Safety and quality assessment

in Kazakhstan

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Safety and quality assessment

Service available for:

  • 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

Problems of independent Safety and Quality Assessment of Pharmaceutical Products and Medical Devices:

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

Advantages of working with MedExpert on Safety and Quality Assessment of Pharmaceutical Products and Medical Devices:

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

The final cost and terms will be calculated at your request

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Questions and Answers

1. Which documents must be submitted to obtain a certificate of conformity for products in Kazakhstan?

1. List of documents OBK declaration
2. List of OBK documents for serial production
3. List of OBK documents of each series (batch) of products
4. Order No. 269 On the Approval of the Rules for Conducting OBK Drugs and MI from 05/20/2019
5. Cost and terms