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/Logotype/ EURASIAN ECONOMIC COMMISSION COUNCILDECISIONFebruary 12, 2016 No. 29city of MoscowOn Rules for Clinical and Clinical Laboratory Trials (Studies) of Medical ProductsIn accordance with paragraph
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Certification for medical devices is a process that ensures a medical device meets regulatory standards and requirements for safety, efficacy, and performance before it can be marketed and used.
Manufacturers of medical devices, importers, and, in some cases, distributors are required to file certification for medical devices to regulatory authorities.
To fill out certification for medical devices, applicants must gather all required documentation, complete the certification application form provided by the regulatory body, and submit necessary test results and evidence of compliance with relevant guidelines.
The purpose of certification for medical devices is to ensure that products are safe and effective for use, protect public health, and provide assurance to consumers and regulatory authorities about the quality of medical devices.
The certification for medical devices must report information such as device specifications, intended use, safety and efficacy data, manufacturing processes, labelling, and compliance with applicable standards.
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