+7 495 660-30-39 multichannel About the center Services Helpful information TC 11 Feedback Contacts Home / Services / Those. terms Technical specifications (TU) are developed without fail for Russian medical products. They should contain the full scope of product, inspection and acceptance requirements. The rules for drawing up TU are contained in GOST 2.114-95. For technical tests, a draft TU is submitted, which in the process of testing can be finalized and modified. As a result of the tests, the final version of the technical specifications is approved by the developer, agreed with the TC and transferred along with the rest of the documents to Roszdravnadzor. During the production process, the developer may need to make changes to the manufactured product and, accordingly, to the specifications. In this case, he must contact an organization authorized to coordinate notifications of changes in technical specifications. CJSC NIIMT provides consultations on the design and preliminary examination of technical specifications for developers of medical devices, as well as approves the technical specifications and notifications of changes in technical specifications. For consultation, examination, approval, the developer sends a letter of guarantee and an application for work to CJSC NIIMT and draws up contractual relations with CJSC NIIMT. To conduct a consultation on the design, examination of technical specifications at CJSC NIIMT, the following must be submitted: TU draft (if available). The name of the product being developed. Manufacturer and OKPO code. The main parameters and dimensions of the product being developed. Main technical characteristics functional characteristics. Information about the materials from which the product is made. Coordinates of the representative of the developer company (prompt solution of issues on the product). To agree on the technical specifications, the following must be submitted: Draft specifications - 2 copies. The title page of the TU signed and stamped by the developer - 3 copies. A copy of the acceptance test report. To agree on notifications of changes in technical specifications, the following must be submitted: Draft notice of changes in technical specifications - 2 copies. Title page of the notice with the signature and seal of the manufacturing organization - 3 copies. Explanatory note in free form, which explains the reason for issuing the notice. Registration certificate (copy). Type test report (if necessary). Please arrange the time of your visit in advance. Testing Those. terms Consulting +7 495 660-30-39 multichannel Write a letter 2010, JSC "NIIMT" Testing Center for Medical Devices m Leninsky prospect, Ordzhonikizde 11 bldg 2B Website development - ArrowMedia