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State registration of medical devices in Kazakhstan

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State registration of medical devices in Kazakhstan

According to the Code of the RK on the health of citizens, the main purpose of registration of medical devices is to guarantee their safety for the health of citizens

During the procedure, the quality of the devices and their compliance with current norms and standards are inspected. Only truly high-quality and efficient medical devices successfully pass all checks and are included in the register

Items for registration

Medical devices manufactured in the RK and imported to its territory are subject to registration including the following:
  • Equipment for treatment, prophylaxis, and rehabilitation

  • Apparatuses for the examination of health status

  • Accessories and consumables for specified equipment

  • Instruments for monitoring and self-monitoring of patient’s health

  • Devices and tools for restoring or changing physiological functions and human anatomy

Only those devices are not subject to the state registration that are manufactured under individual orders and do not go on free sale

What problems may arise if you decide to do the registration yourself?

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

The benefits of registration with the MedExpert company:

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 process

List of services

Consulting

Adding changes to the registration certificate

Adding changes to the registration dossier

Preparation and collection of the registration dossier

Development and analysis of technical documentation

Collaboration with testing centers

Interaction with registration bodies

Organization of factor of production assessment

Obtaining official letters from the state body on the pertaining of the product to medical products

Registration stages

According to the current rules in the Republic of Kazakhstan, the registration of medical devices includes the following stages:

  1. Collection of the dossier
    and receipt of samples

  2. Signing an agreement with
    the state body

  3. Primary expert examination,
    which assesses the completeness, contents, and accuracy of the paperwork submitted by the applicant in the registration dossier

  4. Analytical expert examination,
    including the testing of medical devices samples and determination of the reproducibility of analytical procedures

  5. Inspection of manufacturing of
    medical devices

  6. Specialized expert examination,
    which is implemented by studying the documents of the registration dossier for safety, effectiveness, and quality of medical devices

  7. Safety statement, which generates
    a summary report on the safety, effectiveness, and quality of the medical device

  8. Assigning a registration number
    and issuing a registration certificate for the medical devices

The final cost and terms will be calculated at your request

By pressing the “Send” button, you confirm that you give the company your consent for processing your personal data

Questions and Answers

1. Why do medical devices undergo testing?