What is important to know when registering medical devices in Kazakhstan?
- If a company enters the market of the Republic of Kazakhstan for the first time, an ISO 13485 inspection is required (inspection can be carried out during the registration process or before it starts) * inspection is not carried out for medical devices of risk class I, IIa non-sterile
- To avoid problems during the medical device import, you need to agree layouts and IFUs before printing and packaging
- Before registration, it is necessary to have a company that will be responsible for the quality and safety of medical devices on the KZ territory
Stages of work
- Signing a non-disclosure agreement (if necessary)
- Checking the dossier for completeness
- Invoicing for 50% payment of services (prepayment)
- Medical device samples calculation by Ministry of Health (for analytical testing)
- Dossier preparation for submission
- Expertise (elimination of additional requests, 13485 inspection organization, if necessary)
- Registration certificate issue
- Invoicing for remaining 50% payment of services
Registration terms
- Registration 4-7 months
- Re-registration 2-4 months
- Alteration (making changes) 1-4 months (depends on the type of changes)
Note: The terms are indicated as realistic as possible based on our experience.
