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Documents that will pass registration
the first time!

No tweaks. No rejections. On time.

    Name*
    Phone*
    Email

    What documents are required
    for registration?

    Application for
    registration

    Technical
    product description

    Clinical and technical
    trials

    Instructions for
    application

    Labeling
    and packaging

    Production documents
    (certificates, licenses)

    You're not sure which ones
    you have the paperwork,
    What's missing?

    Leave a request, we will conduct an audit
    for free!

    Simple and complex medical devices:
    what's the difference?

    Simple products

    (Class 1 and 2a)

    • Low risk to the patient
    • Minimum test requirements
    • Fast registration (from 3 months)
    • Examples: bandages, syringes, dental mirrors

    Complex products

    (Class 2b and 3)

    • High risk to the patient
    • Additional testing is required
    • Lengthy registration process

      (6 months and up)

    • Examples: pacemakers, implants, ventilators

    It is important to determine the correct product class!

    An error at this stage will result in registration rejection and loss of time.

    Contact us, and we'll
    to determine the class of your
    free of charge!

    Simple and complex medical devices:
    what's the difference?

    Preparation of a complete
    a package of documents:

    We develop all necessary documents for registration of medical devices, taking into account the current requirements of regulatory authorities.


    The preparation time depends on the complexity of the product
    and it takes two weeks.

    Analysis and adjustment
    of existing documentation:

    If you already have prepared materials, our experts will analyze them in detail and make the necessary revisions to meet regulatory standards.

    Advice on requirements
    of the regulatory agencies:

    We will explain all the nuances and help you understand the complex issues related to registration and certification.

    Full support
    of the registration process:

    We not only develop documents, but also take care of the entire procedure of medical device registration.


    You will receive a registered product without bureaucratic complexities and delays.

    Individual approach to each client

    The foundation of our work. We carefully analyze the specifics of your product

    and strategize the preparation of documents, taking into account the possible

    post-registration risks. Our team consists of specialists with experience in

    More than 15 years in the field of medical device registration, which guarantees high
    level of professionalism and competence.

    You want to know how long it's gonna take
    document preparation for
    of your product?

    Leave a request and we will give you an accurate estimate
    timing and cost!

    Our rates

    For KZ producers

    Package

    "Super Start."

    Start-up of MI production from scratch to obtaining the RI in installments with a reliable partner

     What's included?

    • Preparation of all documentation from scratch
    • Support in obtaining a license
    • Development of standards, technical reports
    • Laboratory tests
    • Submission of documents and receipt of 1 registration certificate

    Bonus: 50% discount

    for a second registration in the same production line.

    490 000 KZT/month.

     (12 months)

    Package

    "Personalized." 

    This is the solution for projects with special
    requirements.

     What's included?

    • Preparation of all documentation from scratch
    • Support in obtaining a license
    • Development of standards, technical reports
    • Laboratory tests
    • Submission of documents and receipt of 1 registration certificate

    Cost: is calculated individually after project analysis.

    For foreign manufacturers

    BLUE

    to get a head start on the market

     What's included?

    • Registration of up to 3 medical devices per year
    • Consulting support
    • Profitable start with a reliable partner

    350 000 KZT/month.

     (12 months)

    SILVER

    for high-growth businesses

     What's included?

    • Registration of up to 10 medical devices per year
    • Personal project manager
    • Annual consulting support
    • Economy 4 600 000 KZT compared to one-time registrations

    890 000 KZT/month.

     (12 months)

    GOLD

    for large-scale deliveries

     What's included?

    • Unlimited number of registrations during the year
    • Personal project manager
    • Discount 10% on all company services
    • Economy

      1 690 000 KZT/month.

    1 690 000 KZT/month.

     (12 months)

    Discounts

    -5% when paid 6 months in advance,
    -10% if paid 12 months in advance

    Experts

    15 Years of Experience

    Diana Arys

    Founder, expert in document development

    "If she takes on something, she does it well and to the point. Always."

    10 Years of Experience

    Olzhas Akhmetsadyk

    Founder, expert in medical device registration

    "I am convinced that success comes through Partnership and Expertise"

    What makes us different from others

    Quality assurance
    and meeting deadlines:

    We appreciate your evil time and
    strive to get the job done
    efficiently and in a timely manner
    timelines.

    Process transparency
    and constant
    Communication:

    You will always be aware of the current
    project status and be able to
    promptly respond to
    emerging issues.

    More than 400 successfully
    realized projects:

    Our experience is confirmed
    numerous cases
    and satisfied customers.

    Certification of Experts

    Our projects

    Non-woven Surgical Linen

    Band-aids

    Infusion Systems

    Masks, Respirators

    Syringes

    Endoprostheses

    Blood containers

    Antiseptics

    A total of over 400

    of registered Medical Devices

    Customers About Us

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