Medical devices and medical equipment of foreign manufacture may be imported and placed on the market of the Republic of Kazakhstan after state registration. The Application for registration may be submitted both under the “national” and under the “centralized” procedure of the EAEU.

A non-resident manufacturer must designate the Authorized representative in the territory of Kazakhstan, regardless of the selected procedure. The Authorized representative of the manufacturer must be a resident legal entity that bears primary responsibility for the quality and safety of the medical device, as well as serves as the storage location for the documentation and the point of contact with the manufacturer:

authorized representative of the manufacturer is a legal entity or individual registered as an individual entrepreneur, and is a resident of the Republic of Kazakhstan, authorized by the Power of Attorney from the manufacturer of the medical device to represent his interests regarding the circulation of the medical device in the Republic of Kazakhstan in accordance with the current legislation of the Republic of Kazakhstan in the field of healthcare;

Contact details of the authorized person for adverse event (incident) monitoring in the Republic of Kazakhstan must be included to the Application for registration.

The procedure for national registration is described below. The description of the procedure for registration of medical devices within the framework of the Eurasian Economic Union is provided on a separate page of our website.

The national procedure of state registration

National procedure of state registration of medical devices in Kazakhstan is established by following legal acts:

• Order of the Minister of Health and Social Development of the Republic of Kazakhstan No. 735 “On approval of Rules for state registration, re-registration and amendments to the registration dossier of medicinal products, medical devices and medical equipment” dated November 18, 2009;
• Order of the Minister of Health of the Republic of Kazakhstan No. 736 “On approval of the Rules for the examination of medicinal products and medical devices” dated October 18, 2009;
• Order of the Minister of Health of the Republic of Kazakhstan No. 764 “On approval of the Rules for classification of the safety of medical devices and medical equipment” dated November 24, 2009.

The competent authority performing expert activities of registration of medical devices and medical equipment is National Center for expert evaluation of medicinal products, medical devices and medical equipment.

Non-resident manufacturer must also designate (authorize) the Applicant at the territory of Kazakhstan for registration purposes. The Applicant is the representative of the manufacturer authorized to submit an Application, documents and materials for the expert evaluation of the medical device for registration purposes. 

National legislation separates medical devices and medical devices for in vitro diagnostic, but that does not affect the registration procedure. 

Medical devices are classified according to the Order of the Minister of Health of the Republic of Kazakhstan No. 764 dated November 24, 2009, depending on the degree of potential risk into 4 classes: I, IIa, IIb and III. The class of the medical device affects the list of registration dossier documents for expert evaluation of the medical device, as well as the volume and terms of expert evaluation.

An Application for registration may include several medical devices that meet the following criteria:

• devices (modifications) have common constructive features, common functional purpose, belong to one class of potential risk of application;
• production is carried out by one manufacturer;
• modifications of the medical device have uniform operating and servicing rules.

The dossier is submitted in the national format, consists of a wide list (about 38 items) of administrative and technical documents. The list of documents depends on the class of medical device, purpose and characteristics.

The registration dossier may be submitted in English, with the translation of some sections into Russian. 

The Application for registration and the registration dossier materials are generated in electronic form, in the information system of the state expert organization. 

Expert evaluation of medical device consists of the following stages:

1. Initial expert evaluation (registration dossier validation): evaluation of the completeness, sufficiency and correctness of documents, checking the availability of necessary samples and materials.
2. Laboratory testing of a medical device (not carried out for medical equipment: using apparatuses, instruments or equipment): conducting physicochemical, biological and technical testing in order to confirm compliance with safety and quality parameters of the medical device.
3. Specialized expert evaluation:
   1. expert evaluation of documentation in order to provide a conclusion on safety, efficacy (productivity) and quality;
   2. inspection of manufacture in cases stipulated by the legislation of Kazakhstan, namely, by the Order No. 743 “Rules for evaluating the manufacturing conditions and the quality assurance system during state registration of medicinal products, medical devices and medical equipment”.
4. Generation of a summary report on the safety, effectiveness and quality of the medical device, part of which is posted on the internet resource of the competent authority, issuance of a Registration Certificate.

During the expert evaluation, the competent authority may ask questions or make the observations (deficiency letters) to which the Applicant must respond within a term not exceeding 60 calendar days. The response time for repeated questions or observations is 30 calendar days.

The Registration Certificate is issued for a period of 5 years (or indefinitely) and is valid only in the territory of Kazakhstan.

Language and labeling requirements

The package labeling and instructions for medical use (user manual) are submitted and approved in Russian and Kazakh.

The requirements for the instructions for medical use and the patient leaflet were approved by Order of the Ministry of Health of the Republic of Kazakhstan No. 414 “The Rules of creation and execution of instructions for medical use and the general characteristics of medicinal products and medical devices” dated May 29, 2015.

The requirements for the labeling of medical devices are approved by Order of the Ministry of Health of the Republic of Kazakhstan No. 227 “On approval of Rules for labeling of medicinal products and medical devices” dated April 16, 2015.

Samples of graphic design artworks (package mock-ups) are approved during the registration procedure and placed on the website of the competent authority.

Changes and amendments

During the validity of the Registration Certificate MAH can apply for changes/amendments procedure. The list of amendments to the registration dossier of the medical device not requiring new registration:

• Change of information on the manufacturer/manufacturing site of a medical device/medical equipment.
• Change of information on the authorized representative, including information on re-organization of a legal entity, change of its name, change of surname, name, patronymic name (if any), residence address of individual entrepreneur.
• Change in the name of the medical device and/or medical equipment.
• Change in the composition of supplies and (or) components and (or) consumables, software update (installing a new version).
• Change in the indications for use, domain of usage, contraindications, adverse effects.
• Change of the manufacturers of the components, supplies, consumables.
• Increase/decrease of the shelf-life of the medical device.
• Change in the storage conditions.
• Change in the quality control procedure for the finished medical device.
• Change of medical device packaging; primary packaging of medical devices; secondary and/or multiple packaging, transport, intermediate packaging.
• Change of prints, primers or other markings, stamps and inscriptions, including the addition or alteration of the paint used for labeling of medical device.

Other amendments or changes require new registration procedure.

Renewal of registration 

The Application for re-registration is submitted before the expiration of the Registration Certificate.

Upon completion of the renewal procedure for medical devices manufactured in accordance with the requirements of ISO 13485, an indefinite Registration Certificate is issued.

Cratia provides professional services of registration of medical devices in Kazakhstan. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.