{"id":4158,"date":"2019-09-17T09:10:03","date_gmt":"2019-09-17T09:10:03","guid":{"rendered":"https:\/\/improvemed.com.ua\/?page_id=4158"},"modified":"2023-08-17T04:15:38","modified_gmt":"2023-08-17T04:15:38","slug":"ocenka-sootvetstija-med-izdeliy","status":"publish","type":"page","link":"https:\/\/improvemed.com.ua\/en\/ocenka-sootvetstija-med-izdeliy\/","title":{"rendered":"ASSESSMENT OF COMPLIANCE WITH TECHNICAL REGULATIONS"},"content":{"rendered":"

IMPROVE MEDICAL LLC is an authorized body for conformity assessment with the Technical Regulations for Medical Devices.<\/strong><\/p>\n

The identification number UA.TR.120<\/strong> was assigned.<\/p>\n

Corresponding Orders No. \u2116 1898,<\/a> \u21161899<\/a>, 1900<\/a> of the Ministry of Economic Development of Ukraine dated 11.11.2016<\/p>\n

Decisions \u21161898<\/a>, \u21161899<\/a>, \u21161900<\/a> of the Ministry of Economic Development of Ukraine<\/p>\n

The authority of the company extends to assessing the conformity of products with the following Technical Regulations:
\nN 753 “On Approval of the Technical Regulations for Medical Devices”
\n<\/em><\/a>N 754 “On Approval of the Technical Regulations for Medical Devices for In Vitro Diagnostics”
\n<\/em><\/a>N 755 “On approval of the Technical Regulations on active medical devices that are implanted”<\/a><\/em><\/p>\n

To receive the Cost of work <\/span> on the Conformity Assessment with the Technical Regulations of Medical Devices, you need to provide the required list of documents, as well as completed forms. See links below.<\/strong><\/p>\n

Required list of documents from the manufacturer of medical devices.<\/a><\/strong><\/p>\n

Application for Conformity Assessment of TR for Medical Devices<\/a><\/strong>
\nApplication for a design review of a medical device (TR 753)<\/a><\/strong>
\nApplication for verification of the design of a medical device for in vitro diagnostics (TR 754)<\/a><\/strong>
\nApplication for design verification of an active medical device that is implantable (TR 755)<\/a><\/strong><\/p>\n

Send the completed forms and the required list of documents to us at improvemedua@gmail.com<\/a>.<\/p>\n

Our experts will need only one day to prepare a solution and calculate the work.
\nIf you have any questions regarding the choice of the Conformity Assessment procedure and filling out the forms, please call us at +38 044 355 50 30. Improve Medical experts will always be happy to inform you about the application of Ukrainian legislation in the field of technical regulation.<\/p>\n

Determine the class of the medical device<\/a><\/strong><\/h4>\n

<\/p>","protected":false},"excerpt":{"rendered":"

IMPROVE MEDICAL LLC is an authorized body for conformity assessment with the Technical Regulations for Medical Devices. The identification number UA.TR.120…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-template.php","meta":{"footnotes":""},"class_list":["post-4158","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/pages\/4158","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/comments?post=4158"}],"version-history":[{"count":0,"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/pages\/4158\/revisions"}],"wp:attachment":[{"href":"https:\/\/improvemed.com.ua\/en\/wp-json\/wp\/v2\/media?parent=4158"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}