Call us, we're always on the phone
+7 (708) 500 10 56
Call us, we're always on the phone
+7 (708) 500 10 56
We will develop documentation for a product of any complexity.
Revision of instructions, passport, ST.
Selection of laboratories for the full package of tests
We go through the whole process together, and we'll finalize everything that needs to be finalized.
We do everything on a turnkey basis — from the first email to registration
The personal manager is always in touch
Specific steps, not general promises
We are working with the Single Window system, preparing a set of documents, helping you to pass an expert examination and protect your product before the regulator.
The characteristics, the principle of operation, and the purpose will be drawn up strictly according to the requirements of the expert body.
We will develop the ST of the LLP, prepare production regulations and control methods.
We will select an accredited laboratory in the Republic of Kazakhstan or abroad, prepare samples and conduct tests without bureaucracy.
We will accompany you until you receive the order for the product.
Everything that the doctor sees and the Ministry of Health checks: instructions, passport, label — we bring in line, working together with your designer.
Risk management (ISO 14971), evidence of effectiveness, summary report.
Primary diagnostics — we study the product, documents, goals
We sign a contract and a schedule of work
We accompany you in obtaining a pharmaceutical license
We help to prepare the room so that it is suitable for obtaining ISO 13485
We are developing the entire set of documents
We accompany laboratory tests
We form the dossier structure based on the requirements of the Republic of Kazakhstan
We are preparing for submission and passing the NCELS inspection as part of the examination.
We will accompany you until you receive your Registration Certificate.
We are sending you the final documents with explanations and recommendations.
Starting from 2025, for registration of medical devices of any risk classes in Kazakhstan
a mandatory stage is the inspection of production.
The inspection confirms that your
quality system requirements of ISO 13485.
Not sure if your product needs to be registered?
We will advise you based on our experience for free or we will accompany the membership procedure in an expert body.
All regulatory, technical and consumer documentation is designed taking into account your product type, production base and real conditions.
We accompany you not only at the preparation stage, but also at the examination stage.
You get an account with which you can legally bring the product to the market.
We don't just do it for you. We explain, we teach, we involve. So that your team knows how to proceed with future checks and re-registration.
You will not be left alone with the documents.
We'll show you where everything is, and how to use it
and what to pay attention to.
We submit the documents so that the regulator does not have to "reject" them or return them for revision.
You see what you are paying for, what steps are included
to work, and at what stage you are. All obligations are spelled out — without the "fine print".
If your product is used for diagnosis, treatment, prevention, or
monitoring of a person's condition — most likely, it is subject to registration
as a medical device. We will conduct an initial assessment for free and give
the exact answer.
Yes. We will help you get a pharmaceutical license — it's a must
the stage for submitting documents on behalf of the manufacturer or the applicant.
No, if you have risk class 1 and 2a, non-sterile products. However, because
inspection is now provided for all classes, you may not receive
ISO, but must ensure compliance with the documentation and the site of its
requirements. This means that obtaining the certificate itself is not necessary,
but documentation development is mandatory.
We make all adjustments at our own expense. It's written in the contract — you
protected from additional costs.
Yes. We are doing an audit of already submitted dossiers, correcting errors and preparing a package
to register again the first time.
The cost depends on the complexity of the product, the risk class and the volume
documentation. We make the calculation after the free diagnosis and record
the amount in the contract. No “unexpected surcharges".
We are preparing a dossier for both procedures at once — the national (ROK) and the EAEU.
We will help you with registration and appointment of an authorized representative.
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