The main purpose is to ensure the uniformity of measurements in the Republic of Kazakhstan and the release into circulation of measuring instruments that meet the requirements of the technical documentation of the manufacturer’s plant
Examination of technical and metrological characteristics of measuring instruments and assessment of their compliance with the readings established in the technical documentation through experimental studies
You will have a lot of work, the nuances of which are unknown to you:
The procedure may take a long time
You may not know the details of the regulatory environment
You may not know the nuances of communication in regulatory bodies or in the country
We will undertake all the routine work.
You save time and therefore money
We have a team of professionals in different areas of regulatory affairs
We select individual solutions for each project
We guarantee confidentiality
We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the registration process
List of services
Conclusion of contracts with the authorized body
Development of a test program in conjunction with an authorized body
Provision of samples for testing
Development of materials according to the ST of the RK 2.21-2017
Interaction with authorized bodies
Translation of the documentation
Obtaining an approval certificate for the type of measuring instrument
Stages of approval of the type of measuring instrument
According to the current rules in the Republic of Kazakhstan, the approval of the type of measuring instrument includes the following stages:
Expert examination of
the technical documentation
Experimental studies to
approve the type
Coordination of materials at
the technical council of KazInMetr RSE
Signing of the certificate of
approval of the type of measuring instrument
State license fee
5 MCI (monthly calculation index)
We will calculate the final cost and terms of registration at your request
Questions and Answers
1. How is the document calculated?
Documents are calculated in characters. One page equals 1800 characters with spaces.
1. Why do medical devices undergo testing?
that the product meets the declared technical characteristics, does not pose a
danger to human health, and has clinical effectiveness
1. Is it possible to suspend or revoke the registration certificate of a medicine?
Yes, registration is canceled if the registration certificate expires or if this medicine has not been in circulation for more than 3 consecutive years. In addition, its effects may be revoked in the following cases:
• new risks or side effects were found during use;
• information specified in the certificate changed (information about the manufacturer, dosing, and form);
• the manufacturer submitted a request to cancel the registration
1. Kazakhstan Drug Registration Process
2. Kazakhstan List of documents for VIRU-LS
2. What is the period of registration of a medicine?
By law, the registration period is determined as follows:
If you have a complete package of documents, 210 calendar days, not including
the preclinical period, the period of clinical trials, the time to eliminate
remarks, and inspection of the manufacturing site
3. When is it not possible to conduct clinical or preclinical trials?
the drug is registered and in circulation for more than 20 years. In all other
cases, clinical trials are a mandatory part of the procedure.
1. List of documents required for registration
List of documents required for the provision of public services on application of an Applicant (or his/her representative by power of attorney) according to the technical regulations of the Customs Union: List of documents-dietary supplement
1. Which documents are required to obtain an import license for medical equipment in Kazakhstan?
According to TR CU 009/2011 requirements, for state registration, it is necessary to submit the following:
• an application
• samples of labels and packages
• certified copies of technical documentation (enterprise standard and instruction)
• documents confirming the quality of the product and compliance with the claimed characteristics
• acts and reports of accredited laboratories and research centers
• copies of documents about all essential attributes of a product (organoleptic, physical, microbiological, chemical, etc.)
• annotations with all information about the properties of the specified preparation, instruction for use, and precaution
• manufacturer’s founding documents