Preparation of a Certificate (Ticket) for the wholesale and retail sale of medical devices Kazakhstan
A permit document through the use of which the wholesale and retail sale of medical devices is carried out.
01
Laws and regulations governing the process of obtaining a Certificate (Ticket) for the wholesale and retail sale of medical devices
1. Law of the Republic of Kazakhstan No. 202-V ZRK dated 16 May 2014 “On Permits and Notifications”;
2. Order of the Minister of Health of the Republic of Kazakhstan dated 17 September 2020 No. KR DSM-104/2020 (ҚР ДСМ-104/2020) “On Approval of the Rules for the Wholesale and Retail Sale of Medicines and Medical Devices”.
Deadlines:
Regulation: 1 working day (excluding the deadlines for addressing concerns);
MedStandard deadlines: 3 working days (from the moment of collection of all documents).
- Equipment intended for diagnostics, prevention, treatment, and rehabilitation, including special software
- Surgical instruments and materials
- Expendable materials, accessories for equipment and devices
- Devices for monitoring health and self-control
- Ophthalmic medical products
- Dental medical products
- Equipment/furniture for special patient care
- Medical products (sterile/non-sterile)
- Laboratory equipment
- Reagents for in vitro diagnostics
- Personal protective equipment
- Other medical devices
02
Procedure STAGES:
01
Collection of documents according to the list
02
Submission of an application through the elicense.kz portal
03
Issuance of a Certificate (Ticket) for the wholesale and retail sale of medical devices
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