RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 15, 2009 No. 41

About requirements to the documents submitted for state registration (re-registration) of products of medical appointment and medical equipment

Based on Item 7 of the Regulations on state registration (re-registration) of products of the medical appointment and medical equipment approved by the resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269, of subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, the Ministry of Health of the Republic of Belarus DECIDES:

1. Determine that:

1.1. the documents submitted for state registration (re-registration) and issue of the registration certificate on products of medical appointment and medical equipment of national production shall conform to the following requirements:

1.1.1. the statement on state registration (re-registration) of product of medical appointment, medical equipment shall be constituted in form according to appendix 1.

The name specified in the statement, the list, picking (structure) of products of medical appointment and medical equipment, the name of their producer and applicant shall correspond to the data which are in prison of the republican unitary enterprise "The Center of Examinations and Testing in Health Care" about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and quality;

1.1.2. technical regulatory legal acts of the producer on products of medical appointment, medical equipment with checking technique shall be developed (for measuring instruments) according to the procedure, established by the legislation;

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