RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of October 19, 2021 No. 110

About change of the resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015 No. 55

Based on part two of Item 3 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 8.25-1 of Item 8 and 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. Bring in the Instruction about procedure for carrying out complex of the preliminary technical works preceding state registration (re-registration) of products of medical appointment and medical equipment, modification of the registration file on the products of medical appointment and the medical equipment which are earlier registered in the Republic of Belarus, approved by the resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015 No. 55, the following changes:

add Item 1 with part of the following content:

"Action of this Instruction does not extend much carrying out:

complex of the technical works connected with conducting examinations, inspections of production of medical products, testing and other researches for implementation of registration, modification of the registration file and connected with registration of other medical products of procedures within the Eurasian Economic Union;

complex of the preliminary technical works preceding the state re-registration of the medical products made (imported) by residents of the Chinese-Belarusian industrial park "Great Stone" to modification of the registration file on the medical products made (imported) by residents of the Chinese-Belarusian industrial park "Great Stone", which are earlier registered in the Republic of Belarus, the Regulations on special legal regime of the Chinese-Belarusian industrial park "Great Stone" approved by the Presidential decree of the Republic of Belarus of May 12, 2017 No. 166 provided by Items 99 and 100.";

state Item 2 in the following edition:

"2. For the purpose of this Instruction as the applicant it is understood:

the legal entity (individual entrepreneur) who is making products of medical appointment and medical equipment, including placed the order for production of products of medical appointment and medical equipment or the legal entity (individual entrepreneur) who is part of one merging with producer of products of medical appointment and medical equipment;

the legal entity (individual entrepreneur) of the Republic of Belarus who is making medicines, placed the order for production and (or) acquisition of products of medical purpose of foreign production, held for use in industrial production of medicines if these products of medical appointment are not registered in the Republic of Belarus by the foreign producer;

the legal entity (individual entrepreneur) participating in the address of medical products when carrying out complex of the preliminary technical works preceding the state registration of products of medical appointment and medical equipment delivered in limited quantity for the state organizations of health care for the purpose of accomplishment of the international programs by them in the field of health care for the emergency needs of the state organizations of health care, including for disaster recovery, catastrophic crashes, epidemic diseases in other exceptional cases and also for treatment of the narrow contingents of patients, including patients with seldom found pathology, as foreign free aid (further if other is not determined - products of medical appointment and the medical equipment delivered in limited quantity).";

in item 4:

the paragraph one of part one to state in the following edition:

"4. Carrying out complex of preliminary technical works begins with primary examination of the documents of the registration file submitted by the applicant according to the list according to appendix 1 (further - documents) which provides:";

the fifth after the word to "appendix" to add part with figure "2";

add Item 5 with part of the following content:

"Preliminary technical works are performed in the relation:

products of medical appointment and medical equipment of national production;

products of medical appointment and medical equipment of foreign production;

products of medical purpose of foreign production, held for use in industrial production of the medicine represented on state registration by the legal entity or individual entrepreneur of the Republic of Belarus making medicines;

the products of medical appointment and medical equipment of foreign production which are in circulation in the territory of the United States of America and state members of the European Union;

the products of medical appointment and medical equipment delivered in limited quantity for the state organizations of health care for the purpose of accomplishment of the international programs by them in the field of health care;

the products of medical appointment and medical equipment delivered in limited quantity for the emergency needs of the state organizations of health care, including for disaster recovery, catastrophic crashes, epidemic diseases in other exceptional cases, and also for treatment of the narrow contingents of patients, including patients with seldom found pathology;

the products of medical appointment and medical equipment delivered in limited quantity as foreign free aid.";

in Item 6:

in subitem 6.1:

the paragraph third parts one after words of European Union to add with the words "and also the products of medical appointment and medical equipment delivered in limited quantity";

in part eleven:

to exclude the word of "(re-registration)";

add part with words ", the products of medical appointment and medical equipment delivered in limited quantity";

part the second subitem 6.2 after words of European Union to add with words of "the products of medical appointment and medical equipment delivered in limited quantity";

add subitem 6.3 with part of the following content:

"Technical testing are not carried out concerning the products of medical appointment and medical equipment delivered in limited quantity;";

in subitem 6.4:

after part one to add the subitem with part of the following content:

"Specialized examination of documents provides assessment of information containing in them on compliance to requirements of efficiency, safety and quality taking into account features of application of products of medical appointment and medical equipment in clinical practice.";

third to state part in the following edition:

"Specialized expertize of documents is carried out:

two and more experts determined by the Company from number of persons employed of the Company and in need of the experts included in structure of groups of experts of the commission on medical products, and (or) the involved specialists of the organizations of health care system within whose competence questions of specialized examination of documents are;

one expert who is the chief non-staff specialist of the Ministry of Health or the specialist of the Ministry of Health in profile, the chief non-staff specialist or the specialist of head department in health care of regional executive committee, Healthcare Committee of the Minsk city executive committee on profile - concerning the products of medical appointment and medical equipment delivered in limited quantity.";

the fifth after the word "conclusions" to add part with words of "the experts specified in the paragraph the second to part four of this subitem";

the paragraph one of part nine to state in the following edition:

"Experts when conducting specialized examination of documents, except for documents on the products of medical appointment and medical equipment of foreign production which are in circulation in the territory of the United States of America and state members of the European Union or delivered in limited quantity carrying out clinical testing on condition of availability at the same time at least two following bases can be recommended:";

add subitem 6.5 with part of the following content:

"Clinical testing of products of medical appointment and medical equipment are carried out in two and more state organizations of health care;";

in Item 7:

the paragraph one after the word "equipment" to add with words ", except for the products of medical appointment and medical equipment delivered in limited quantity";

in subitem 7.4 of the word "parts of the second or ninth of the subitem" to replace with the word "subitem";

in Item 8:

the paragraph one after the word "Belarus" to add with words ", except for the products of medical appointment and medical equipment delivered in limited quantity";

subitem 8 in paragraph three. 2, paragraph the fourth subitem 8. 3, paragraph the fourth subitem 8 part one. The paragraph the second subitems 8.5 and 8.6 of the word "parts of the second or ninth of the subitem" to replace 4, with the word "subitem";

add Item with subitems 8.7-8.11 of the following content:

"8.7. in case of modification of the instruction for application of product of medical appointment or the operation manual on medical equipment:

specialized examination of documents according to subitem 6.4 of Item 6 of this Instruction;

other preliminary technical works, stipulated in Item the 6 or 7 this Instruction if by results of specialized examination of documents it is determined that the made changes in the registration file can affect safety, efficiency and product quality of medical appointment and medical equipment;

8.8. in case of modification of size range of the products of medical appointment and (or) medical equipment which are not influencing the principle of work and functional purpose (change of parameters of length, diameter, amount, the size), in addition to the registered products of medical appointment and (or) medical equipment:

technical testing of products of medical appointment and medical equipment of national production for compliance to the requirements provided in subitem 6.3 of Item 6 of this Instruction;

specialized examination of documents according to subitem 6.4 of Item 6 of this Instruction;

other preliminary technical works, stipulated in Item the 6 or 7 this Instruction if by results of specialized examination of documents it is determined that the made changes in the registration file can affect safety, efficiency and product quality of medical appointment and medical equipment;

8.9. in case of change of the name of product of medical appointment and medical equipment without change of the properties and characteristics influencing quality, efficiency and safety of product of medical appointment and medical equipment, or enhancement of their properties and characteristics in case of invariance of functional purpose and (or) the principles of action (for product of medical appointment and medical equipment of foreign production) - primary examination of documents;

8.10. by reorganization and (or) change of the name of the legal entity (producer) - primary examination of documents;

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