Registration of medical devices: the role of certification and testing

Medical devices play a critical role in modern medicine, providing accurate diagnoses, effective treatments and improving patient care. However, in order for these products to circulate in the market, registration and subsequent evaluation are required. These procedures are carried out to ensure product safety and conformity, and testing for the evaluation of MI becomes an important step and a prerequisite for this process (LCS Blog).

The procedure for obtaining a reg. license requires strict compliance with the regulatory rules. Different countries have different laws and regulations governing the legal presence of products in use. This usually involves the submission of documentation related to the product properties, as well as inspections that verify the product's compliance with the established regulatory obligations. This is done either by the manufacturer itself or by agencies engaged for this purpose (LCS-kz).

Tests for the purposes of registration of medical devices are an important stage in the confirmation of conformity. These tests are conducted to verify the effectiveness and compliance of MI with the requirements of international standards. Toxicological tests and technical tests are conducted to determine the possibility of negative effects of the product on the patient's body. Tests for the registration of medical devices are conducted in specialized accredited laboratories using strict protocols and methodologies. However, some of these tests can be conducted at the manufacturer's own facilities, if properly equipped.

In addition to the inspection of finished products, the next step - certification of medical devices - plays an important role in market circulation. It implies confirmation of their compliance with the established norms and conditions declared at the time of registration. This is the stage of post-marketing finding of MI in circulation. In Kazakhstan, this procedure is called quality assessment and implies declaration. However, in order to double-check the reliability of data, once every two years, the regulator takes samples from the circulation for laboratory testing of MI. In case of successful quality confirmation, further circulation is allowed.

One of the main points that experts pay attention to is manufacturing regulations. Manufacturers are obliged to follow strict standards during the manufacture of equipment to ensure its reliability. Compliance with them also helps prevent misuse and minimize the risks of undesirable events.

The registration and certification of medical devices is not only a legal obligation, but also important steps to ensure patient safety and the efficiency of medical practice. By going through these processes, it is possible to be sure that products meet high requirements. This contributes to increasing patient confidence in MI, which ultimately leads to better protection of public health, which is the ultimate goal of the entire healthcare system.