Your product
is awaited!
Registration
Medical Device
On Turn Key basis
What medical
devices are subject to
registrations
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
01
Initial Diagnostics of source documents - FREE of charge from LIMI Consulting Service
02
Dossier collection
03
Submission of an application to the RSE for PCV "NCELS and MI"
and contracting
04
05
06
07
Safety Opinion
08
What determines the cost?
Medical Registration
Products
01 Type of registration: National or under EAEU rules
02 Product type
03. Country of manufacture
04. Address of the production site
05. Will there be an audit
06. Providing product samples and quantities
07. 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
Package solutions for registering medical devices in installments
up to 12 months
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. значительно оптимизировать затраты.
work with a wide range of
product range
bring products to market in stages
want to reduce costs and lower the workload on your internal team
Package solutions save our customers money
from 4 500 000
millions of tenge per year
The registration process for each
MI in package solutions is absolutely identical to the standard service:
- 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
- Non-woven Surgical Linen
- Band-aids
- Infusion Systems
- Masks, Respirators
- Syringes
- Endoprostheses
- Blood containers
- Antiseptics
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