The list of information on non-original components for the repair of medical devices has been approved

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Roszdravnadzor, by Order No. 2983 of May 16, 2023, approved a list of requirements for submitting documents for the recognition of non-original spare parts suitable for repair or maintenance of medical equipment. The regulations will come into effect on September 1, 2023.

According to the order, the applicant must prepare a package of documents describing the model, the manufacturer of components, the original product, technical documentation and other data, and submit it to Roszdravnadzor.

After that, the All-Russian Research and Testing Institute of Medical Technology (VNIIIMT) conducts a study on the compatibility of components and medical equipment. Conclusions on compatibility will be published on the website.

The government allowed the use of non-original spare parts and components for the maintenance of medical equipment in January 2023.