Regulatory services in Kazakhstan and the EAEU
We register medical devices and medical supplies, provide services in the field of certification and licensing.
MEDITOR helps distributors and manufacturers of medical devices register and bring a new product to market.
We take care of all the preparations for the launch of medical devices on the market, acting as an intermediary between you and the government agency.
We work for manufacturers and distributors of medical devices in the Republic of Kazakhstan and in the countries of Central Asia.
For whom?
We guarantee
Solutions tailored to your individual requirements.
An attentive approach to your product and immersion in all business processes.
The right document is timely in the right place. We do not tolerate negligence and missed deadlines.
Comprehensive solutions
for your business
for your business
Licensing
Meditor.kz
Sertification
State registration
reliable partner for state registration
of medical devices!
of medical devices!
Recruiting
Outstaffing
Mentoring
Sign up for a free consultation
We will answer your questions in detail
and propose a work plan
and propose a work plan
markets
8
audits and inspections
50+
Registration of medical devices on a turn-key basis.
years of expertise
20
successful projects
1000+
specialists
100+
Our experience
From consultation to entering the market.
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According to the Code of the Republic of Kazakhstan on the Health of Citizens, our main goal is to ensure the safety of the nation's health.
We carefully check the quality of each medical device, making sure that they meet high standards. Only high-quality and effective medical devices go through inspections successfully and are added to the registry.
MEDITOR ensures that medical products get to the market and saves the manufacturer from checks, errors and fines.
MEDITOR company will solve all issues in the field of regulatory affairs: obtaining a registration certificate, licensing, certification of medical devices and products.
Legislation
«
— Adding changes to the registration certificate
— Obtaining a duplicate of the registration certificate
— Declaration and certification
— Analysis of marginal prices
— Clinical and technical justification
— Safety and quality assessment
— Registration of an import permit
— Monitoring of safety, effectiveness, and quality
medical devices and equipment
medicines
food supplements
perfumes and cosmetic products
disinfecting agents
— State registration
Regulatory Affairs in Kazakhstan and the EAEU
Services
Outstaffing
Our specialists are working on a project in your company, immersing themselves in all the subtleties of the product and business processes.
It is suitable for organizations that value control and effectiveness.
It is suitable for organizations that value control and effectiveness.
We translate any technical
and medical documents competently, accurately and on time.
Only professional translators
with linguistics degree and work experience in the field.
and medical documents competently, accurately and on time.
Only professional translators
with linguistics degree and work experience in the field.
Technical translation
We will prepare and guide your specialist through all stages of the regulatory field.
Your team will learn how to get around the «pitfalls» and get prepared for independent work.
Very own educational methodology of the founders of the MEDITOR company based on many years of experience in regulation.
Your team will learn how to get around the «pitfalls» and get prepared for independent work.
Very own educational methodology of the founders of the MEDITOR company based on many years of experience in regulation.
Training & mentoring
Licensing in Kazakhstan
— Registration of a permission for the wholesale and retail sale of medical products
— Licensing of medical activity
— Licensing of pharmaceutical activity
— Licensing of import of medical equipment
— Licensing of activities in the area of nuclear power use
Metrology
— Approval of the type of a measuring instrument
— Metrological qualification
We SHINVA MEDICAL INSTRUMENT CO., LTD, at Xinhua Medical Scientific Zone, Zibo New & Hi-Tech Industrial Development Zone, 255086, Zibo, Shandong, PEOPLE'S REPUBLIC OF CHINA, would like to extend our heartfelt thanks for the professional certification services you provided for our medical products. Your in-depth knowledge and efficient handling of the certification process enabled us to obtain the necessary documentation in a timely...
Shinva Medical Instrument Co., Ltd.
Zhou Xin, Director of International Business Department
Особо хотелось бы отметить высокий профессионализм сотрудников ТОО "MEDITOR", их готовность оперативно решать возникающие вопросы и предоставлять комплексные консультации по всем аспектам регуляторной работы. Мы уверены, что с вашим участием наша компания будет и дальше успешно развиваться на рынке Казахстана и ЕАЭС, и выражаем надежду на продолжение нашего взаимовыгодного...
ТОО “Lojer Medical”
Генеральный директор Альменова М.Н.
On behalf of Shenzhen Lanmage Medical Technology Co., Ltd., I would like to express our sincere gratitude for the exceptional support your team provided throughout the regulatory approval process for our medical devices in Kazakhstan. Your deep expertise in navigating the complex regulatory landscape was instrumental in the successful completion of our project. Your team's meticulous attention to detail, proactive communication, and efficient...
Shinva Lanmage Medical Technology Co., Ltd.
Ryan Zhang, International Director
Компания Алатау Иннотек рекомендует ТОО “MEDITOR COMPANY” В качестве надежного и высококвалифицированного партнера в сфере регуляторных услуг. Мы имели успешный опыт совместной работы во время регистрации медицинских изделий, оценки безопасности и качества, а также в ходе их сертификации. Команда "MEDITOR" проявили себя как эксперты в своей области, которые внимательно...
ТОО “Алатау Иннотек”
Директор Крестев И.Г.
Calculate the cost
of regulatory services
of regulatory services
Kazakhstan
Uzbekistan
Kyrgyzstan
Tajikistan
Georgia
Azerbaijan
Turkmenistan
Belarus
We work
in 8 countries
in 8 countries
We answer your questions, select the optimal solution and make a detailed commercial offer. Since we work in 8 countries, the consultation may either be online and offline.
Free client consultation
Our expert team dives into your business and analyses the products that needs to be brought to market. We study your strengths, review competitors and offer the most profitable positioning.
Product audit
1
MEDITOR collects documents for products, receive samples,
and conclude an agreement
with the state certifying authority.
and conclude an agreement
with the state certifying authority.
Collection of a registration dossier
Verification of documents for the safety, effectiveness and quality. If necessary, we test samples and determine the reproducibility of analysis methods.
Expert examination
2
We issue a summary report on the safety, effectiveness, and quality of the medical device.
Safety statement & report
Assigning a registration number and issuing a registration certificate for the medical devices.
Registration certificate
3
How we work
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