The new article provides additional details regarding the specific aspects covered by the scope of the new regulation on clinical trials for medical devices.
The new regulation related to clinical trials for medical devices has been adopted recently in Turkey. The scope of the regulation covers the matters related to the way clinical trials should be carried out to ensure the accuracy and reliability of the results. Apart from this, provisions thereof prescribe the approach to be applied concerning the activities carried out by conformity assessment bodies. The regulatory requirements outlined in the document should be strictly followed by medical devices manufacturers, conformity assessment bodies, healthcare institutions and professionals, and other parties involved in the clinical evaluation of medical devices intended to be marketed in Turkey.
Cancellation of Certificates
The document describes, inter alia, the situations when an authorization certificate of the conformity assessment body or a working certificate granted to a healthcare professional could be canceled.
According to the guidance, an authorization certificate granted to a conformity assessment body could be canceled in case:
- The assessment body fails to appoint a person responsible for the assessment, who has the relevant experience and qualifications;
- The way the activities are conducted creates additional risks for the life and health of the persons involved;
- The assessment body has suspended its activity without notifying the authority as prescribed by the respective regulation;
- Dissolution or bankruptcy of the entity.
At the same time, the working certificate of a healthcare professional could be canceled in case if:
- The reports prepared by the healthcare professional are inaccurate or falsified;
- The certificate has been temporarily suspended three times within five years;
- A healthcare professional continued performing the activities during the period when the respective certificate has been suspended;
- The actions committed are falling outside the scope of the certificate; and
- The activities are carried out in a way exposing the persons involved to additional risks.
It is important to mention that once the personal work certificate has been canceled, such a person cannot apply for a new certificate for three years.
Apart from the matters described hereinabove, the document outlines certain specific aspects to be considered by medical device manufacturers, conformity assessment bodies, and other parties involved in activities related to clinical evaluation. The scope of the regulation covers, inter alia, the following aspects:
- Notification requirements. A conformity assessment body should duly notify the regulating authority about the changes to the personnel, address, as well as to hardware, software, and accessories used. The appropriate notification should be submitted within twenty business days from the date the changes took place. Moreover, an assessment body should also provide the authority with detailed information regarding the activities undertaken by the scope of authorization within ten business days from the date of such request.
- Changes to the scope. Should a conformity assessment body decide to make changes to the scope of certification, the appropriate request should be submitted to the authority. Such a request should be accompanied by all the relevant information the authority would reasonably need to review the request and make its decision.
- In case of force majeure events, the authority may implement additional requirements or take other actions beyond the scope of the present regulation.
- Transfer of a conformity assessment body. The regulation allows the authorization to be transferred from one entity to another and prescribes the appropriate procedure to be followed in such cases. It is important to mention that if such transfer does not result in changes to the hardware, software, or accessories used, an additional on-site inspection would not be required. The authority will review the documentation provided and notify the applicant about the approval of the transfer, and the appropriate certificate will be issued. It is explicitly stated that in case the activities of the initial entity have been suspended, the transfer cannot take place unless the suspension period will expire. Should the transfer result in changes to the address, a notification should be submitted accordingly.
- Sanctions. The parties violating the regulatory requirements set forth herein could be subject to sanctions as set forth by the applicable legislation including, inter alia, the country’s Criminal Code.
- Transitional Provisions.
- To be eligible for applying for a work certificate, an interested person should have at least three years of experience in quality control tests in the field of diagnostic radiology, nuclear medicine, and radiotherapy group medical devices in the last five years as of the date the present regulation has been published. The said experience should be duly confirmed by the respective documents. It is also stated that the scope of certification should be limited to quality control tests. Apart from this, an applicant should work within the organization (conformity assessment body) dealing with the respective type of medical devices.
- To be eligible for applying for a work certificate related to the use of X-ray imaging systems, an applicant should complete the appropriate training course within 24 months before applying.
- The parties involved in operations with medical devices should ensure compliance with the regulatory requirements outlined in the present regulation within the specific term indicated therein – two years for radiotherapy group devices and three years for diagnostic radiology and nuclear medicine group devices. At the same time, the said period could be extended upon request of the healthcare institution for a maximum of three years for diagnostic radiology group devices.
In summary, the present regulation sets forth the requirements in the sphere of clinical evaluation of medical devices of different types. The document is intended to prescribe the procedures to be followed before medical devices will be allowed for marketing and use in Turkey to ensure compliance with the applicable safety and performance requirements.
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