Language and labeling

The procedure for labeling of medical products is approved in accordance with Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-11 of January 27, 2021 "On Approval of the Rules of Labeling and Traceability of Medicines and Labeling of Medical Products".

Requirements to the instruction for medical use and patient insert sheet are approved by Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-101/2020 of September 10, 2020. "On Approval of the Rules for Drafting and Execution of Instructions for Medical Use of Drugs and Medical Products and General Characterization of a Medicinal Product".

Pursuant to the specified regulatory documents, the text of the Medical Product Instruction shall be drawn up in Kazakh and Russian languages, shall be clear and comprehensible with indication of the sequence of actions on the application.
Labeling shall be uniform for each series (batch) of a medical product and shall also be indicated in the state and Russian languages.

Registration of medical products in Kazakhstan

Registration of medical products in Kazakhstan constitutes an important and obligatory step in ensuring the safety and quality of medical products available to the consumer. Through the registration process, medical product manufacturers can demonstrate that their products meet the highest standards of safety and efficacy. Thus, the manufacturer gets the right to sell its goods in the Kazakhstan market, which is a growing and dynamic market with significant potential for growth.

1. When registering a medical product – 5, 6 months;
2. When making changes to the Registration Dossier of a medical product – 3, 4 months;
3. Accelerated examination of medical products (re-registration) – 30 working days.

The competent authority conducting expert work for the registration of medical devices and medical equipment in Kazakhstan is the National Center for Expertise of Medicines, Medical Devices and Medical Equipment. The management of the Electrontest group of companies and the management of the RSE on the REM "National Center for Expertise of Medicines and Medical Devices" of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan signed a cooperation agreement.

At the moment, it is possible to obtain registration of a medical product for the purpose of its circulation in the territory of the Republic of Kazakhstan under the following provisions:

1. Preparation of the Application and compilation of the Registration Dossier. Submission of a set of documents to the authorized body for subsequent registration, including:

• Application and Registration Dossier;
• Confirmation of payment under the contract by the applicant to the settlement account of the state expertise organization of the amount for expert examination;
• Medical product samples.

2. Initial expertise of a medical product.
At this phase, the completeness, completeness and compliance of the documents of the Registration Dossier submitted by the applicant with the requirements of the current legislation with regard to the evidence of safety, quality and efficiency of the medical product are assessed.
Timeline for initial expertise:
In case of Class 1 and Class 2a medical product expertise – not more than 10 calendar days.
In case of Class 2b and Class 3 medical product expertise – not more than 20 calendar days.
If there are any comments arising, then a letter shall be sent to the applicant stating that they must be addressed within a period not exceeding 60 calendar days.

3. Specialized expertise of a medical product.
The expert assessment and analysis of registration dossier documents confirming safety, quality and efficiency of medical products in accordance with Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-10 of January 27, 2021 is carried out.
Timeline for specialized expertise:
In case of Class 1 and Class 2a medical product expertise – not more than 40 calendar days (including confirmation of authenticity or translation into Kazakh of labeling of package layouts, labels, stickers, instructions for medical use);
In case of Class 2b and Class 3 medical product expertise – not more than 70 calendar days (including confirmation of authenticity or translation into Kazakh of labeling of package layouts, labels, stickers, instructions for medical use).
If there are any comments arising, then a letter shall be sent to the applicant stating that they must be addressed within a period not exceeding 60 calendar days.
If additional questions arise concerning the information provided by the applicant in the response to the previous request, the applicant shall, within 30 calendar days of receipt of the request, send a response and necessary materials to the additional request to the state expert organization.

4. Laboratory testing of a medical product.
In case of successful passing of the specialized expertise, laboratory tests of the medical product samples are carried out in the testing laboratories of the "National Center for Expertise of Drugs and Medical Products" with a view to confirm compliance with the safety and quality indicators of the medical product declared in the quality document.
The following is included in the scope of the laboratory testing:

• Analysis of the technical and regulatory documentation of the medical product in terms of test methods;
• Testing of medical product samples;
• Determination of the reproducibility of the test methods.

Timeline for laboratory testing:
In case of Class 1 and Class 2a medical product expertise – not more than 30 calendar days (including confirmation of authenticity or translation into Kazakh of labeling of package layouts, labels, stickers, instructions for medical use);
In case of Class 2b and Class 3 medical product expertise – not more than 60 calendar days (including confirmation of authenticity or translation into Kazakh of labeling of package layouts, labels, stickers, instructions for medical use).
If there are any comments arising, then a letter shall be sent to the applicant stating that they must be addressed within a period not exceeding 90 calendar days.
When is it not necessary to perform laboratory testing?
1. When performing an expertise on medical products;
2. When there is a document from a notified body on the full compliance of the medical product manufacturing and quality control system with the requirements of the Directives of the European Commission for Medical Products;
3. When performing an expertise of a medical product manufactured at the production sites of manufacturers originating from the European Union and (or) the United Kingdom, the United States, Canada, Japan or Switzerland, authorized for circulation by the regulatory authorities of the European Union, the United Kingdom, the United States, Canada, Japan or Switzerland;
4. When re-registering a medical product;
5. When performing a quick expertise of a medical product.

5. If necessary – inspection of the production site;
The main purpose of the inspection is to assess manufacturers of drugs and medical products as to whether their production complies with the standard of good practice of the Republic of Kazakhstan or the Eurasian Economic Union and International Standards (ISO).
Forms of inspection:

• Initial inspection is carried out during the expertise of medical products of 2a (sterile), 2b and 3 class of potential risk of use of manufacturers who have not previously registered products in the Republic of Kazakhstan or have not previously supplied products from production sites in the Republic of Kazakhstan;
• Periodic (scheduled) inspection of facilities once every 3 years;
• Unscheduled inspection.

The scope of inspection also depends on the degree of potential risk of medical products. For instance, for medical products of risk class 3, the design and development processes of the product will additionally be assessed.
The results of the inspection shall constitute an integral part of the Registration Dossier of medical products and shall be taken into account during the formation of the expertise results.

6. Formation of the outcome documents of the performed medical product expertise.
Upon completion of the expertise, the applicant shall within 30 calendar days agree with the authorized body the information on the medical product and the final documents (instructions for medical use and labeling of package layouts, labels, stickers), including the accuracy of the recorded data. In case of lack of approval by the applicant after the expiration of the thirty-day period, the conclusion on safety, quality and efficiency of the medical product shall be formed without approval of the applicant;

Based on the results of the performed expertise of the medical product, the state expert organization shall draw up a conclusion on safety, quality and efficiency of the medical product, which shall be valid for 180 calendar days.

7. Submission of the registration application, confirmation of payment of the state duty and a copy of the conclusion on the safety, quality and efficiency of the medical product in electronic form to the Ministry of Health of the Republic of Kazakhstan. Obtaining an indefinite registration certificate.

Our task

By entrusting the task of registration of your medical product to us, you can be sure that we will ensure successful registration throughout the EAEU: in the Republic of Kazakhstan, in the Russian Federation, in the Republic of Belarus, in the Republic of Kyrgyzstan and in the Republic of Armenia.

We provide professional assistance in the development, adjustment and preparation of all necessary documents of the Registration Dossier, the key ones being:

- Application for state registration of a medical product;
- Information on the regulatory documentation for the medical product;
- Technical documentation of the manufacturer (producer) for the medical product (extract from the technical file/technical specifications, risk management file, manufacturer's reports, qualification test reports);
- Operational documentation of the manufacturer (producer) for the medical product;
- Documents confirming the technical testing results of the medical product;
- Documents confirming the toxicological test results of the medical product;
- Documents confirming the medical product test results for the purposes of type approval of measuring instruments;
- Documents confirming the clinical efficacy and safety of medical products.

The group of companies "Electrontest" includes its own testing base, namely: technical testing laboratory of IL TSB LLC "Electrontest"; toxicological testing laboratory "ElectrontestBio", the main activity of which is testing of medical devices and medicines for biological safety, as well as a clinical diagnostic laboratory accredited for conducting technical, clinical tests of MI in vitro. The powers of all laboratories are confirmed by relevant documents. We guarantee that all tests, if necessary, will be carried out at the highest level, and the test results will be obtained in accordance with all necessary requirements and within a clearly defined time frame.

Electrontest LLP in its work relies on many years of experience of its employees in the registration of medical devices in the Republic of Kazakhstan and the Russian Federation. We provide a comprehensive approach to the registration process. If necessary, we, together with the testing centers of the Electrontest group of companies, provide the full range of tests of medical devices necessary for their registration: technical, toxicological, clinical and clinical-laboratory tests of In Vitro products.

The timeframe for the medical product expertise is not included in the timeline:

• Time to make amends for an incomplete Registration Dossier;
• Time to provide documents and materials upon request during the examination within the established deadlines;
• Time to prepare for and conduct a medical product inspection;
• Reconciliation of final documents
Validity period of the registration certificate: Indefinitely

Phases of registration of medical products in Kazakhstan

You can save precious time and money by working with us, as we will undertake the preparation of all necessary documentation in accordance with the requirements of regulatory documents and regulatory bodies, as well as support the registration process after the submission of documents to the National Center of Expertise.

Astana, st. Anet baba, 9/3

+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225

Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.

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Contacts

_{For request:}
electrontest.kz@gmail.com