MedExpert Eurasia O.O.O of Moscow at MEDICA 2017 in Düsseldorf -- COMPAMED Trade Fair

MedExpert Eurasia O.O.O

7 Khlebozavodsky Proezd, Building 9, 115230 Moscow
Russian Federation

Telephone +7 776 2500555
info@medexpert.co

This company is co-exhibitor of
CONCORD BUSINESS SERVICE Ltd.

Hall map

MEDICA 2017 hall map (Hall 12): stand F46

Fairground map

MEDICA 2017 fairground map: Hall 12

Our range of products

Product categories

  • 06  Information and communication technology
  • 06.01  Archiving and documentation

Our products

Product category: Archiving and documentation

Registration of medical equipment and medical devices

Registration of Medical Equipment and Medical Devices: Medical Support
The period of our company's becoming a recognized partner in the medical business coincided with the period of professional growth for our team as well. Now we are the best experts and know how to obtain authorization documents for registration of medical equipment, medical devices and medicines in the territory of the Republic of Kazakhstan, Kyrgyzstan, Tajikistan and Uzbekistan.

From our working experience in this field we know that not all applicants are ready for establishing and maintaining relations with the public authorities directly engaged in the expertise activities for medical products of national and foreign manufacturers. The whole registration process takes a lot of efforts and time starting from a dossier preparation followed by amendments introduction including closing any comments at every expertise stage till its completion involving registration of medical devices or medical equipment in the state register.

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Product category: Archiving and documentation

Medicines

The state registration of medicines is a prerequisite for the introduction of new medicines in the pharmaceutical market of the Republic of Kazakhstan.

The state registration and re-registration covers medicines produced in the Republic of Kazakhstan, as well as those registered in the country of origin imported into its territory, including:

  • medicine bearing trade names specifying a dosage form, dosage, filling;
  • bulk pharmaceuticals imported into the Republic of Kazakhstan;
  • new combinations of medicines previously registered in the Republic of Kazakhstan specifying a dosage form, dosage, filling;
  • medicines previously registered in the Republic of Kazakhstan but produced by other organizations in other dosage forms with a different dosage, filling, new packaging, a different composition of excipients and a under different name.

The following products are not subject to the state registration:

  • medicines prepared in pharmacies;
  • drug substances produced in accordance with Good Manufacturing Practices.

The state registration, re-registration and variation of registration dossiers is performed by a state authority in the area of drugs, medical devices and medical equipment circulation (hereinafter the Committee or the State agency).

The expert examination of medicines is performed by a state expert organization in the area of circulation of pharmaceuticals, medical devices and medical equipment, which is not directly involved in the design and manufacture of the medicine in question (hereinafter NCEM or the Expert Organization) under a contract with the applicant.

In the course of the state registration, re-registration and variation of the registration dossier in accordance with order № 735 of the Ministry of Health and Social Development of the Republic of Kazakhstan dated November 18, 2009 “On Approval of Rules for the State Registration, Re-registration and Variation of Registration Dossiers of Medicines, Medical Devices and Medical Equipment" the expertise of medicines  involves the following steps:

  1. Initial expertise;
  2. Analytical expertise;
  3. Specialized pharmaceutical expertise;
  4. Specialized pharmacological expertise;
  5. Safety, efficacy and quality-related conclusions 

Each subsequent stage of the expertise of a medicine is carried out on the basis of the positive conclusion of the previous stage.
Below is the list of documents required in the course of the expertise of medicines:

  1. The list of documents of the registration dossier provided in the course of the expertise of medicines in the Republic of Kazakhstan in the format of the Common Technical Document (for medicines manufactured under the Good Manufacturing Practice);
  2. The documents of the registration dossier provided in the course of the expertise of medicines manufactured under rules other than the Good Manufacturing Practice;
  3. A list of documents required for dossier variation;

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Product category: Archiving and documentation

Licensing

Licensing services:

  • for pharmaceutical activities and paid medical services;
  • for selling, repair and import of X-ray equipment;
  • for importation of medical equipment, medical devices and medicines;

The Law of the Republic of Kazakhstan “”On Licensing” has been amended according to the Law of the Republic of Kazakhstan “”On Amendments to Certain Laws of the Republic of Kazakhstan on Health Care Issues” signed by the President on July 16, 2009. According to this Law the wording of the type of activities “the pharmaceutical activities: production, manufacture, whole and retail sale of medicines” was amended to read as follows: “”pharmaceutical activities” and divided into subtypes of activities.

According to Article 26 of the Law of the Republic of Kazakhstan “On Licensing", the following subtypes of pharmaceutical activities are subject to licensing:

  • whole sale of medicines;
  • whole sale of medical devices;
  • whole sale of medical equipment; retail sale of medicines;
  • retail sale of medical devices;
  • retail sale of medical equipment.

Entities performing pharmaceutical activities are chemist's shops, pharmacies, pharmacy depots, temporary storage warehouses for medicines, optic stores, stores of medical equipment and medical devices, warehouses for medical equipment and medical devices, laboratories for certification and testing of medicines, medicines manufactures.

Licensing services are provided by the Ministry of Health of the Republic of Kazakhstan. In accordance with Order No.47 of the Minister of Health of the Republic of Kazakhstan dated 22.04.2005 “On certain licensing issues” the pharmaceutical activity licensing function was transferred to the Departments of Health Care of regions, in Astana, to the Department of Economics and Budget Planning of the Mayor in Almaty city. Subjects of licensing are individuals and legal entities operating in the field of medicines that meet the qualification requirements to the licensing of pharmaceutical activities. One of the documents required to obtain a license for pharmaceutical activity is an expert opinion issued by the bodies of the Department of Supervision Committee for Sanitation and Epidemiology of the Ministry of Health of the Republic of Kazakhstan and the Fire-Fighting Service on the applicant's compliance with qualification requirements provided for in the course of licensing of such type of pharmaceutical activity. The license for pharmaceutical activities shall be considered to be general without any limitations of the validity term.

Any individuals wishing to perform types of pharmaceutical activities subject to licensing without establishing a legal entity shall have an academic degree in pharmacy.

Import License

Any X-ray equipment including X-ray tubes (irrespective of a country of origin) except for replacement parts and appliances shall be imported to the Republic of Kazakhstan under the import license.

Any import or export license shall be regulated by Law of the Republic of Kazakhstan No.579 “On certain licensing issues of goods export and import” (see clause 1 + subclause 3) where the import license procedure and the list of the required documents are specified.

According to the import licensing procedure an application with a package of documents shall be sent to the Industry Committee of the Ministry of Industry and New Technologies of the Republic of Kazakhstan for further delivery to certain state bodies for approval.

The validity of an import license is one year.

The list of goods the importation of which is approved by the Committee of Nuclear Energy is provided for by Decree No.104 of the Government of the Republic of Kazakhstan dated February 5, 2008 “On Approval of the List of Goods Subject to the Export Control” supplemented by the list of “The Goods Controlled on the Grounds of National Safety and under International obligations” (enacted on 10.01.2013 according to Decree No.1320 of the Government of the Republic of Kazakhstan dated 17.10.2012) that includes X-ray equipment.

The list of goods subject to automatic import licensing is approved by the Government of the Republic of Kazakhstan. The list of goods to be licensed for export and (or) import:

  • Ionizing radiation sources and isotopes, X-ray alpha-, beta-, gamma- or neutron radiation equipment (X-ray equipment, tubes, mammographers and other generators of X-ray radiation);
  • X-ray equipment, devices and equipment with use of radioactive substances and isotopes (radiographic systems).
Commodity Nomenclature.

Any organizations using X-ray equipment or register it shall receive a license for “Operation of plants generating ionizing radiation" (licensed by the Committee of Nuclear Energy).

Suppliers of X-ray equipment do not need a license to sell X-ray equipment, since this kind of activity is excluded from the Law “On Licensing".

One application for licensing may only contain unlimited number of various types of X-ray equipment if it has the same code of foreign economic activity (CN FEA), i.e. for each CN FEA one application form is filled in

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Product category: Archiving and documentation

Medical Metrology

In most cases medical equipment and devices have standardized metrological characteristics, and therefore they are measurement instruments.

That is why medical measurement instruments, as well as industrial gages shall be subject to a thorough metrological study, i.e. testing, certification and calibration after production thereof.

The main purpose of any metrological service is to provide the uniform measurement.

The uniform measurement is a state of a measurement process when the results of all measurements are expressed in the same legalized units of measurements, and their accuracy assessed with the ensured confidence probability.

The works to ensure uniform measurements in Kazakhstan are regulated by the Law "On ensuring the unity of measurements" of the Republic of Kazakhstan. The law prohibits to market, use, sale and advertise any measurement instruments not tested for the type approval or for metrological certification. For this reason all medical measurement instruments imported into the territory of Kazakhstan shall now be registered in the State System for Ensuring Uniform

Measurement of the Republic of Kazakhstan.
On the basis of the approved RK standards any measurement instruments intended for batch manufacture or import into the territory of Kazakhstan in batch quantities shall be subject to testing with the later type approval; any measurement instruments produced or imported in single quantities and subject to state metrological control shall be certified.

Measurement instruments manufactured in the CIS countries that are parties to the Agreement for mutual recognition of state testing results and type approval, metrological certification, control and calibration of measurement instruments as well as results of laboratories accreditation testing, controlling and calibrating measurement instruments shall be subject to the procedure of recognition of state testing results and type approval of the measurement instruments.

The state activities to ensure the uniform measurements are managed by the authorized standardization, metrology and certification authority of the Republic of Kazakhstan.

The State System for Ensuring Uniform Measurement shall cover the following objects: measurement units, state standards of measurement units, standards of measurement units, measurement instruments, and measurement instrument calibration methods, requirements to the measurement instruments, methods and results, methods of measurements, metrological service activities of the state administration bodies, individuals and entities for ensuring uniform measurement.

Metrology. Registration in the State System for Ensuring Uniform Measurement of the Republic of Kazakhstan

According to Cl. 1 of Article 17 of the Law "On ensuring the unity of measurements" of the Republic of Kazakhstan any measurement instruments intended for batch manufacture or import into the territory of Kazakhstan in batch quantities shall be subject to testing with the later type approval.

The procedure for measurement instrument testing for type approval:
An application for testing for type approval of measurement instruments shall be submitted to the Committee for Technical Regulation and Metrology of the Ministry of Industry and Trade of the Republic of Kazakhstan.

The following documents shall be attached to this application by an applicant:

  • testing program plan or plan of amendments and/or additions to a standard program;
  • manufacturer's document package containing the complete technical and metrological characteristics;
  • verification procedure plan in compliance with the State Standard of the RK 2.63 when the section regulating verification means and methods is not provided;
  • type description methods draft in the form according to Annex D to the ST of the RK 2.21-2007 with general view photos 13x18 or 18x24 in duplicate;
  • the applicant's letter with permission to publish the type description in mass media;
  • information on availability of calibration instruments for measurement instruments during their operation in the Republic of Kazakhstan, as well as information on the companies and organizations for service maintenance and repair work;
  • documents justifying the recommended calibration interval.
 

All documents of a foreign manufacturer shall be submitted together the version of the text translated into the official and/or Russian language.

The application with the document package shall be submitted to RSE ''KazInMetr” for execution. RSE "KazInMetr” concludes an agreement for measurement instrument experimental testing for type approval with the organization submitting the application.

Testing of measurement instruments for type approval shall be carried out according to the testing program developed in compliance with requirements of the RK ST 2.6-2003 "Testing programs for type approval of measurement instruments. Main requirements”” agreed with the applicant and approved by the authorized body or a state scientific metrological center or under the standard testing program as supplemented or amended as provided for by the established procedure.

The authorized body (Committee) for Technical Regulation and Metrology shall make a decision about the measurement instrument type approval on the basis of the measurement instrument test results to approve the type and to confirm the compliance with the approved type. This decision shall be supported with a type approval certificate for measurement instruments in the form specified in the Annex A to the RK ST 2.21 -2007 with the validity terms not exceeding 5 years.

Metrological certification of measurement instruments

Measurement instruments produced or imported in singular quantity and subject to the state metrological control shall be metrologically certified. The decision about metrological certification of measurement instruments shall be supported by a standard metrological certificate issued for measurement instruments with the validity defined upon issuance.

Testing of measurement instruments for type approval and confirmation of the compliance with the approved type, as well as metrological certification of measurement instruments shall be carried out by a state metrological service.

Approved type of measurement instruments and measurement instruments having passed the metrological certification shall be entered into the register of the state system for ensuring uniform measurement.

Measurement instruments operated and stored after the expiry date of the type approval certificate can be used until complete depreciation

Recognition of test results
Test results and type approval shall be recognized in compliance with the requirements of the Rules of International Certification 06-2001 "The Procedure for Mutual Recognition of Test Results, Type Approval, Calibration and Metrological Certification of Measurement instruments”.

Measurement instruments manufactured in the CIS countries shall be subject to the Procedure for recognition of test results and type approval.

To follow this procedure it is necessary to submit an application to the State Committee for Standardization and Metrology and provide the following documents package:

  • a copy of the type approval certificate for measurement instruments legalized by the manufacturing plant;
  • a copy of the type description
  • operating documents;
  • calibration procedure;
  • a form of the verification certificate for measurement instruments after production and (or) a reprint of a verification mark.

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Product category: Archiving and documentation

Biologically Active Additives

BAA are, like any other products, subject to obligatory state registration. The state registration/re-registration of Biologically Active Additives in our country is performed by the Committee for Sanitary Inspection of the Ministry of Health through the Advisory Council on the basis of the Kazakh Academy of Nutrition, LLP.

For certification and registration of BAA of interest visit the website of the National Center for Expertise of Medicines, Medical devices and Medical Equipment of the Ministry of Health www.dari.kz.

A Joint List of goods was approved by Decision № 299 of the Customs Union Commission dated June 18, 2010, as are subject to sanitary-and-epidemiological supervision (monitoring) at the customs border and customs territory of the Customs Union, which was supplemented by BAA. Since еру entry into force of the Customs Union Agreement on Sanitary Measures on July 1, 2010, the procedure for BAA certificates registration and processing has been amended

The registration procedure includes the following steps:

  1. Sanitary and hygienic analysis (analysis of compliance of ingredients composition, physico-chemical parameters, determination of the content of heavy metals, radionuclides, pesticides, mycotoxins, microbiological analysis and the analysis of toxic effects on human body in acute experiments on laboratory animals).
  2. The expert examination of the dossier submitted by the manufacturer, the expert council on the basis of the Kazakh Academy of Nutrition.
  3. Assignment of a registration number, recording in the register of goods registered in the Republic of Kazakhstan by the Sanitary Inspection Committee of the Ministry of Health.

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About us

Company details

MedExpert is a partner to rely upon in addressing issues of medical equipment and medical products registration in Kazakhstan. After many years of successful and flawless work in the healthcare market the company grew into a recognized leader in the area of registration, certification and licensing of medical products and medical equipment not only in Kazakhstan, but also far beyond its borders. In 2015 we launched our own medical equipment calibration laboratory.

Our team of experts is constantly improving its business skills with due account of the market growth and technology development and is always ready to offer something new to its customers.

Today we can say with certainty that the project has surpassed the wildest expectations of its founders, due to the well thought-out strategy and innovative approach.

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