The National Center for Expertise of Medicines and Medical Devices (NDDA), a country’s body responsible for the assessment of quality and safety of medical devices, has published an official notice describing the newly adopted methodology of expert assessment of the optimal technical characteristics and clinical-technical justification of medical devices.
The appropriate Order has been adopted by the Minister of Healthcare of the Republic of Kazakhstan on January 5, 2021. The Order repeals the previous regulation on the same matter dated May 29, 2015. The new Order enters into force in 10 calendar days from the date of its initial publication.
The methodology of expert assessment of the optimal characteristics of medical devices (hereinafter – the “Methodology”) was developed in accordance with the general rules set forth by the Code of the Republic of Kazakhstan “On public health and healthcare system” dated June 7, 2020. The rules and requirements set forth by the present Methodology should not be applied in the case of products with the intended medical purpose which is not considered as medical devices under the applicable legislation.
According to the order, an expert assessment of the optimal technical characteristics should be conducted with regard to the new medical devices and equipment which have not been used before and manufactured not later than 24 months before. As usual, such an assessment should be conducted prior to the procurement of medical devices for healthcare institutions, or for purposes related to free medical services and mandatory social medical insurance.
The document provides the definitions of the most important terms used in the context of an expert assessment addressed therein. For instance, the concept of the medical device covers both medical devices and medical equipment. The definitions provided in the document include, inter alia, the following ones:
- Clinical-technical justification – a document containing the information on the actual need in medical equipment requested, and also on the readiness of a healthcare institution to use it;
- Components of a medical device – parts of a medical device, that do not constitute separate medical devices themselves, including blocks, parts, elements, materials, spare parts provided by the medical device manufacturer to be used for the intended purpose;
- Medical equipment – apparatus, devices, equipment, complexes, systems used separately or in connection with each other for the provision of medical care in accordance with the intended purpose and operating characteristics determined by the manufacturer;
- Applicant – a natural or legal person submitting an application, documents, and materials for the expert assessment;
- Expert conclusion for medical equipment – a document issued by an expert organization in accordance with the present Methodology, necessary for planning and organization of medical devices procurement.
According to the applicable regulation, an expert assessment of the optimal technical characteristics and clinical-technical justification of medical devices should be conducted by an expert organization under the appropriate agreement based on the general principles set forth by civil law.
Methodology of Expert Assessment of the Optimal Characteristics of Medical Devices
In order to apply for the expert assessment described herein, an applicant shall submit to the expert organization the following documents:
- Application for the provision of services in accordance with the appropriate form prescribed by the present order;
- Technical specification covering all the components of a medical device in question separately;
- Clinical-technical justification of procurement of medical equipment in accordance with the form also prescribed by the present Methodology.
Under the general rule, it would take up to 60 calendar days from the date the application was registered for the expert organization to conduct an expert assessment. In case of any reasonable concerns or objections, an expert organization would send a letter to the applicant. Upon receipt of such a request, the applicant shall take all the necessary actions to repeal the non-compliances identified no longer than within 20 calendar days. Should the applicant fail to make necessary improvements, an expert organization is entitled to suspend the procedure.
An expert assessment of the optimal technical characteristics should be carried out by the means of technical analysis. Technical analysis should be performed in the following ways:
- Identification of the functional possibilities of medical equipment in accordance with the technical specification;
- Comparison of the functional possibilities of medical equipment to the planned medical services indicated in the clinical-technical justification;
- Comparison of the technical characteristics of medical equipment reflected in the technical specification to the medical services indicated in the justification.
The order explicitly prohibits the inclusion of the components intended for performing functions that are not initially intended by the medical device manufacturer.
Upon completion of the technical analysis, an expert organization provides the appropriate conclusion.
The applicant shall be solely responsible for the accuracy, completeness, and reliability of the information contained in the documents to be submitted in the course of the procedure described herein, while the submission of incorrect information creates grounds for refusal in the expert assessment of the optimal technical characteristics and clinical-technical justification for a medical device.
Methodology of the Expert Assessment of the Clinical-Technological Justification for a Medical Device
The present Order also describes the procedures associated with the expert examination of the clinical-technological justification for medical equipment. According to the document, the procedures to be followed are similar to the ones applied in the case of an expert assessment. The Order also provides the coefficients to be used to determine the actual need of healthcare institutions in the medical equipment in question depending on the procedures it is intended to be used in, and also the way the similar coefficients should be calculated in the case of laboratories. The indications used to calculate the aforementioned coefficients include the number of patients requiring the appropriate treatment, the potential changes in this number, and also the expected volume of medical services related to the medical equipment in question. The calculation also takes into account the potential depreciation of medical equipment occurring when it is used for the intended purpose. It is also important to mention that the healthcare institution requesting medical devices shall provide a confirmation stating that it employs the appropriate number of healthcare professionals trained to use the requested medical devices and equipment. In case if the number of such professionals is insufficient, the applicant shall submit a plan indicating the particular steps to be taken to train the necessary specialists. Such a plan should contain the names of the specialists, dates, and terms of training, and also the expenses planned. Moreover, the applicant shall also demonstrate it possesses the premises necessary to deploy the medical equipment requested. This information should be based on the technical requirements provided by the manufacturer.
Summarizing the information provided here above, the present order describes the procedures and processes associated with the expert assessment of medical equipment. In particular, the document outlines the main aspects to be considered by the healthcare institution interested in procuring medical devices for its own internal purposes. The document also indicates the documentation to be submitted by the interested party and further procedures to be performed by the expert organization when conducting the review of a submission.
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