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 prescription and medical equipment

Based on Item 7 of the Regulations on state registration (re-registration) of products of the medical prescription 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 prescription 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 prescription, 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 prescription 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 prescription and medical equipment to safety requirements, efficiency and quality;

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

1.1.3. the protocols and (or) acts of technical testing of products of medical prescription, medical equipment issued by accredited laboratories (centers) shall be approved by the head of the organization which was carrying out testing, or person authorized by it, are signed by contractors and to contain:

name and address of laboratory (center);

place of implementation of laboratory activities;

number of the protocol, numbering of pages;

name and contact information of the applicant;

designation and the name of technical regulatory legal acts, on compliance to which were carried out testing;

designation and the name of documents on test methods;

the description of products of medical prescription, medical equipment providing unambiguous identification and if necessary sample condition (the complete and exact name of products of medical prescription, medical equipment which were put on trials, and the name of their producer);

the date of receipt of sample (samples) for testing and date of selection of sample (samples);

date (dates) of implementation of laboratory activities;

results where it is applicable, with units of measure;

date of issue of the protocol;

recommendations (when applicable) of opportunity or impossibility of distribution of the received results of testing for other same products of medical prescription, medical equipment;

reasonable conclusion about compliance (discrepancy) of products of medical prescription, medical equipment to requirements of technical regulatory legal acts;

1.1.4. the protocols and (or) acts of sanitary and hygienic testing of products of medical prescription, medical equipment issued by accredited laboratories (centers) shall be approved by the head of the organization which was carrying out testing, or person authorized by it, are signed by contractors and to contain:

name and address of laboratory (center);

place of implementation of laboratory activities;

number of the protocol, numbering of pages;

name and contact information of the applicant;

designation and the name of technical regulatory legal acts, on compliance to which were carried out testing;

designation and the name of documents on test methods;

the description of products of medical prescription, medical equipment providing unambiguous identification and if necessary sample condition (the complete and exact name of products of medical prescription, medical equipment which were put on trials, and the name of their producer);

the date of receipt of sample (samples) for testing and date of selection of sample (samples);

date (dates) of implementation of laboratory activities;

results where it is applicable, with units of measure;

date of issue of the protocol;

recommendations (when applicable) of opportunity or impossibility of distribution of the received results of testing for other same products of medical prescription, medical equipment;

reasonable conclusion about compliance (discrepancy) of products of medical prescription, medical equipment to requirements of technical regulatory legal acts;

recommendations of opportunity or impossibility of state registration (re-registration);

1.1.5. the protocols and (or) acts of clinical testing of products of medical prescription, medical equipment issued by the state organizations of health care shall be approved by the head of the organization which was carrying out testing, and during absence of the head – are drawn up by person fulfilling its duties on the letterhead, signed by all members of the commission who were carrying out testing and to contain:

basis for carrying out testing;

start dates and completion of testing;

purpose and tasks of testing;

specifying of the program and technique of medical testing according to which they were carried out;

the list of products of medical prescription and medical equipment which were put on trials, with indication of their producer;

recommendations (when applicable) of opportunity or impossibility of distribution of the received results of testing for other same products of medical prescription and (or) medical equipment;

valid conclusion about compliance (discrepancy) of products of medical prescription and (or) medical equipment to requirements of the program and technique of medical testing and their efficiency;

recommendations of opportunity or impossibility of state registration (re-registration) and use in medical practice;

1.1.6. the application instruction of product of medical prescription or the operation manual on medical equipment shall be certified by the producer of product of medical prescription, medical equipment and contain the data urgent for date of filing of application about state registration (re-registration) of product of medical prescription, medical equipment, including technical characteristics.

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