
Order No. 430 by the Ministry of Health of the Russian Federation
On certain specific features of the circulation of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device
In accordance with Article 38, part 51, of Federal Law “On the basic principles of public healthcare in the Russian Federation|”, and Article 17, Part 1, par. 2, of Federal Law “On the amendment of specific legislation of the Russian Federation related to the prevention and mitigation of emergency situations”, the Government of the Russian Federation hereby orders the following:
- To approve specific features of the circulation of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device, as set forth in the Addendum to this Order.
- This order comes into full force on the day of its official publication, and shall remain in force until January 1, 2021.
Head of the Government of the Russian Federation | |
M. Mishustin |
APPROVED by Order of the Government of the Russian Federation on 03 April, 2020, no. 430
**
SPECIFIC FEATURES OF THE CIRCULATION
of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device
- This document is applicable to the process of the circulation of medical devices intended for use in the course of military conflicts, emergencies, emergency preventive actions, prevention and treatment of conditions representing a significant public threat, as well as conditions and damage resulting from the effect of unfavourable chemical, biological and radiological factors, in accordance with the list attached hereto (hereinafter the ‘medical device’), including but not limited to the issue of the marketing authorisation of a batch (lot) of a medical device.
- The registration certificate for a batch (lot) of a medical device is therefore issued with a validity term until January 1, 2021.
- For the purpose of the marketing authorisation of a medical device, the developing entity, the manufacturer (producer) of such medical device, or authorized representative of the manufacturer (producer), or medical device importer importing it into the Russian Federation specifically for the purpose of obtaining such marketing authorisation (hereinafter the “Applicant”) provides or submits (in electronic and/or paper form) to the federal budgetary state enterprises reporting to the Federal Service for Surveillance in Healthcare (hereinafter, the “Expert Authority”), the following documents and items:
- the application for the marketing authorisation of the medical device concerned, completed in accordance with part 9 of the Rules for the Marketing authorisation of Medical Devices, as approved by Order of the Government of the Russian Federation no. 1416 (dated 27 December, 2012). “On approval of the rules for the marketing authorisation of medical devices” (hereinafter the “Registration Rules”):
- a copy of the document confirming the authority of the manufacturer’s (producer’s) authorised representative (if any);
- documents confirming the Applicant's legal ownership
- in relation to the batch (lot) of the medical device concerned;
- technical documentation of the manufacturer (producer)
- issued in relation to the medical device concerned (if any);
- operational documentation of the manufacturer (producer) for the medical device in question, drawn up in accordance with the requirements of the Ministry of Healthcare of the Russian Federation;
- photographic images of the general configuration of the medical device together with the accessories needed for its intended application (at least 18 x 24 cm);
- Supporting evidence of technical tests, toxicological studies reports for the medical device assumed to be in contact with the human body, reports from clinical trials performed in accordance with the typical trial program (depending on the type of medical device concerned) developed by the related Expert Authority (hereinafter the “Typical Program”), and published on the official web sites of the Expert Authorities on the information and communication network “Internet” (as applicable). Should the tests (trials) performed under a program other than the Typical Program, the Expert Authority has to determine whether such tests or trials are sufficient for the purpose of the marketing authorisation of the medical devices batch (lot) in accordance with this document;
- Any other documents supporting the quality, efficiency and safety of the medical device concerned (if any);
- list of documents.
If the documents mentioned above are drawn up in a foreign language, they shall be presented with a duly certified translation into Russian.
For the medical devices included in the list below, requirements set forth by the Ministry of Healthcare of the Russian Federation in relation to the conformity evaluation of medical devices in the form of technical tests, toxicological studies and clinical trials, performed within the framework of the marketing authorisation, are not considered mandatory.
This provision is in force until the complete resolution of an emergency situation threat or until the resolution of an existing emergency situation. Medical devices that do not pass this conformity evaluation shall be re-registered in accordance with the applicable legislation of the Russian Federation.
- Upon receipt of the documents mentioned in paragraph 3 of this document, the Expert Authority shall, within 3 working days, evaluate the dossier submitted for its fullness, completeness and sufficiency, including the adequacy of the scope of tests and studies (trials) performed versus the requirements of the marketing authorisation of the batch (lot) of the medical device in accordance with this document, and therefore draw an expert conclusion on the possibility of the marketing authorisation (or rejection statement, if applicable) of the batch (lot) of the medical device, as per the form approved by the Ministry of Healthcare of the Russian Federation, with the purpose of the expert evaluation of the quality, safety and efficiency of the medical device in question, and submits this conclusion/statement to the Federal Service for Surveillance in Healthcare.
Such conclusion/statement shall be accompanied with the dossier submitted as per paragraph 3 of this document.
- The rejection statement for the marketing authorisation of the batch (lot) of medical devices may be completed by the Expert Authority when one or several of the following conditions occur:
- there is no evidence of compliance of the medical device concerned with the requirements set forth in the manufacturer’s (producer's) documentation;
- there is lack of evidence of the safety of the medical device;
- the quality and/or safety and/or efficiency of the medical device concerned is not supported by the data submitted;
- the risk of damage to the health of patients and medical practitioners associated with the use of the medical device concerned outweighs related benefits;
- the medical device concerned is not included in the list provided in the Addendum to this document;
- the dossier mentioned in paragraph 3 of this document is not complete.
6. The Federal Service for Surveillance in Healthcare, within 3 working days of receipt of the aforementioned statement/conclusion as per paragraph 4 of this Statement, shall either:
a) take a positive decision on the marketing authorisation of the batch (lot) of the medical device, issue a related order by the Federal Service for Surveillance in Healthcare, send a registration certificate for the medical device concerned to the Applicant by registered mail or in e-form via regular communication channels, make a related record in the state register of medical devices and organizations (entities) and entrepreneurs producing or fabricating medical devices, stating information regarding the registered batch (lot) of the medical device concerned (in the event of a positive conclusion on the possibility of the marketing authorisation of the batch (lot) of the medical device in question); or
b) take a decision on the refusal to register the batch (lot) of the medical device concerned, and send a detailed justification for such refusal to the Applicant in the form of registered mail, or in e-form via regular communication channels (in the event of a negative statement in relation to the possibility of the marketing authorisation of the batch (lot) of the medical device concerned).
7. The registration certificate for the batch (lot) of the medical device concerned shall be issued in accordance with the requirements of paragraph 56 of the Registration Rules, and shall contain, among other information, the validity term, number of the batch (lot) of the medical device concerned and factory serial numbers of the devices in question (if applicable).
8. The Federal Service for Surveillance in Healthcare shall create a registration dossier for the batch (lot) of the medical device in question, using the following documents:
- an application for the marketing authorisation and related dossiers as per paragraph 3 of this document;
- the expert conclusion of the Expert Authority on the possibility of the marketing authorisation of the batch (lot) of the medical device concerned (either positive or negative);
- the decision on the marketing authorisation of the batch (lot) of the medical device concerned, in the form of an Order of the Federal Service for Surveillance in Healthcare;
- a copy of the marketing authorisation certificate.
- The state fee for issuing the registration certificate shall be paid in accordance with the laws of the Russian Federation governing taxes and fees.
- It is possible to import into the Russian Federation medical devices without registration, provided they are included in the list as per the Addendum to this document, in the amount necessary for any related tests (studies) or for the marketing authorisation process, without previous permission issued by the Federal Service for Surveillance in Healthcare. This provision is applicable until the complete resolution of an emergency situation threat or until the resolution of an existing emergency situation.
It is possible to sell or distribute disposable medical devices not registered in the Russian Federation if they are mentioned in the list provided in the Addendum to this document, without receiving a related permit from the Federal Service for Surveillance in Healthcare, if the medical devices in question are duly registered in the country of origin.
The applicant shall, within 3 working days after the import of such non-registered medical devices into the Russian Federation, submit to the Federal Service for Surveillance in Healthcare information regarding batches (lots) of imported non-registered medical devices, including but not limited to the following: name of the medical device concerned, the number of devices imported, the factory/serial number, if applicable, the batch (lot) number, date of manufacture, expiry term of service life, and the temporary storage address in the RF.
Any reusable medical devices imported into the Russian Federation which are not registered in accordance with the requirements of this document shall be either removed from the territory of the Russian Federation, or destroyed after 1 January, 2021.
The Applicant shall inform the Federal Service for Surveillance in Healthcare about any sales of the medical devices registered as per this document, as well as about the removal from the Russian Federation territory or disposal of non-registered medical devices within 5 days (maximum) after the completion of such activities.
- The Federal Service for Surveillance in Healthcare makes a decision on revoking the marketing authorisation of the batch (lot) of the medical device in accordance with subclauses ‘a’ to ‘e’ of paragraph 57 of the Registration Rules.
ADDENDUM
To the specific features of the circulation of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device
LIST
of medical devices intended for use in course of military conflicts, emergencies, emergency preventive actions, prevention and treatment of conditions representing a significant public threat, as well as conditions and damage resulting from the effect of unfavourable chemical, biological and radiological factors,
Type | Name of device | |
1. | 169180 | Immobile ventilator, high frequency, with electrical drive |
2. | 121270 | Manual ventilation device, disposable |
3. | 121180 | Manual ventilation device, reusable |
4. | 114040 | Portable ventilator, with air drive |
5. | 113890 | Portable ventilator, with electrical drive |
6. | 311390 | Portable ventilator, with air drive, high frequency |
7. | 314540 | Immobile ventilator, with air drive, high frequency |
8. | 314860 | Emergency vehicle ventilator, with air drive, high frequency |
9. | 318710 | CPAP mode ventilator, for home use |
10. | 326140 | CPAP mode ventilator, for newborns |
11. | 287620 | Negative pressure (suction) mode ventilator |
12. | 216540 | Pneumatically driven automated ventilation device, reusable |
13. | 232870 | ICU ventilator for newborn/adult patients |
14. | 232880 | ICU ventilator for newborn patients |
15. | 232890 | ICU ventilator, general purpose |
16. | 274590 | Emergency vehicle ventilator, with electrical drive |
17. | 275750 | A&R ventilator |
18. | 216260 | Pneumatically driven automated ventilation device, disposable |
19. | 115610 | Extracorporeal membrane oxygenator |
20. | 131520 | Intravascular membrane oxygenator |
21. | 113960 | Wound oxygenation system, disposable |
22. | 341760 | Wound oxygenation system, reusable |
23. | 142010 | Antigens for SARS coronavirus, IVD set, immunochromatographic assay, express test |
24. | 142100 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM, IVD set, for ELISA |
25. | 142120 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM, IVD set, for immunofluorescence assay |
26. | 142130 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM), IVD set, for ELISA |
27. | 142150 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM), IVD set, for immunofluorescence assay |
28. | 142160 | SARS coronavirus, nucleic acid, IVD set, for NA test |
29. | 142250 | Antibodies for SARS coronavirus, immunoglobulin class A (IgA)/IgG/IgM, IVD set, immunochromatographic assay, express test |
30. | 142260 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG), IVD set, for ELISA |
31. | 142280 | Antigens for SARS coronavirus, IVD set, for enzyme-linked immunosorbent assay (ELISA) |
32. | 142020 | Antibodies for SARS coronavirus, immunoglobulin class A (IgA)/IgG/IgM, IVD set, control material |
33. | 142030 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG) IVD set, calibrator |
34. | 142050 | Antigens for SARS coronavirus, IVD set, calibrator |
35. | 142060 | Antibodies for SARS coronavirus, immunoglobulin class |
A (IgA)/IgG/IgM, IVD set, reagent | ||
36. | 142070 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG) IVD set, control material |
37. | 142080 | Antigens for SARS coronavirus, IVD set, control material |
38. | 142090 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG) IVD set, reagent |
39. | 142110 | Antigens for SARS coronavirus, IVD set, reagent |
40. | 142140 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM IVD set, calibrator |
41. | 142170 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM IVD set, control material |
42. | 142180 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM) IVD set, calibrator |
43. | 142190 | SARS coronavirus, nucleic acid, IVD set, calibrator |
44. | 142200 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM IVD set, reagent |
45. | 142210 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM) IVD set, control material |
46. | 142220 | SARS coronavirus, nucleic acid, IVD set, control material |
47. | 142230 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM) IVD set, reagent |
48. | 142240 | SARS coronavirus, nucleic acid, IVD set, reagent |
49. | 142280 | Antigens for SARS coronavirus, IVD set, for enzyme-linked immunosorbent assay (ELISA) |
50. | 142290 | Antibodies for SARS coronavirus, immunoglobulin class A (IgA)/IgG/IgM, IVD set, calibrator |
51. | 142300 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG), IVD set, for immunofluorescence assay |
52. | 152850 | IVD set for extraction\isolation of nucleic acids |
53. | 349480 | Non-specific set for biomaterial sampling (sampling, pre-treatment and transportation) |
54. | 191780 | Artificial blood circulation (ABC) system, non-rolling pump type |
55. | 191810 | Artificial blood circulation (ABC) system, rolling pump type |
56. | 209090 | Extracorporeal oxygenation/ventilation system, portable |
57. | 104010 | Isolating overalls |
58. | 122540 | Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile |
59. | 122560 | Gloves for manual examination/interventions, made of natural hevea latex, powdered |
60. | 129350 | Surgical gown, disposable |
61. | 129380 | Surgical gown, reusable |
62. | 129870 | Isolating gown, reusable |
63. | 129880 | Isolating gown, disposable |
64. | 132380 | Facial mask for respiratory protection, reusable |
65. | 139350 | Gloves for manual examination/interventions, made of polychloroprene, non-powdered |
66. | 139360 | Gloves for manual examination/interventions, made of polychloroprene, powdered |
67. | 141650 | Overshoes non-conductive, non-sterile |
68. | 157010 | Patient’s gown, disposable |
69. | 157240 | Patient’s gown, reusable |
70. | 164050 | Gown for interventions, disposable |
71. | 164070 | Gown for interventions, reusable |
72. | 180770 | Breathing mask, general purpose |
73. | 181360 | Surgical isolating overalls |
74. | 181520 | Surgical mask, reusable |
75. | 181830 | Surgical breathing mask |
76. | 182450 | Surgical mask, disposable |
77. | 185830 | Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, non-sterile |
78. | 185850 | Gloves for manual examination/interventions, made of nitrile rubber, powdered |
79. | 188380 | Surgical overalls, cuffed |
80. | 205280 | Gloves for manual examination/interventions, made of vinyl, non-powdered |
81. | 205290 | Gloves for manual examination/interventions, made of vinyl, powdered |
82. | 248320 | Surgical overalls, disposable, non-sterile |
83. | 269290 | Overshoes, watertight |
84. | 293810 | Overshoes, conductive, non-sterile |
85. | 298450 | Gloves for manual examination/interventions, made of guayule latex, non-powdered |
86. | 311720 | Gloves for manual examination/interventions, made of ethylene vinyl acetate, non-powdered, non-sterile |
87. | 320790 | Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, with anti-bacterial properties |
88. | 321530 | Gloves for manual examination/interventions, made of polyisoprene, non-powdered |
89. | 332470 | Set of overalls for surgery/examination |
90. | 349230 | Gloves for manual examination/interventions, made of polyisoprene, powdered |
91. | 351490 | Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile, with anti-bacterial properties |
92. | 367580 | Facial mask for respiratory protection, disposable |
93. | 126370 | Infra-red thermometer for body temperature measurement, aural |
94. | 126390 | Infra-red thermometer for body temperature measurement, skin-touch type |
95. | 184110 | Medical thermometer with LCD display, disposable |
96. | 190030 | Electronic thermometer (AC mains power required) for continuous temperature measurement |
97. | 190040 | Electronic thermometer (battery power required) for continuous temperature measurement |
98. | 213720 | Thermometer for body temperature measurement, capillary type, alcohol filled |
99. | 213740 | Infra-red thermometer for body temperature measurement, capillary type, mercury filled |
100. | 254890 | Optical fiber-based thermometer with temperature probe |
101. | 266210 | Thermometer for body temperature measurement, electronic, for intermittent measurement mode |
102. | 300390 | Thermometer for body temperature measurement, with colour coded temperature indication |
103. | 335240 | Thermometer for body temperature measurement, capillary type, Gallium alloy filled |
104. | 339240 | Medical thermometer with LCD display, reusable |
105. | 341680 | Patient thermometer wireless, reusable |
106. | 341690 | Patient thermometer wireless, disposable |
107. | 358080 | Infra-red thermometer for body temperature measurement, skin-touch/aural type |
108. | 108170 | Outpatient registration device for body temperature monitoring |
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