Registration confirms that a medical device complies with established safety and efficacy standards, ensuring the protection of patients' health and the safety of medical personnel.
- Compilation of the registration dossier
- Conclusion of a contract with the RSE on REM "National Center for Expertise of Medicines and Medical Devices" (NCEEMD)
- Submission of the application to the RSE on REM "NCEEMD"
- Preliminary expertise: evaluation of completeness and accuracy of the documentation submitted in the registration dossier
- Specialized expertise: review of the registration dossier to assess the safety, efficacy, and quality of the medical device
- Laboratory testing: conducted to verify safety, efficacy, and compliance with established requirements
- Conclusion on safety: verification of final documentation
- Issuance of the registration certificate
Registration certificates issued in accordance with the regulations of the Republic of Kazakhstan are valid indefinitely.
An import permit is required in the following cases:
- Provision of medical care to patients with rare diseases
- Response to the consequences of emergencies
- Delivery of humanitarian aid
- Registration, re-registration, and amendments for medical devices and medicinal products
- Registration of dietary supplements and cosmetics
- Development of regulatory documentation and instructions for use
- Translation of documentation
- Obtaining import permits for samples of medical devices/medicinal products for laboratory testing
- Obtaining approval letters for the import of dietary supplement samples for laboratory testing
- Determination of classification as a medical device
- Licensing of import, medical, and pharmaceutical activities
- Obtaining Declarations of Conformity, safety and quality approvals
- Reference pricing for medicinal products and analysis of ceiling prices for medical devices/technologies
- Certification of medical specialists
- Obtaining permits for advertising