vertebroplasty kits and surgical instruments for orthopedics and neurosurgery.

Request a similar project

Fig. 1.3 — Stryker products

Medical devices

Rospotrebnadzor

reagent kits

Registered reagent kits for laboratory diagnostics and quality control.

Request a similar project

Fig. 1.4 — Rospotrebnadzor products

Medical devices

Dentsply

dental materials dental instruments

Supported registration of dental materials and instruments for clinical and orthodontic use.

Request a similar project

Fig. 1.5 — Dentsply products

Disinfection

Raster

disinfectant

Registered a disinfectant for surface treatment in healthcare facilities.

Request a similar project

Fig. 1.6 — Raster products

Supplements & cosmetics

Orhun Pharma

cosmetics dietary supplements

Registered a line of cosmetic products and dietary supplements for the retail market.

Request a similar project

Orhun Pharma cosmetics and dietary supplements

Fig. 1.7 — Orhun Pharma products

Johnson & Johnson

Medical devices

Fig. 1.1 — Johnson & Johnson config

Medical devices

contact lenses suture materials catheters absorbable sutures absorbable sponge

Registration support for contact lenses, suture materials, catheters, absorbable sutures, and absorbable sponges.

Request a similar project

Abbott Medical

Medical devices

Fig. 1.2 — Abbott Medical config

Medical devices

catheters electrophysiology cables

Registered catheters and electrophysiology cables for cardiac surgery and interventional procedures.

Request a similar project

Stryker

Medical devices

Fig. 1.3 — Stryker config

Medical devices

vertebroplasty kit surgical instruments

Registered vertebroplasty kits and surgical instruments for orthopedics and neurosurgery.

Request a similar project

Rospotrebnadzor

Medical devices

Fig. 1.4 — Rospotrebnadzor config

Medical devices

reagent kits

Registered reagent kits for laboratory diagnostics and quality control.

Request a similar project

Dentsply

Medical devices

Fig. 1.5 — Dentsply config

Medical devices

dental materials dental instruments

Supported registration of dental materials and instruments for clinical and orthodontic use.

Request a similar project

Raster

Disinfection

Fig. 1.6 — Raster config

Disinfection

disinfectant

Registered a disinfectant for surface treatment in healthcare facilities.

Request a similar project

Orhun Pharma

Supplements & cosmetics

Fig. 1.7 — Orhun Pharma config

Supplements & cosmetics

cosmetics dietary supplements

Registered a line of cosmetic products and dietary supplements for the retail market.

Request a similar project

Intellectual
Capital

Your project will be handled by specialists with 10+ years of domain experience. We do not hire interns for million-dollar contracts.

Former auditors of state bodies

Certified medical translators

International regulatory consultants

Transparent pricing

Under EU/EAEU rules, devices are grouped into risk classes: higher classes mean a fuller dossier and stricter review. We support registration across all classes, including Class IIb and Class III — implantable and other high-risk devices. Scope and fee estimates are agreed before work begins — no hidden charges.

Basic Consulting

For those with an existing dossier (incl. Class 1, 2a)

Individual calculation

Request a Quote

Premium

Turnkey Service

Incl. complex translations and Classes 2b, 3

Individual calculation

Request a Quote

Calculate the cost
in 1 minute

Step 1 of 3 33%

Step 1: What are we registering?

Step 2: Country of manufacture?

Step 3: Do you have an existing dossier?

Excellent!

Leave your contacts — we’ll email a personal PDF estimate and follow up on WhatsApp within 15 minutes.

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Estimate arrives instantly. Manager follows up on WhatsApp.

Frequently Asked Questions

What happens if the Ministry of Health rejects the registration? +

We reduce the risk to <1% through deep internal QA audits. If a rejection occurs due to our fault, we provide a free re-submission — this is strictly stipulated in the contract.

Can we use a dossier that is only in English? +

Yes. Our staff includes certified medical translators. If you have documentation only in English, we will prepare a professional translation into Russian and Kazakh in accordance with the regulator's requirements.

Does a company representative need to travel to Kazakhstan? +

No. The entire process is handled completely remotely. We act on your behalf on the basis of a notarized power of attorney, saving you from flights and bureaucracy.

Legal market entry into Kazakhstan (EAEU) without risks.

80% of agencies
miss their deadlines.