14 January 2013 |
On 01.01.2013 entered into force the Government Decree of December 27, 2012 N 1416 on the approval of rules of state registration of medical devices. Previously existing administrative regulations of Roszdravnadzor, approved by Ministry of Health of October 30, 2006 N 735, expired. Under the new rules, the medical devices registration certificates valid for an indefinite term, issued before the date of the entrance into the force of the above mentioned resolution, remain valid, but must be replaced before
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31 October 2012 |
On 14.08.2012 entered into force the order of the Russian Ministry of Health no. 7n of 15/06/2012, which introduced a new procedure for the import of samples of a medical device for the purpose of its registration with the Ministry of Health. The ministerial order has introduced a special permit for the importation of samples of a medical device, issued by the Federal Service on Surveillance in Healthcare (Roszdravnadzor). It is valid for 6 months and is expendable once.
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25 June 2012 |
From June 1, 2012 in connection with the entry into force of the Order № 76 of 21.02.2012 of the Ministry of Industry and Trade of the Russian Federation, the procedure of the registration of Declarations of Conformity has been changed. The new rules apply only to the declarations of conformity to Technical regulations of the Russian Federation and the Customs Union. In addition, the procedure of forming and maintaining of a single register of
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14 May 2012 |
In the occasion the international exhibition and conference for electric automation exhibition to be held from May 22 to 24 in Parma (Italy), Rustandard is pleased to invite all those who wish to know more about the certification of the CIS countries to stand at 019, Hall 2. On 24 May at 10.30 am in Room 300 of (in front of Hall 2) is provided for the direct intervention of the responsible of Rustandard Italy with a report on certification and
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18 April 2012 |
The burners, hot air generators and almost all gas appliances, liquid fuel or a mixture usually belong to a category of products that may pose a potential source of risk to their user safety and location of their installation. Consequently, for these devices in the Russian Federation the compulsory certification is required. At the date of publication of this article in Russia have been approved and came into force two legal documents that establish minimum requirements for this type of equipment. This is the Technical regulation No. 753 of 15/09/2009
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