Your product
is awaited!
Registration Medical Device
On Turn Key basis
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
Your product
is awaited!
Registration Medical Device
On Turn Key basis
Medical devices subject to state
registration – these are products for use in
hospitals, homes, ambulances, in
medical offices
Syringes
Systems
Bandages and gauze
Pregnancy tests
MRI machines
Lighting fixtures used in operating rooms
ECG machines
X-ray equipment
The software used in these devices
Dental offices
Disinfectants used in operating rooms
Respirators with special protection class, hospital furniture, etc.
REGISTRATION PROCESS
Initial Diagnostics of source documents - FREE of charge from LIMI Consulting Service
Dossier collection
Submission of an application to the RSE for PCV "NCELS and MI"
and contracting
Initial examination
Specialized expertise
Laboratory tests
Safety Opinion
Obtaining a Registration Certificate
What determines the cost?
Medical Registration
Products
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 uses a stage - where we do Initial Diagnostics using 4 documents + expert consultation up to 30 minutes
FREE
For companies that plan to regular supply medical devices for registration, we offer batch support
— with a fixed monthly payment instead of a one-time service.
If you register more than 3 MI annually, these solutions will allow you to significantly optimize costs.
Individual project manager — one contact person, full coordination of all processes
Ongoing expert support — access to consultations at all stages of the project
Orderly registration management — transparent process and status control without loss
Reduced risk of errors and returns — working strictly in accordance with regulatory requirements
Efficiency of execution — adherence to deadlines and regular reporting on the progress of work
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 License is received
We offer document development as needed, no middlemen, no outsourcing, no overpayments
Respond to comments and inquiries from the state body and make adjustments
Calculating the number of samples
We provide consulting support at all stages
If you want to register your MI in Kazakhstan, Uzbekistan, Russia - leave an application form
PRINCIPLES OF CONSCIOUS
REGISTRATION
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
Etc.
A total of more than 400
of registered Medical Devices
English 
Russian