ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of January 22, 2007 No. 33

About approval of the Regulations on licensing of production of medical equipment

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of production of medical equipment.

2. Recognize to invalid:

the order of the Government of the Russian Federation of August 16, 2002 N612 "About Approval of the Regulations on Licensing of Production of Medical Equipment" (The Russian Federation Code, 2002, N 34, the Art. 3301);

Item of 104 changes which are made to the resolutions of Council of Ministers of RSFSR, the Government of RSFSR and the Government of the Russian Federation concerning state registration of the legal entities approved by the order of the Government of the Russian Federation of October 3, 2002 N731 (The Russian Federation Code, 2002, N 41, by the Art. 3983).

Approved by the order of the Government of the Russian Federation of January 22, 2007 No. 33

Regulations on licensing of production of medical equipment

1. This Provision determines procedure for licensing of the production of medical equipment performed by legal entities and individual entrepreneurs including industrial production and individual production of medical equipment.

2. Licensing of production of medical equipment is performed by the Federal Service on supervision in the field of health care (further - the licensing body).

3. The license for activities on production of medical equipment is provided for 5 years. The validity of the license can be extended according to the procedure, provided for renewal of the license.

4. Licensed requirements and conditions when implementing activities for production of medical equipment are:

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