Who needs an import and export authorization for medical devices in Kazakhstan?

The main rules are specified in the Order of the Ministry of Health of the Kyrgyz Republic DSM-237/2020. These rules are used by those who import and export medicines and medical devices, including medical equipment. 

Why you need an import authorization for medical devices

The Health Code of Kazakhstan tells us that all medical devices imported into the country must have a registration certificate. That is, registration of medical devices is required. However, there are a number of cases when the importation of unregistered medical devices is allowed. This procedure is called one-time import of medical devices, and it is done for a limited number of units. Such authorization is issued by the Committee for Medical and Pharmaceutical Activities in an online format. 

We (lcs-kz.com) have prepared a breakdown, in which we will explain what goes along with the issuance of the permit you need and help you find the right solution.

Document preparation

In order to import products without RI into Kazakhstan, the applicant must submit a completed annex from the Order. More specifically, No. 5. It is then sent to the state body by egov. In order to obtain approval for import, you indicate one or more reasons for importing such products. According to the legislation, there are 9 cases for which there is a possibility of single import:

1. Providing medical care to patients with a rare or complicated disease. It is obligatory to have a letter of confirmation from a medical institution. 

2. To deal with the consequences of emergency situations. It is necessary to provide data from the local authority on preventing the results of emergency situations and on the exact quantity of required products. The applicant shall provide a letter of guarantee on labeling the imported product in the state and Russian languages. 

3. Provision of humanitarian aid. The letter from the applicant specifies the receiving party and the quantity of goods to be sent. Also attached is a letter of assurance that the local public health authority will control the process and that the items will not be used for commercial purposes.

4. Launch of new technologies. Confirmation of the relevant authorities on the necessity of such introduction shall be provided. Detailed information and documents on product quality and safety (certificates of analysis, declaration of conformity, etc.) are obligatory.

5. Procurement by a single distributor of products from international companies approved by the UN, WHO, etc. Organizations for which such products are imported must have the appropriate license. Namely, for medical activities (hospitals, medical centers, etc.).

6. For the expert body for registration purposes. The application form should be accompanied by a letter from the expert body requesting samples, specifying the exact number. Such a letter can be obtained by obtaining the service "Calculation of samples" from the expert body itself. It is provided free of charge, within 14 days. To obtain such a letter, it is necessary to provide NCELS with a normative document for the product (with requirements and methods). Important: Without the normative document you will be rejected after 14 days and you will have to re-submit the application.

7. Use of samples at exhibitions, without further sale. Here the confirmation will be a letter from the organizer of the exhibition where you participate.

8. Supplies from the composition of a medical product. But this applies to consumables not intended for independent operation. Most often we are talking about the importation of medical equipment into Kazakhstan. That is, we have a RU for the medical equipment itself with accessories, but the components in its composition do not have separate certificates. But we need these components to, for example, repair the equipment. We don't need to import the whole equipment, do we? We can make a one-off import.

9. Conducting clinical trials or approbation of products. We need the Committee's approval to initiate such trials. 

Who needs a permit to export medical devices from Kazakhstan

To answer the question, the Order will not help us, but we can again refer to the Health Code. It is stipulated there that the export of any medical devices and equipment for the purpose of export requires approval. It is issued by the Committee. However, there are cases when authorization for the export of medical devices is not required:

1. Products for personal use

2. Products included in the first aid kit

3. Returns after exhibitions or clinical examinations

4. exports within the EAEU space (Kyrgyzstan, Belarus, Russian Federation and Armenia)

Tracking and timelines

The whole process of obtaining an authorization is transparent. After submitting the necessary documents, you have the opportunity to check the stages of service provision through your personal cabinet, where the dates and stages of work are displayed. The Committee reviews the package of documents and issues the permit in 3 working days. The result comes in electronic form. The cost of public service is 0 tenge, i.e. the service is completely free.

Grounds for refusal

After receiving all documents and checking them for completeness, the state body has the right to refuse authorization on certain grounds. This may happen if the set of submitted data is incomplete, contains errors, or if there is a court decision regarding the service recipient's activity. The reason for the refusal is always specified in the text of the refusal, therefore, after the elimination of the identified violations, it is possible to reapply.