Conducting clinical trials of medical devices

In what cases are not carried out

Before a new product or medicine is put on the market, it is extensively tested. This is to make sure that it is safe. The final study of a product is clinical or clinical-laboratory trials. These take place on live patients. Volunteers are involved in such studies. What are they and why are such tests needed? Volunteers need a particular product for health reasons. The main purpose of such a study is to find the newest and safest solutions for patients. Both the manufacturer, the expert body and the clinic are involved in this process.     

For Kazakhstan, the basic rules for conducting clinical trials of medical devices are described in CR-DSM-248. In paragraph 1, the cases in which it is necessary to conduct clinical trials are clearly stated. In other cases, when registering MIs that have registered analogs in the state register, the expert body adopts a review of clinical trials. This document includes the study of literature publications and evidence that the medical product is not an innovation, and the use of analogs is already practiced. An obligatory section in the review is a comparative table, where it is necessary as a comparison to use the names that have state registration in Kazakhstan. Our team lcs-kz.com for over 5 years has been developing such reviews for domestic manufacturers to successfully pass the state expert review. Submission of these surveys is also not obligatory for Class 1 and 2a products, if there are no drugs in the composition.

Requirements

Any clinical trials for medical devices shall be performed after preliminary proof of their safety and biocompatibility under laboratory conditions and if the following conditions are met:

- the goal is to obtain new scientific results

- confidentiality regarding participants is respected

- There is written consent for the participation of the patient or his/her representative and for the use of biospecimens for scientific purposes.

- there is a permit of the authorized body. Issued by the National Center of Expertise

- favorable opinion of the ethics committee

- Patient life and health insurance and provision of the relevant policy

- registration in the National Biomedical Registry.

Organization of clinical trials of medical devices adheres to the research protocol and plan. The sponsor notifies the authorized body of the start and end of the research and all results obtained and monitors the process itself.

After obtaining expert approval, clinical trials of medical devices can be carried out in treatment centers with appropriate licenses, in accordance with ISO 14155:2014 and EEU regulations. However, they must be started no later than one year after authorization. Clinical and laboratory tests are provided for IVD medical devices (EEU Decision No. 29).

Obtaining approval

Authorization to conduct clinical trials of medical devices is issued prior to a safety study of products not previously studied. For example:

- Class 2b and 3 implants

- Medical products, the principle of action, purpose and application of which have not been previously studied

- modifications of already registered medical devices, but differing in functional characteristics, peculiarities of use and not previously studied

- products containing new materials that have not previously been studied for biocompatibility.

In order to obtain approval from the expert body, the applicant must enter into a contract and submit the following list of required documents, in accordance with paragraph 21 of the Order: 

- A cover letter, with detailed information about the product being studied and a unique number assigned by the sponsor.

- application for conducting, filled out in the form of Annex 7 of the Order

- information about the researcher (treatment institution) in accordance with GCP standard requirements

- medical product technical file

- the protocol (plan) to be followed clinical trials of medical devices. The plan should include information on the number of samples required, approval of the scientific organization and sponsors. If pregnant women and minors are planned to participate, a scientifically validated opinion on the appropriateness and safety of such tests should be provided in addition.

- list of foreign bases where similar applications for the study of the claimed product have been submitted (only if available)

- registration card

- researcher's confirmation of participation

- researcher's CV

- copy of the insurance policy contract

- list of auxiliary products needed for the tests

- A power of attorney for clinical trials of medical devices from the sponsor to the applicant, in cases where they are different people

- commission opinion 

- proof of payment of state duties

After submitting the package of documents, the National Center analyzes the documents and proceeds to the evaluation of the materials. In case of an incomplete package of documents, it issues a comment to the applicant, which must be responded to within 60 days. The final result of the whole procedure is the issuance of a conclusion on the expediency of conducting a QI in the Republic of Kazakhstan. The conclusion is provided within 30 days.