- Consultation regarding import grounds and applicable import formats;
- Preparation and review of the dossier;
- Accurate submission of the electronic application;
- Interaction with competent authorities;
- Support through final permit issuance.
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Import Permit Application Process
Participating Authorities
Legal Basis and Import Requirements
The following authorities participate in the import permit issuance process:
- Quality and Safety Control Committee for Goods and Services of the Ministry of Health of the Republic of Kazakhstan;
- Territorial Departments of the Quality and Safety Control Committee for Goods and Services of the Ministry of Health of the Republic of Kazakhstan.
Timeframes and Key Features
The procedure includes the following stages:
Grounds for Obtaining an Import Permit
1. Submission of an Electronic Application
Completion and submission of an application for an import permit in accordance with the requirements of Order No. 293 of the Ministry of Health of the Republic of Kazakhstan through the electronic portal.
2. Dossier Review
Assessment of the submitted dossier for compliance with qualification requirements by the Quality and Safety Control Committee for Goods and Services.
3. Issuance of the Permit
Signing of the import permit by the Chairman of the Committee and publication of the document on the elicense.kz electronic portal.
Grounds for Obtaining an Import Permit
1. Submission of an Electronic Application
Completion and submission of an application for an import permit in accordance with the requirements of Order No. 293 of the Ministry of Health of the Republic of Kazakhstan through the electronic portal.
2. Dossier Review
Assessment of the submitted dossier for compliance with qualification requirements by the Quality and Safety Control Committee for Goods and Services.
3. Issuance of the Permit
Signing of the import permit by the Chairman of the Committee and publication of the document on the elicense.kz electronic portal.
Grounds for Obtaining an Import Permit
An import permit for medical devices may be issued in the following cases, among others:
- Implementation of innovative medical technologies;
- Procurement of medical devices by the Single Distributor from international organizations established by the United Nations General Assembly and/or prequalified by the World Health Organization;
- Importation of components that form part of a medical device and are not intended for independent use;
- Provision of humanitarian aid in cases established by the Government of the Republic of Kazakhstan;
- Provision of medical care based on vital indications for a specific patient or a limited group of patients with rare and/or particularly severe diseases;
- Prevention and/or mitigation of the consequences of emergency situations;
- Participation in medical device exhibitions without the right of subsequent sale;
- Conduct of state registration, re-registration, and amendments to the registration dossier;
- Conduct of clinical investigations.
Issuance period: up to 5 business days
Submission format: electronic
Validity period of the permit: unlimited
Submission format: electronic
Validity period of the permit: unlimited
An Import Permit is an official document granting the right to import pharmaceutical products and medical devices into the territory of the Republic of Kazakhstan in cases provided for by applicable legislation.
In accordance with Article 71 of the Code on Public Health and Healthcare System of the Republic of Kazakhstan, both medical devices manufactured in the Republic of Kazakhstan and medical devices imported into its territory are subject to state registration and re-registration.
If a Registration Certificate is not available and there is a justified need, a one-time permit for the importation of unregistered medical devices may be issued.
The permit issuance procedure is regulated by Order No. 293 of the Minister of Health and Social Development of the Republic of Kazakhstan dated April 28, 2015 On Approval of Public Service Standards in the Field of Pharmaceutical Activities.
In accordance with Article 71 of the Code on Public Health and Healthcare System of the Republic of Kazakhstan, both medical devices manufactured in the Republic of Kazakhstan and medical devices imported into its territory are subject to state registration and re-registration.
If a Registration Certificate is not available and there is a justified need, a one-time permit for the importation of unregistered medical devices may be issued.
The permit issuance procedure is regulated by Order No. 293 of the Minister of Health and Social Development of the Republic of Kazakhstan dated April 28, 2015 On Approval of Public Service Standards in the Field of Pharmaceutical Activities.
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