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Follow on Google News | SGS Informs on CU-TR and Other Regulations to Help Export Medical Devices to RussiaMedical devices destined for the Russian market must meet both national and regional regulations. This means demonstrating compliance both to Law 323 of the Russian Federation and the relevant Customs Union Technical Regulations (CU-TR).
Compulsory Requirements for Medical Devices in Russia At the present time, compulsory requirements for medical devices are included in each member country’s national legislation. In Russia, this is implemented as article 38 of law number 323 of the Russian Federation. The law includes definitions of medical devices, classifications, risk classes and methods of registration. Preparations for a new law on the Safety of Medical Devices are currently ongoing. The new law will include requirements for manufacturing, sales, marketing and use of medical devices. It will also define the responsibilities of all parties involved in their manufacture and distribution. Medical Devices Safety at the Customs Union Level At the Customs Union level, requirements for medical device quality (http://www.sgs.com/ Economic Limitations on Medical Devices Purchase In February 2015, the Russian government published Act 102. This new legislation places limitations on how the Russian state and communities may purchase foreign medical devices. These limitations are part of the country’s economic crisis recovery plan and cover about 40 different product categories, including CT and X-ray devices, ECG and blood transfusion equipment. Reference: Act 102 - Full List (PDF – in Russian) (http://government.ru/ Contact details: SGS Nina Pihlman Russian and Customs Union Certification Operations Manager SGS Finland - SGS Inspection Services Oy Sarkiniementie 3 (P.O.Box 128) FI-00210 Helsinki, Finland Website: www.sgs.com/ SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world. End
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