Your product
waiting!
Registration of Medical Devices in Kazakhstan
Under the Key
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+7 (708) 500 10 56
Your product
waiting!
Registration of Medical Devices in Kazakhstan
Under the Key
Medical products manufactured in Kazakhstan and imported into its territory are subject to state registration. These products can be used at home, in hospitals, ambulances and medical offices. Among them:
Syringes, bandages, gauze, systems
Rapid tests for various purposes
MRI, ECG, X-ray machines and other medical equipment
Operating room luminaires
Equipment for dental offices
Software for medical devices
Disinfectants, respirators with special protection class
Hospital furniture, etc.
REGISTRATION PROCESS
Initial diagnostics of source documents - FREE of charge from LIMI Consulting Service
Dossier gathering. We help you assemble the necessary set of documents, taking into account the specifics of the medical device
Submission of an application to the RSE for PCV "NCELS and MI" and conclusion of a contract
Initial examination. Assessment of completeness and correctness of the documentation presented in the registration dossier
Specialized expertise. Examination of the registration dossier to assess the safety, efficacy and quality of a medical device
Laboratory Testing. Conducted to verify safety, efficacy and compliance with requirements
Safety conclusion
Obtaining a registration certificate for a medical device in the Republic of Kazakhstan
What does the Cost of Registration of Medical Practitioners depend on?
Products and Techniques in Kazakhstan
Type of registration: National or under EAEU rules
Product type
Country of manufacture
Address of the production site
Will there be an audit
Providing product samples and quantities
Volume of language translations of documents
To answer these questions LIMI Consulting Service has the first stage - where we do Primary Diagnostics on 4 documents + expert consultation up to 30 minutes
FREE
What is included in the Service
Turnkey registration of Medical Devices in Kazakhstan from
LIMI Consulting Service
Collect and analyze the dossier taking into account post-registration risks together with the manufacturer
We submit the documents to the state body and follow the expert examination until the RU is received
We offer document development as needed, no middlemen, no outsourcing, no overpayments
Respond to comments and inquiries from the public body and make adjustments
Calculating the number of samples
We provide consulting support at all stages
PRINCIPLES OF MINDFULNESS
REGISTRATIONS.
LIMI Consulting Service
We work comprehensively
We help you from obtaining a Pharm License to Registration Certificate
Sharing responsibility
We take post-registration risks into account already when collecting the dossier
We work fast
Our manager will always be in touch with you
No overpayments
All experts are full-time employees, not outsourced, so we set realistic prices for high quality
Guarantees
Transparency of the process and quality of the documentation developed
Diana Arys
founder, expert
on the development of documents
"If someone promises to register your Medical Device in 3 months, be aware that it is difficult to make changes to such a Registration Certificate afterwards,
which means your product's marketability is at risk."
OUR PROJECTS
Non-woven Surgical Linen
Band-aids
Infusion Systems
Masks, Respirators
Syringes
Endoprostheses
Blood containers
Antiseptics
A total of more than 300
of registered Medical Devices
English 
Russian