RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 23, 2015 No. 55

About complex of the preliminary technical works preceding state registration of medical products

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. Approve:

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, to modification of the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus (is attached).

2. This resolution becomes effective after its official publication.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015 No. 55

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 medical equipment which are earlier registered in the Republic of Belarus

1. This Instruction determines procedure for carrying out by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further, unless otherwise specified, – the Company) complex of the preliminary technical works connected with conducting primary and specialized examinations of documents, inspections of production of products of medical appointment and medical equipment (further, unless otherwise specified, – inspection), the sanitary and hygienic, technical and clinical testing, clinical assessment and other researches 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 medical equipment which are earlier registered in the Republic of Belarus (further – preliminary technical works).

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.

Action of this Instruction taking into account the features provided by Items 98-100 of 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, extends to complex of preliminary technical works concerning the products of medical appointment and medical equipment made (imported) by residents of the Chinese-Belarusian industrial park "Great Stone" (further – residents of the industrial park) in the presence of the statement of public institution "Administration of the Chinese-Belarusian industrial park "Great Stone".

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 product circulation 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 medical application in the conditions of emergence of emergency situation or diagnosis of new, natural and focal or especially dangerous infectious diseases as foreign free aid (further if other is not determined – products of medical appointment and the medical equipment delivered in limited quantity).

3. In this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care" and Regulations on state registration (re-registration) of products of medical appointment and medical equipment are used.

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:

check of completeness and correctness of their registration;

check of completeness and relevance of information specified in them;

refining of the list and name of products of medical appointment and medical equipment according to nomenclature classification of products of medical appointment and medical equipment by types and by classes depending on potential risk of their application.

Conducting primary examination of documents is performed based on the agreement signed between the Company and the applicant. The term of conducting primary examination of documents shall not exceed 15 calendar days, and for the applicant – the resident of the industrial park when carrying out the preliminary technical works specified in subitem 6 part one. 1, subitem 6 parts one. 2, subitem 6 parts one. 3, subitem 6 parts one. 4, subitem 6 parts one. 5, subitems 6.6 and 6.7 of Item 6, parts one of subitem 7.4 of Item 7, subitems 8.8-8.11 of Item 8 of this Instruction, – shall not exceed 3 calendar days from the date of payment under the agreement of primary examination of documents.

If by results of primary examination of documents there are notes, the Company in writing notifies the applicant on need of their elimination in time, not exceeding 45 calendar days from the date of the notification, and the applicant – the resident of the industrial park – in time, not exceeding 5 calendar days from the date of the notification. After elimination by the applicant of notes primary expertize of documents is carried out repeatedly. The term of conducting repeated primary examination shall not exceed 10 calendar days, and for the applicant – the resident of the industrial park – 2 calendar days. In case of not elimination of notes in time, specified in the notification, the result of primary examination of documents is recognized negative.

In case of positive result of primary examination of the documents, except as specified, specified in part three of Item 5 of this Instruction, the Company determines preliminary technical works which carrying out is necessary for confirmation of safety, efficiency and product quality of medical appointment and medical equipment what the Company in writing informs the applicant on.

The negative result of primary examination of documents is reflected the Company in the conclusion about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and quality in form according to appendix 2 (further – the conclusion).

5. Preliminary technical works are performed based on the agreement signed between the Company and the applicant, and the term of their carrying out shall not exceed 150 calendar days from the date of its conclusion, except as specified, this Item specified in parts two and third, part one of Item 5-1 of this Instruction.

By agreement of the parties agreements the term of carrying out preliminary technical works can be prolonged up to 300 calendar days, except for the case specified in part two of Item 5-1 of this Instruction.

Based on the agreement signed between the Company and the applicant whose effective period shall not exceed 70 calendar days except for of the case specified in part three of Item 5-1 of this Instruction the preliminary technical works (including primary examination of documents) preceding entering of the following changes into the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus in case of are carried out:

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) principle of action – for product of medical appointment and medical equipment of foreign production;

reorganization and (or) change of the name of the legal entity – the producer of product of medical appointment and medical equipment (further – the producer);

modification of marking and (or) packaging of product of medical appointment and medical equipment.

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 or state members of the European Union;

the products of medical appointment and medical equipment delivered in limited quantity.

5-1. Preliminary technical works are performed based on the agreement signed between the Company and the applicant – the resident of the industrial park, and the term of their carrying out shall not exceed 30 calendar days from the date of payment under the agreement of primary examination of the documents, except as specified, specified in part three of this Item.

In the presence of notes by results of primary examination of documents the term of carrying out complex of the preliminary technical works specified in subitem 6 part one. 1, subitem 6 parts one. 2, subitem 6 parts one. 3, subitem 6 parts one. 4, subitem 6 parts one. 5, subitems 6.6 and 6.7 of Item 6, of part one of subitem 7.4 of Item 7, subitems 8.8-8.11 of Item 8 of this Instruction, it is prolonged for 30 calendar days from the date of obtaining from the applicant – the resident of the industrial park of information on elimination of notes and (or) submission of necessary information (materials).

Based on the agreement signed between the Company and the applicant – the resident of the industrial park which effective period shall not exceed 15 calendar days from the date of payment under the agreement of primary examination of documents to the Company carries out the preliminary technical works (including primary examination of documents) preceding entering of the following changes into the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus in case of:

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