In November 2017, the EAEU Council approved requirements for implementation, maintenance, and evaluation of the quality management system for medical devices with regards to the potential risk of their use. These measures were implemented to ensure that products sold in the EAEU have stable quality and safety performance.
However, the requirements became mandatory from March 16, 2019. It means that now manufacturers of medical devices must implement the Quality Management System on their factories. The supervisory audit is also mandatory for the medical devices which use is associated with a high risk to the patient's well-being.
Moreover, for the EAEU manufacturers as well as for the foreign manufacturers of medical devices, the Quality Management System evaluation must be carried out in the form of supervisory inspection once per every three years. Schedules for periodic inspections should be posted on the official websites of authorized bodies as well as on the EAEU information portal.
The quality management system is voluntary for such medical devices as spatulas, eye pipettes, heating pads, enemas, bandages, patches, etc., which are not associated with threat to public health and safety and the well-being of humanity. If manufacturers of these medical devices decide to carry out the audit on their factories, the amendments in the registration dossier of such devices can be done within a notification procedure in the future.
The information has been prepared by the GMA Consult Group team.
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