of September 2, 2008 No. 1269
About state registration (re-registration) of products of medical appointment and medical equipment
Based on parts two and third article 39-1 of the Law of the Republic of Belarus of June 18, 1993 "About health care" the Council of Ministers of the Republic of Belarus DECIDES: No. 2435-XII
1. Approve Regulations on state registration (re-registration) of products of medical appointment and medical equipment it (is applied).
2. Ceased to be valid.
3. Recognize invalid:
the resolution of Council of Ministers of the Republic of Belarus of June 20, 2000 No. 921 "About approval of the Regulations on state registration of medicines and pharmaceutical substances and Regulations on state registration of products of medical appointment and medical equipment" (The national register of legal acts of the Republic of Belarus, 2000, No. 64, 5/3514);
the resolution of Council of Ministers of the Republic of Belarus of October 11, 2001 No. 1476 "About modification and amendments in resolutions of Council of Ministers of the Republic of Belarus of December 7, 1998 No. 1870 and of June 20, 2000 No. 921" (The national register of legal acts of the Republic of Belarus, 2001, No. 100, 5/9224);
subitem 1.34 of Item 1 of the resolution of Council of Ministers of the Republic of Belarus of August 2, 2006 No. 990 "About modification and amendments in some orders of the Government of the Republic of Belarus and recognition voided the separate orders of the Government of the Republic of Belarus in connection with reorganization of system of republican state bodies" (The national register of legal acts of the Republic of Belarus, 2006, No. 146, 5/22839).
4. To the Ministry of Health in three-months time to bring the regulatory legal acts into accord with this resolution and to take other measures for its realization.
5. This resolution becomes effective since September 1, 2008.
First Deputy Prime Minister of the Republic of Belarus
V. Semashko
Approved by the Resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269
Voided according to the Resolution of Council of Ministers of the Republic of Belarus of 01.04.2015 No. 254
Approved by the Resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269
1. This Provision determines procedure for state registration (re-registration) for products of medical appointment and medical equipment in the Republic of Belarus. Requirements of this provision are obligatory for the legal entities and individual entrepreneurs performing production (production), import, realization and medical application (operation) of products of medical appointment and medical equipment.
2. For the purposes of this provision terms and their determinations in the values established by the Law of the Republic of Belarus "About health care" and also the following terms and their determinations are used:
safety of products of medical appointment and medical equipment – the positive product characteristic of medical appointment and medical equipment based on risk assessment of possible damnification of life, to health of the person and the environment;
state registration of products of medical appointment and medical equipment – the procedure of the admission to production (production), realization and medical application (operation) of the products of medical appointment and the medical equipment made (made) in the Republic of Belarus or arriving because of its limits which are acknowledged conforming to the requirements for safety, efficiency and quality for the person established in the Republic of Belarus;
The state register of products of medical appointment and medical equipment of the Republic of Belarus (further – the State register) – the state information resource containing data on products of medical appointment and medical equipment concerning which state registration (re-registration), and also data on the changes made to the registration file on products of medical appointment and medical equipment is performed;
product quality of medical appointment and medical equipment – set of the properties and product characteristics of medical appointment and medical equipment influencing their capability to be effective to destination on condition of compliance to requirements of technical regulatory legal acts in the field of technical regulation and standardization;
the producer of products of medical appointment and medical equipment (further – the producer) – the legal entity or the individual entrepreneur responsible for the development and production (production) of products of medical appointment and medical equipment making them available for use on its own behalf irrespective of are developed and made products of medical appointment and medical equipment by this person or from his name other legal entity or the individual entrepreneur, and the bearing responsibility for their safety, efficiency and quality (are made);
the production site – the location of the production and auxiliary rooms of the legal entity or individual entrepreneur intended for accomplishment of production process (production) of products of medical appointment, medical equipment and (or) its certain stages;
the registration file – the set of documents created when 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, and containing the data confirming safety, efficiency and product quality of medical appointment and medical equipment including results of inspection of their production on compliance to the requirements established by the Ministry of Health;
the registration certificate – the document issued by results of state registration (re-registration) and confirming permission of the Ministry of Health to production (production), realization and medical application (operation) of products of medical appointment and medical equipment in the Republic of Belarus during certain term;
registration number – the specification symbol appropriated to product of medical appointment and medical equipment in case of state registration;
emergency situation – the situation caused by absence or threat of lack of products of medical appointment and the medical equipment necessary for delivery of health care for the population of the Republic of Belarus as a result of industrial accident, other dangerous situation of technogenic nature, catastrophic crash, natural hazard, natural or other disaster, epidemics, mass noninfectious diseases which entailed or can entail the human victims, damnification to human health or the environment, significant material damage and violation of conditions of life activity of people;
efficiency of products of medical appointment and medical equipment – set of the characteristics providing achievement of preventive, diagnostic, medical and (or) rehabilitation effect.
3. Implementation of 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 are preceded by complex of the preliminary technical works connected with carrying out:
primary examination of documents;
inspections of production of products of medical appointment and medical equipment;
researches (testing) for the purpose of assessment of biological effect of products of medical appointment and medical equipment of national and foreign production;
technical testing of products of medical appointment and medical equipment of national production;
specialized examination of documents;
the clinical testing of products of medical appointment and medical equipment appointed by the Ministry of Health;
clinical assessment on the basis of clinical data and the proof of equivalence of the medical equipment which is earlier registered in the Republic of Belarus (for the large-size equipment requiring supply of communications, construction and (or) installation works);
other researches.
The complex of preliminary technical works provided in part one of this Item is performed by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further – RUP "The Center of Examinations and Testing in Health Care") in the cases and procedure determined by the Ministry of Health.
RUP "The Center of Examinations and Testing in Health Care" are provided according to the procedure, established by the legislation, record keeping and the document storage connected with 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.
3-1. For the solution of questions of 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, feasibility of reference of products to products of medical appointment and medical equipment as the Ministry of Health the commission on products of medical appointment and medical equipment is created.
The regulations on the commission on products of medical appointment and medical equipment affirm the Ministry of Health.
4. Products of medical appointment and medical equipment are subject to state registration:
for the first time created in the Republic of Belarus and offered for medical application (operation) in the Republic of Belarus;
made (made) in other countries and for the first time offered for medical application (operation) in the Republic of Belarus;
similar registered, but made (made) by other producer;
the products of medical appointment and medical equipment registered earlier in case of addition of the new production site;
being the part (picking) of other products of medical appointment and medical equipment but applied (operated) realized separately;
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 (operation) in the conditions of emergence of emergency situation or for diagnosis of new, natural and focal or especially dangerous infectious diseases;
as foreign free aid.
5. Are not subject to state registration:
the products of medical appointment which were in the use and (or) recovered and medical equipment;
products of medical appointment and the medical equipment imported into the Republic of Belarus or made (made) in the Republic of Belarus, including by orders and the technical and (or) other documentation of foreign legal entities regulating production (production) and quality control of products of medical appointment and medical equipment, and intended for realization outside the Republic of Belarus;
the component parts which are components of the registered products of medical appointment and medical equipment;
the raw materials, materials and component parts intended for production (production) of products of medical appointment and medical equipment in the Republic of Belarus (according to the specifications and technical documentation of the producer);
the spare parts intended for repair of products of medical appointment and medical equipment;
products of medical appointment and medical equipment on which permission of the Ministry of Health to realization and (or) medical application (operation) of the unregistered products of medical appointment and medical equipment is in accordance with the established procedure issued;
products of medical appointment and the medical equipment imported on the territory of the Republic of Belarus by physical person for personal application.
6. Can be the applicant:
6.1. for the state registration (re-registration) of products of medical appointment and medical equipment specified in paragraphs by second or pole of item 4 of this provision, modification of the registration file on the specified products of medical appointment and the medical equipment which is earlier registered in the Republic of Belarus, issues of the duplicate of the registration certificate on these medical products:
the legal entity (individual entrepreneur) making (making) product of medical appointment and medical equipment, including the placed order for the production (production) of products of medical appointment and medical equipment or which 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 making (making) medicines, the placed order for production (production) and (or) acquisition of products of medical purpose of foreign production, held for use in production (production) of medicines if these products of medical appointment are not registered in the Republic of Belarus by the foreign producer;
6.2. for the state registration of products of medical appointment and medical equipment specified in paragraphs the seventh or tenth item 4 of this provision, issue of the duplicate of the registration certificate these medical products - the legal entity (individual entrepreneur) participating in the address of limited quantity of products of medical appointment and medical equipment.
7. The applicant after passing of complex of preliminary technical works in the presence of the positive conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and the quality containing results of examinations, inspections of testing and other researches provided in Item part one 3 this provision submits the following documents and (or) data necessary for carrying out to the Ministry of Health:
7.1. the state registration (re-registration) of products of medical appointment and medical equipment except for specified in paragraph one of subitem 7.2 of this Item:
statement;
conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and qualities;
7.2. state registration and issue of the registration certificate on 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, medical application in the conditions of emergence of emergency situation or for diagnosis of new, natural and focal or especially dangerous infectious diseases, arriving as foreign free aid:
statement;
conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and qualities;
the agreement (contract) for delivery to the Republic of Belarus of products of medical appointment and medical equipment, the specification to it, the agreement (contract) for delivery of medical products signed with the organization of health care or the organizer of public procurement.
8. Excluded
9. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
10. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
11. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
12. By results of consideration of the documents provided by the applicant according to Item 7 of this provision by the Ministry of Health one of the following decisions is accepted:
about refusal in adoption of the statement;
about refusal in state registration (re-registration) of products of medical appointment and medical equipment;
about state registration (re-registration) of products of medical appointment and medical equipment.
The made decision is drawn up by the order of the Ministry of Health.
13. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
14. The Ministry of Health no later than 5 working days in writing informs the applicant on the made decision and on need of payment by the applicant of the established state fee.
15. After obtaining from the Ministry of Health of written information on state registration (re-registration) of products of medical appointment and medical equipment the applicant pays the state fee provided according to the legislation for state registration (re-registration) of products of medical appointment and medical equipment.
16. To the applicant by results of state registration (re-registration) of products of medical appointment and medical equipment within five working days from the date of confirmation of the actual payment by him in the republican budget of the state fee the Ministry of Health issues the registration certificate in form according to appendix. The form of the registration certificate is the form with certain degree of protection.
By results of implementation of state registration (re-registration) of product of medical appointment and medical equipment the termless registration certificate is issued.
Data on the registered products of medical appointment and medical equipment join RUP "The Center of Examinations and Testing in Health Care" in the State register during the term specified in part one of this Item.
17. In case of carrying out state registration (re-registration) products of medical appointment and medical equipment:
made (made) by one producer, but on different production sites, the registration certificate is issued on products of medical appointment and medical equipment on each production site;
when implementing on the production site of certain production stages (production) of products of medical appointment and medical equipment in one registration certificate production sites of all production stages (production) of products of medical appointment and the medical equipment made (made) by one producer are specified.
Inclusion in one registration certificate of several product modifications of medical appointment and medical equipment relating to one type according to the nomenclature classification of medical products applied in the Republic of Belarus is possible on condition of compliance of these modifications to at the same time following criteria:
production (production) of modifications of medical product is performed by one producer of medical product according to one technical documentation;
modifications of medical product belong to one class of potential risk of application;
modifications of medical product have the different pickings which are not influencing the principle of work and functional purpose that allows to provide expansion or specialization of their medical application (operation);
modifications of medical product have the different technical parameters (for example, the radiation wavelength, the size of the light field, resolution and so forth) which are not influencing the principle of work and functional purpose (on applicability);
modifications of medical product form tiporazmerny row (for example, have the different sizes (dimensional, linear, volume and so forth), form, color coding and so forth) or are group of execution of medical product (for example, the stationary portable device (the device, system, complex and to that similar) with wall and (or) floor fixture and to that similar) (on applicability). At the same time the group of execution of medical product is understood as products concerning which one group drawing of details and (or) one group specification are executed.
18. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
19. The state re-registration of products of medical appointment and medical equipment is performed:
in case of expiration of the registration certificate, except for the products of medical appointment and medical equipment imported into the Republic of Belarus or made (made) in the Republic of Belarus during action of the registration certificate;
at the initiative of the applicant, but not earlier than one year from the date of state registration.
20. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
21. State registration (re-registration) of products of medical appointment and medical equipment is performed in the terms provided in subitems 9.3. 1, 9.3. 2, 9.3.5 and 9.3.6 Items 9.3 of the single list of the ministerial procedures performed concerning subjects of the managing approved by the resolution of Council of Ministers of the Republic of Belarus of September 24, 2021 No. 548 (further – the single list).
22. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
23. In case of the state re-registration of product of medical appointment and medical equipment in the new registration certificate former registration number and date (year, month) of the state re-registration are specified.
23-1. No. 175 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 25.03.2022
24. The Ministry of Health refuses state registration (re-registration) of products of medical appointment and medical equipment in the cases provided by the Law of the Republic of Belarus of October 28, 2008 No. 433-Z "About bases of ministerial procedures" and also in cases:
carrying out state registration (re-registration) by other applicant of product of medical appointment and the medical equipment included in the State register under the same trade name;
non-presentations by the applicant during state registration (re-registration) the documents and (or) data specified in Item 7 of this provision.
25. The Item is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 19.05.2020 No. 298
26. The Ministry of Health can make the decision on suspension of action of the issued registration certificate or separate registration numbers of products of medical appointment, medical equipment on product of medical appointment and medical equipment if:
as a result of medical application (operation) of product of medical appointment and (or) medical equipment there was unfavorable event (incident) and the circumstances which entailed its approach are not eliminated;
established fact of preventing by the producer to evaluating production process (production) products of medical appointment and the medical equipment appointed by the Ministry of Health;
negative results of researches (testing) for the purpose of assessment of biological effect, technical and clinical testing are received;
the applicant for state registration (re-registration) provided the registration file containing false information which was not and could not be established in case of state registration (re-registration);
it is suspended or cancelled the certificate of conformity because of discrepancy to requirements of technical regulatory legal acts in the field of technical regulation and standardization on product of medical appointment and medical equipment or the document resolving production (production), realization and medical application (operation) of product of medical appointment and medical equipment;
the applicant does not submit the data specified in Item 30 of this provision in time;
not message established fact the producer (his authorized representative) in accordance with the established procedure RUP "The Center of Examinations and Testing in Health Care" about unfavorable event (incident) connected with medical application (operation) of product of medical appointment and (or) medical equipment, or violation of the terms established for such message.
27. The decision on suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment with indication of the reasons of such suspension, date with which it is suspended the registration certificate or separate registration numbers of products of medical appointment, the medical equipment established proceeding from the possible predicted effects of medical application (operation) of these products of medical appointment and medical equipment, and term of suspension is accepted in the form of the order of the Ministry of Health.
The term of suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment cannot be more than six months.
For the period of suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment the term of its action is not prolonged, except as specified, when the judgment acknowledged illegal suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment.
The Ministry of Health notifies the applicant no later than 5 days before date with which effective period of the registration certificate or separate registration numbers of products of medical appointment, medical equipment with indication of the reason and the term of its suspension stops on suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment.
The applicant during the term for which it is suspended the registration certificate or separate registration numbers of products of medical appointment, medical equipment shall eliminate the circumstances which entailed suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment and in writing to notify on it the Ministry of Health, having attached written proofs.
28. By results of consideration of written proofs by the Ministry of Health the decision on renewal of action or on cancellation of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment with indication of date of its renewal or cancellation is made.
Within 3 days from the date of adoption of such decision the Ministry of Health in writing reports about renewal of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment to the applicant.
The decision on renewal of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment is accepted in the form of the order of the Ministry of Health and becomes effective from the date of its acceptance.
29. In case of not elimination by the applicant of the circumstances which entailed suspension of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment, the Ministry of Health makes the decision on cancellation of the registration certificate or separate registration numbers of products of medical appointment, medical equipment with indication of the cancellation reasons.
The decision is made in the form of the order of the Ministry of Health.
The Ministry of Health notifies the applicant no later than 3 days before date with which action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment, with indication of the reason of its cancellation is cancelled on cancellation of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment.
RUP "The Center of Examinations and Testing in Health Care" after the introduction of the decision on cancellation of action of the registration certificate or separate registration numbers of products of medical appointment, medical equipment in force excludes data on these products of medical appointment and medical equipment from the State register.
30. The applicant shall provide in the Ministry of Health information not later than after receipt of the following data by it in a month:
about change of the address of the production site;
about loss by medical product of the status of medical product in connection with modification of regulatory legal acts and (or) technical regulatory legal acts;
about voluntary response the producer of medical product from the address.
30-1. Modification of the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus it is performed in cases:
changes 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);
introduction of the new medical indication;
reorganization and (or) changes of the name of the legal entity – the producer of product of medical appointment and medical equipment, including change of the location;
changes of the production site of product of medical appointment and medical equipment;
modification of technical regulatory legal acts (except for the changes concerning development of new type (modification) of product of medical appointment and medical equipment) – for product of medical appointment and medical equipment of national production;
additions (exception) of accessories to products of medical appointment and (or) medical equipment or changes of their name;
modification of marking and (or) packaging of product of medical appointment and medical equipment;
changes of expiration dates (operation) and (or) storage conditions of product of medical appointment and medical equipment;
changes of class of potential risk of product of medical appointment and medical equipment;
modification of the instruction for application of product of medical appointment or operation manual on medical equipment;
modification of size range of products of medical appointment and (or) the medical equipment which is 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.
31. Applicants in case of need modification of the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus within three months from the date of approval of the country of the producer by authorized body or if this approval is not required, – from the date of adoption by the applicant of the decision on modification of the registration file after passing of complex of preliminary technical works in the presence of the positive conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and the quality containing results of examinations, inspections, testing and other researches provided in Item part one 3 this provision submit in the Ministry of Health the application and the conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical appointment and medical equipment to safety requirements, efficiency and qualities with indication of the reasons of introduction of the specified changes. Requirements to supplied to documents and (or) to the information are determined by the Ministry of Health.
32. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
33. No. 768 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 07.08.2014
34. By results of consideration of 31 this provision of documents provided by the applicant according to Item by the Ministry of Health one of the following decisions is accepted:
about refusal in adoption of the statement;
about refusal in modification of the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus;
about modification of the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus.
The made decision is drawn up by the order of the Ministry of Health.
35. The Ministry of Health in writing informs the applicant on the made decision no later than 5 working days from the date of its acceptance.
36. Modification of the registration file of the registered products of medical appointment and medical equipment is performed in the terms provided by subitems 9.3.3 and 9.3.7 of Item 9.3 of the single list.
36-1. If the changes made to the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus at the same time attract change of information containing in the registration certificate, then the Ministry of Health according to Item 1 of article 28-1 of the Law of the Republic of Belarus "About bases of ministerial procedures" issues the new registration certificate on effective period of the registration certificate issued in case of state registration (re-registration) of this product of medical appointment and this medical equipment.
36-2. RUP "The Center of Examinations and Testing in Health Care" based on the decision of the Ministry of Health on modification of the registration file on the products of medical appointment and medical equipment which are earlier registered in the Republic of Belarus includes data on the entered changes in the State register.
37. During suspension of action of the registration certificate modification of the registration file is not made, except as specified, when necessary for elimination of the reasons which entailed suspension of action of the registration certificate.
38. The state register is created by the Ministry of Health based on RUP "The Center of Examinations and Testing in Health Care".
39. RUP "The Center of Examinations and Testing in Health Care" are performed development and upgrade of the State register, technical and the software of its maintaining, including the automated combination of the data included in the State register, their updating, storage and protection, and also other powers on maintaining the State register.
40. The state register is the state information resource, is kept in the form of the electronic database protected from damage and unauthorized access by means of the specialized software.
41. Maintaining the State register is performed by inclusion in it of data on products of medical appointment and medical equipment concerning which state registration (re-registration), and also data on the changes made to the registration file on products of medical appointment and medical equipment is performed.
42. The State register joins data:
about the name of products of medical appointment and medical equipment (the number or serial number, either batch number (lot), or date of production (production) – for the products of medical appointment and medical equipment specified in paragraphs the seventh or tenth item 4 of this provision);
about type of product of medical appointment and medical equipment;
about code of product of medical appointment and medical equipment according to listed products of medical appointment and medical equipment;
about the name of the applicant;
about the name of the producer of product of medical appointment and medical equipment;
about the address of the producer of product of medical appointment and medical equipment;
about the name of the production site of product of medical appointment and medical equipment;
about the address of the production site of product of medical appointment and medical equipment;
about the specifications and technical documentation on products of medical appointment and medical equipment;
about structure of product of medical appointment and medical equipment;
about number of state registration of product of medical appointment and medical equipment;
about number of the registration certificate;
about date of state registration of product of medical appointment and medical equipment;
about effective period of the registration certificate;
about the status of action of the registration certificate;
about date of cancellation of the registration certificate;
about area of medical application (operation) and (or) restriction of the specified application of product of medical appointment and medical equipment, and also other information;
about availability of the instruction for application of product of medical appointment or the operation manual on medical equipment.
43. The state register is posted on the official sites of the Ministry of Health and RUP "The Center of Examinations and Testing in Health Care" on the global computer Internet.
44. Maintaining the State register is performed for the purpose of informing consumers, producers and product providers of medical appointment and medical equipment, bodies and the organizations of system of the Ministry of Health for accomplishment of functions by them, stipulated by the legislation, and also for implementation customs, tax, transport and other types of the state control.
45. The data containing in the State register are open and publicly available.
to Regulations on state registration (re-registration) of products of medical appointment and medical equipment
Form
MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS
Registration certificate No.
This certificate is issued _________________________________________
_____________________________________________________________________________
(name of the applicant, country)
is also confirmation of the fact that are registered by the Ministry of Health of the Republic of Belarus _____________________________________________________
(type according to nomenclature
_____________________________________________________________________________
classification, name of product of medical appointment (medical equipment),
_____________________________________________________________________________
type, type, model, size of product of medical appointment (medical equipment),
_____________________________________________________________________________
name of the producer, country of the producer, address of production (production),
_____________________________________________________________________________
name of the production site, country of the production site,
_____________________________________________________________________________
address of the production site)
also are permitted to production (production), realization and medical application (operation) in the territory of the Republic of Belarus ________________________________
(area of medical application (operation),
____________________________________________________________________________
restrictions of the specified application)
Registration number ________________________________________________________
The registration certificate is not the obligation to purchase of this product of medical appointment (medical equipment).
|
Date of state registration |
Really to | |
|
__ _____________ 20 __. |
__ ______________ 20 __. |
|
Minister (deputy minister) of health care |
|||
|
Republic of Belarus |
___________ |
______________________________ | |
|
(signature) |
(initials, surname) | ||
|
M.P. |
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