Safety and quality assessment in Kazakhstan

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Safety and quality assessment in Kazakhstan

The main aim is to confirm the safety and quality of medicines and medical devices in the Republic of Kazakhstan

Medical devices manufactured in the territory of the Republic of Kazakhstan and imported to the territory of the Republic of Kazakhstan are subject to safety and quality assessment

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

Collection, analysis, and execution of the documents provided

Development of local documents and assistance in the development of documents according to the list

Organization of assessment of production conditions and products quality assurance system

Translation of documents

Registration stages

According to the current rules in the Republic of Kazakhstan, safety and quality assessment includes the following stages:

  1. Collection of documents

  2. Registration of the certificate

  3. Registration of the applicant

  4. Signing the agreement

  5. Submission of an application

  6. Expert examination of the documents

  7. Assessment of conditions

  8. Assessment of the samples

  9. Testing

  10. Paperwork and registration

  11. Issuance/denial

Service cost

State license fee

5 MCI (monthly calculation index)

The final cost and terms will be calculated at your request

Questions and Answers

1. How is the document calculated?

1. Why do medical devices undergo testing?

1. Is it possible to suspend or revoke the registration certificate of a medicine?

2. What is the period of registration of a medicine?

3. When is it not possible to conduct clinical or preclinical trials?

1. List of documents required for registration

1. List of documents required for registration

1. Which documents are required for registration?

1. Which documents on the status of pharmacovigilance activities are required to be submitted?

2. Are illustrations, images and graphics included in the calculation of a document?