1. National State Registration for medical devices (see below).
2. EAC MED mark – single market for medical devices (by link).

National regulation system | Regulatory framework

Code of the Republic of Kazakhstan of September 18, 2009  On Public Health and  Public Health System.

Order of the Minister of Health of the Republic of Kazakhstan No 735 of Novemer 18, 2009 On approval of the Procedure of state registration, re-registration and amendments to registration dossier of medical products (drugs), medical devices and equipment.

Order of the Minister of Public Health of the Republic of Kazakhstan № 736 of November 18, 2009 On Approval of the Procedure of Expertise of Medicinal Products, Medical Devices, and Equipment.

Order of the Minister of Public Health of the Republic of Kazakhstan № 743 of November 19, 2009 about approval of assessment regulations of manufacturing conditions and quality assurance system during state registration of drug products, healthcare products and medical equipment.

| Main scheme for first entry into a market

Stage 1. You send request for quotation to BeAWire.

Stage 2. Pre-clinical trials is chemical, physical, biological, microbiological, pharmacological, toxicological, and other experimental scientific trials or series of studies for examination of the product under study or physical effect of drugs, methods, preventive measures and methods, diseases diagnostics and treatment for the purpose of appraisal of the specific effect and(or) safety with regard to human health (by 735 order).

Stage 3. Clinical trials is a trial of medical devices and with a human subject carried out to determine and confirm the safety and efficiency of drugs, preventive methods and techniques, diseases diagnostics and treatment (by 735 order).

We can avoid real trials providing if manufacture protocols are good or on the ground of Russian protocols for example.

Stage 4. List of documents of registration dossier is formed based on safety class. Documents of registration dossier must include an authentic translation of all the documents into Russian. BeAWire submits electronic dossier in NC by http://www.dari.kz.

Documents KZ registation

Stage 5. Before state registration, re-registration and amendments the expertise should be done. The expertise is performed by National Center for drugs and Medical Devices Expertise (NC).

The expertise consists of 3 stages:

• primary expertise:
• analytical expertise;
• special expertise.

Each successive stage of expertise is carried out on basis of the positive conclusion of the previous one.

Stage 6. Factory inspection is provided mostly in two cases: first entry into a market and in case with medical devices which required special condition for installation and maintanance (MRI, X-Ray).

Stage 7. For the registered medical devices and equipment the governmental body issues marketing authorisation and hands the following documents within ten calendar days:

1) approved instruction for medical application of medical devices and equipment in the national and Russian languages;

2) approved packages and labels designs for medical devices.

Stage 8. Electronic registration certificate is valid for 5 years.