What medical devices are subject to registration in the Republic of Kazakhstan?

To answer this question, we first need to refer to the Health Code and other Orders that define the term. In the Code there is a definition of medical devices where the presence of medical assistance is important. Information about this is included in the manufacturer's instructions for use. Products can be - materials, solutions, reagents, kits, sets, equipment or complexes that provide medical assistance. However, this may not be sufficient to determine the exact status.

How to determine which medical devices are subject to state registration?

To solve this problem, we at the company lcs-kz we use the recommendations of the EAEU board number 25. The document is very useful for making decisions and planning tasks. In the recommendations you can find a list of medical devices subject to state registration, with a detailed breakdown by groups. Products are categorized according to their intended use.

Product groups

Let's take a closer look at each group in detail and give real-life examples. 

1. Cosmetic and personal care products used for medical purposes. For example, breast pumps for the prevention and treatment of breast diseases; heating pads to reduce pain; diapers, pads, diapers for people with impaired genitourinary function; photo and laser hair removal equipment. All these are medical devices subject to registration.

And if the products are intended only for care, for example, for skin, hair, lips, nails, they are not registered.

2. Means and equipment for disinfection. Equipment for air purification in medical institutions, for obtaining sterile instruments, alcohol wipes can be classified as mi subject to registration. in Kazakhstan. 

However, the following do not need to be registered: goods against pediculosis, for insect control.

3. Household products such as televisions, monitors, printers, refrigerators do not need to be registered.

4. Products for people with disabilities undergoing rehabilitation. An important point in this product group is that the individual needs of the patient should be covered by corrective functions.

For example, cases when registration of medical devices is required: prosthetic limbs, hearing aids, wheelchairs, special shoes with orthopedic properties. 

5. Products for sports and exercise practice may include items that reduce pain through cooling or heating, restore muscle stretching, and diagnose causes of disease.

There are a number of other devices from the sports sector that can measure heart rate during physical activity, can count the distance traveled, and so on. These medical devices are not subject to registration.

6. Personal protective equipment is generally products that protect patients or staff from exposure to infections (masks, respirators, gloves, goggles, suits) or radiation (lead aprons and suits). 

All other personal protective equipment not intended for medical purposes does not need to be registered.

7. If the software provides medical assistance, is able to work autonomously, both as part of medical equipment and separately from it, and as a result of its work provides data in automatic mode, then this software needs to be entered in the state register.

8. Techniques and packaging materials for storing medical products. In this case, we are talking about materials that are designed to preserve the properties of products, such as airtightness, sterility, etc.

In group 3, it was mentioned that refrigerators are not subject to registration, however, there are refrigerators for storing medicines and products and for maintaining specific conditions. In this case, medical equipment is subject to registration.

9. Physical therapy equipment that does not use natural materials must be registered. And products that are not subject to can include mineral waters, stones, cedar barrels, saunas.

10. Furniture that is used in special rooms for procedures and operations, for which surface treatment is applicable, belongs to medical products. For example: couches, tables, beds, multifunctional chairs.

11. products with drugs in their composition. To categorize products into this group, it is important to know the type of its effect on the patient's body. If the mechanism of operation is not pharmacological or metabolic, but mechanical or physical, it is necessary to prepare a dossier and register as a medical product.

Conclusion

Using the recommendations of the EAEU, it became possible for everyone to independently carry out preliminary work to study the status of registered products.

If, after using the recommendations, the status of the product is still not clear, you can use a paid service of affiliation with an expert authority. Based on the results of the examination, the authority will give an official letter confirming the status of the product.