Peculiarities of registration of medical devices for in vitro diagnostics.

In Vitro Diagnostic (IVD) products are products that test health conditions without coming into direct contact with the body. These products analyze human biological material and provide narrowly focused results.

What refers to medical devices for in vitro diagnostics?

There are many tests that are used daily by medical professionals or in the home, which are medical products for in-vitro diagnostics. These include pregnancy tests, alcohol tests, drug tests for all types of drugs, reagents for the detection of various diseases, and PCR tests. Such products also include medical equipment that performs diagnostics. For example, blood/urine analyzers, equipment for histological analyses and even some laboratory equipment. According to the legislation of Kazakhstan, even products that are used in conjunction with such MIs are also classified as IVDs. But here it is necessary to approach without fanaticism and not to include indirect products here. We are talking about devices for taking test substances. Spatula probes, blood tubes, collection containers, etc.

What is the peculiarity of MI registration for in vitro diagnostics?

The registration of medical devices for in vitro does not differ in process from the usual state registration or within a union. The stages of registration of MI for invitro diagnostics are identical to the usual process. If from the very beginning, collection of the dossier, submission to NCELS, three or four types of examination and issuance of a registration certificate.
However, the registration of this type of products has peculiarities in the list of required documents in the dossier. If we now go to the Order on national registration of CR-DSM-10 and refer to the list in Annex 2, we will see that there the other products are divided into risk classes, and in-vitro products stand apart. Although these products are also divided into risk classes, the requirements are the same for all of them.

The main, perhaps the main, difference that catches the eye when collecting at once is the requirement to have ISO 13485. For other MIs, ISO 13485 is not required for all. For IVD products, on the other hand, the presence of ISO is mandatory for any risk class, regardless of sterility. Further, the reports for IVD products have a completely different look than for conventional MIs. The products are tested for specificity and analytical sensitivity, as well as subjected to clinical and laboratory testing, not to mention that the stability of these products is studied in a different format and the approach to its study is highly dependent on the recommended storage conditions. These three reports are mandatory for registration. However, it should be understood that specificity and sensitivity test reports are not provided for containers, tubes and other laboratory ware.

If we are talking about medical equipment (analyzers and other electrical devices) for in vitro diagnostics, it is additionally necessary to test the product for electromagnetic compatibility and safety. For MI intended for radioimmunoassay it is also necessary to provide radiation safety reports in the presence of ionizing radiation.

There is also a separate type of IVD equipment, the so-called "closed type". This definition means that such equipment works together with certain reagents and consumables that cannot be replaced by others. Such "closed type" is subject to all the same requirements as other IVD products, only additionally all reports on their consumable and unique components are provided. "Closed" type of technique must be confirmed both by the manufacturer's letter and by the operating document and other official data.

Learn more about the registration procedure for in vitro diagnostic medical devices from our specialists at lcs-kz.