Order of Russian Government 804 from 02/06/2020

GOVERNMENT OF THE RUSSIAN FEDERATION

ORDER

No. 804, dated June 02, 2020

MOSCOW

To amend specific features of the circulation of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device

The Government of the Russian Federation has hereby ordered:

  1. To approve the submitted amendments introduced to specific features of the circulation of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device, approved by Order of the Government of the Russian Federation No. 430 dated April 03, 2020 “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” (Official Internet Portal of Legal Information (pravo.gov.ru), 2020, 6 April, No. 0001202004060033).
  2. This order comes into full force on the day of its official publication.

Chairman of the Government

of the Russian Federation                                                                              M. Mishustin

[SEAL: CENTRAL OFFICE OF THE GOVERNMENT OF THE RUSSIAN FEDERATION*

RECORDS MANAGEMENT DEPARTMENT OF THE

GOVERNMENT OF THE RUSSIAN FEDERATION

No. 1]

APPROVED by Order of the Government of the Russian Federation of June 02, 2020, no. 804

AMENDMENTS

introduced 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

  1. Item 1: replace the word “Addendum” with the words “Addendum No. 1”.
  2. Paragraph eight item 3: after the words “In the event of conducting”, add the words “in the Russian Federation”.
  3. Item 4: supplement with the following paragraphs:

“In the event that it is insufficient for the expert institution to make a conclusion on the materials and information contained in the documents submitted by the Applicant, provided for by item 3 of this document, the expert institution shall send the Applicant within 2 business days a request for submission of the necessary information indicating the nature of the comments and how to eliminate the same (hereinafter referred to as the request) by recorded delivery or in the form of an electronic document signed by electronic signature or delivered via telecommunication channels.

The Applicant must submit a response to the request of the expert institution within a period not exceeding 5 business days from the date of receipt of the request. The expert institution shall prepare a report within 2 business days of receiving a response to the Applicant’s request.

In the event of failure to submit a response to the request after 5 business days, the expert institution shall prepare a report on the basis of documents available.”

  1. Sub-item “e” item 5: replace the word “Addendum” with the words “Addendum No. 1”.
  2. First paragraph item 6: replace the number “3” with the number “2”.
  3. Add items 71–74 as follows:

“71. With regard to the medical devices specified in items 1-18 of Addendum No. 1 hereto, it is allowed to make changes to the name of the medical device in terms of changing information about its serial number (if any), batch (lot) number, in the event that other information contained in the documents of the registration dossier remained unchanged.

  1. 72. To amend documents in the registration dossier through changes specified in item 71 hereof, the Applicant shall submit (sends) to the Federal Service for Surveillance in Healthcare:

an application for amending the documents contained in the registration dossier (hereinafter the application for making amendments), carried out in accordance with paragraph 9 of the Registration Rules;

a copy of the document confirming the authority of the manufacturer’s (producer’s) authorised representative (if any);

documents confirming legal ownership by the Applicant of the batches (lots) of the medical device;

photographic images of the general configuration of the medical device together with the accessories needed for its intended application (in size at least 18 x 24 cm);

manufacturer’s document confirming that the medical device with declared serial numbers (if any), batch (lot) numbers is identical to that initially registered in accordance with the said document;

a copy of the marketing authorisation certificate;

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.

  1. 73. The Applicant shall submit to the Federal Service for Surveillance in Healthcare the application for amendments and documents referred to in item 72 hereof in hard copy by hand or send by recorded delivery with a list of enclosures, or as soft copy.

The Federal Service for Surveillance in Healthcare shall accept the application for amendments and documents referred to in item 72 hereof as per the checklist.

  1. 74. The Federal Service for Surveillance in Healthcare shall check within 3 business days of receipt of the application for amendments and documents referred to in item 72 hereof the completeness and accuracy of information contained therein and:

а)  makes a decision on amending the documents contained in the registration dossier, which is drawn up on the order of the Federal Service for Surveillance in Healthcare, entering the relevant information in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, or a decision to return the application for amendments and documents referred to in item 72 hereof, indicating the reasons for their return

  1. b) a written notification sent to the Applicant on the decision made by recorded delivery enclosing the renewed registration certificate (in the event of making changes to it) and the previously issued registration certificate with an indication of its invalidity (indicating the date).”
  2. Item 8:

а)  supplement sub-item “a” with the words “as well as the application for amendments and documents referred to in item 72 hereof”;

  1. b) supplement sub-item “d” with the words “and copies of notifications drawn up by the Federal Service for Surveillance in Healthcare”.
  2. Item 10:

а)  restate the first sentence in the first paragraph as follows:

“10. It is possible to import into the Russian Federation medical devices without authorisation issued by the Federal Service for Surveillance in Healthcare without registration, provided they are included in the list as per Addendum No. 1 to this document, in the amount necessary for any related tests (studies) or for the marketing authorisation process and further implementation.”

  1. b) second paragraph:

replace the words “It is possible to sell” with the words “It is possible to import into the Russian Federation, sell, transport, store, use and dispose (destroy)”;

replace the word “Addendum” with the words “Addendum No. 1”.

  1. c) restate the third paragraph as follows:

“The Applicant must, within 3 business days from the date of importation of unregistered medical devices into the Russian Federation, send to the Federal Service for Surveillance in Healthcare an information on batches (lots) of medical devices in accordance with Addendum No. 2 hereto.”

  1. d) reword the fifth paragraph as follows:

“The Applicant shall, on a weekly basis, until January 01, 2021, with regard to the unregistered and registered medical devices referred to in items 21-30 of Addendum No. 1 hereto in accordance with this document and with the marketing authorisation of medical devices rules, send to the Federal Service for Surveillance in Healthcare any information according to Addendum No. 2 hereto concerning implementation thereof, on their export from the territory of the Russian Federation or their destruction in accordance with this document.”

  1. Reword the Addendum to these specific features as follows:

“ADDENDUM No. 1 to specific features of the circulation of medical devices, including but not limited to the marketing authorisation of a batch (lot) of a medical device, approved by Order of the Government of the Russian Federation No. 804 dated June 02, 2020.”

LIST

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.

 

  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. 142010 Antigens for SARS coronavirus, IVD set, immunochromatographic assay, express test
22. 142100 Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/AgM, IVD set, for ELISA
23. 142120 Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/AgM, IVD set, for immunofluorescence assay
24. 142130 Antibodies for SARS coronavirus, immunoglobulin class M (IgM), IVD set, for ELISA test
25. 142150 Antibodies for SARS coronavirus, immunoglobulin class M (IgM), IVD set, for immunofluorescence assay
26. 142160 SARS coronavirus, nucleic acid, IVD set, for NA test
27. 142250 Antibodies for SARS coronavirus, immunoglobulin class A (IgA)/IgGAgM, IVD set, immunochromatographic assay, express test
28. 142260 Antibodies for SARS coronavirus, immunoglobulin class G (IgG), IVD set, for ELISA
29. 142280 Antigens for SARS coronavirus, IVD set, for enzyme-linked immunosorbent assay (ELISA)
30. 142300 Antibodies for SARS coronavirus, immunoglobulin class G (IgG), IVD set, for immunofluorescence assay
31. 343600 Reusable eye protective screen
32. 142020 Antibodies for SARS coronavirus, immunoglobulin class А (IgA)/IgGAgM 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 А (IgA)/IgGAgM 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)AgM 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. 142290 Antibodies for SARS coronavirus, immunoglobulin class А (IgA)/IgG/IgM, IVD set, calibrator
50. 152850 IVD set for extraction\isolation of nucleic acids
51. 349480 Non-specific set for biomaterial sampling (sampling, pre-treatment and transportation)
52. 191780 Artificial blood circulation (ABC) system, non-rolling pump type
53. 191810 Artificial blood circulation (ABC) system, rolling pump type
54. 209090 Extracorporeal oxygenation/ventilation system, portable
55. 104010 Isolating overall
56. 122540 Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile
57. 122560 Gloves for manual examination/interventions, made of natural hevea latex, powdered
58. 129350 Surgical gown, disposable*
59. 129380 Surgical gown, reusable
60. 129870 Isolating gown, reusable
61. 129880 Isolating gown, disposable*
62. 132380 Facial mask for respiratory protection, reusable
63. 139350 Gloves for manual examination/interventions, made of polychloroprene, non-powdered
64. 139360 Gloves for manual examination/interventions, made of polychloroprene, powdered
65. 141650 Overshoes non-conductive, non-sterile*
66. 157010 Patient’s gown, disposable*
67. 157240 Patient’s gown, reusable
68. 164050 Gown for interventions, disposable
69. 164070 Gown for interventions, reusable
70. 180770 Breathing mask, general purpose*
71. 181360 Surgical isolating overall
72. 181520 Surgical mask, reusable
73. 181830 Surgical breathing mask
74. 182450 Surgical mask, disposable*
75. 185830 Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, non-sterile
76. 185850 Gloves for manual examination/interventions, made of nitrile rubber, powdered
77. 188380 Surgical overall, cuffed*
78. 205280 Gloves for manual examination/interventions, made of vinyl, non-powdered
79. 205290 Gloves for manual examination/interventions, made of vinyl, powdered
80. 248320 Surgical overall, disposable, non-sterile
81. 269290 Overshoes, watertight
82. 293810 Overshoes, conductive, non-sterile*
83. 298450 Gloves for manual examination/interventions, made of guayule latex, non-powdered
84. 311720 Gloves for manual examination/interventions, made of ethylene vinyl acetate, non-powdered, non-sterile
85. 320790 Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, with anti-bacterial properties
86. 321530 Gloves for manual examination/interventions, made of polyisoprene, non-powdered
87. 332470 Set of overalls for surgery/examination
88. 349230 Gloves for manual examination/interventions, made of polyisoprene, powdered
89. 351490 Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile, with anti-bacterial properties
90. 367580 Facial mask for respiratory protection, disposable*
91. 126370 Infra-red thermometer for body temperature measurement, aural
92. 126390 Infra-red thermometer for body temperature measurement, skin-touch type
93. 184110 Medical thermometer with LCD display, disposable
94. 190030 Electronic thermometer (AC mains power required) for continuous temperature measurement
95. 190040 Electronic thermometer (battery power required) for continuous temperature measurement
96. 213720 Thermometer for body temperature measurement, capillary type, alcohol filled
97. 213740 Infra-red thermometer for body temperature measurement, capillary type, mercury filled
98. 254890 Optical fiber-based thermometer with temperature probe
99. 266210 Thermometer for body temperature measurement, electronic, for intermittent measurement mode
100. 300390 Thermometer for body temperature measurement, with colour coded temperature indication
101. 335240 Thermometer for body temperature measurement, capillary type, Gallium alloy filled
102. 339240 Medical thermometer with LCD display, reusable
103. 341680 Patient thermometer wireless, reusable
104. 341690 Patient thermometer wireless, disposable
105. 358080 Infra-red thermometer for body temperature measurement, skin-touch/aural type
106. 108170 Outpatient registration device for body temperature monitoring
107. 292390 Electronic micropipette
108. 216020 IVD semi-automatic thermocyclic nucleic acid thermocycler of laboratory grade
109. 215980 IVD automatic thermocyclic nucleic acid thermocycler of laboratory grade
110. 347450 IVD thermocyclic nucleic acid thermocycler for use near patient
111. 216000 IVD manual thermocyclic nucleic acid thermocycler
112. 318650 Automatic magnetic IVD particle separation device
113. 228180 Exchange window
114. 318660 Automatic device for preparation of IVD nucleic acids samples
115. 207000 IVD virus transport medium
116. 340600 Disposable container for IVD analysis
117. 259780 Non-specialized IVD sample collection sterile container with no additives
118. 108750 General-purpose sterile laboratory container
119. 259720 Non-specialized, non-sterile IVD sampling container with no additives
120. 293350 IVD vacuum collection tube for blood samples with dextrose B citrate (ACD-B)
121. 293360 IVD vacuum collection tube for blood samples with K3EDTA and sodium fluoride
122. 293370 IVD vacuum collection tube for blood samples with no additives
123. 293400 IVD vacuum collection tube for blood samples with potassium oxalate and sodium fluoride
124. 293420 IVD vacuum collection tube for blood samples with sodium heparin
125. 293440 IVD vacuum collection tube for blood samples with dextrose A citrate (ACD-A)
126. 293450 IVD vacuum collection tube for blood samples with ammonium heparin and separation gel
127. 293460 IVD vacuum collection tube for blood samples with lithium heparin and lithium iodoacetate
128. 293470 IVD vacuum collection tube for blood samples with CPhDA*
129. 293480 IVD vacuum collection tube for blood samples with lithium heparin and separation gel
130. 293500 IVD vacuum collection tube for blood samples with K2EDTA*
131. 293550 Vacuum container for IVD saliva samples with sodium azide
132. 264440 IVD centrifugal sterile tube
133. 134590 Cryobiological container
134. 167480 IVD non-vacuum collection tube for blood samples with no impurities,
135. 259790 IVD non-specialized tissue collection container with formalin solution
136. 264460 IVD centrifugal non-sterile tube
137. 167550 IVD non-vacuum collection tube for blood samples with sodium citrate
138. 167430 IVD non-vacuum collection tube for blood samples with EDTA*
139. 167440 IVD non-vacuum collection tube for blood samples with separation gel
140. 108710 General-purpose reusable laboratory container
141. 293660 IVD vacuum collection tube for blood samples with K3EDTA*
142. 293570 IVD vacuum collection tube for blood samples with coagulation activator
143. 167450 IVD non-vacuum collection tube for blood samples with lithium heparin
144. 293760 IVD vacuum collection tube for blood samples with lithium heparin
145. 293540 IVD vacuum collection tube for blood samples with sodium citrate
146. 343590 Reusable facial protective screen
147. 107700 Facial protective screen*
148. 274530 Eye protective screen*
149. 127430 Ultrasonic respiratory air/gas humidifier
150. 152090 Humidifier for respiratory mixtures with a heating element
151. 173070 Humidifier for respiratory mixtures without a heating element
152. 318730 Non-sterile disposable bacterial filter for medical gases
153. 324930 Non-sterile reusable bacterial filter for medical gases
154. 165140 Disposable connector for respiratory circuits
155. 165230 Reusable connector for respiratory circuits
156. 185620 Disposable moisture collector for artificial lung ventilation devices
157. 185630 Reusable moisture collector for artificial lung ventilation devices
158. 109720 Reusable facial mask of the continuous/two-phase positive airway pressure device,
159. 109740 Oral mask for artificial ventilation with continuous/two-phase positive pressure
160. 109710 Disposable facial mask of the continuous/two-phase positive airway pressure device,
161. 271370 Reusable mask for artificial lung ventilation
162. 271390 Disposable mask for artificial lung ventilation
163. 110230 Reusable tube/mask connector for respiratory circuits
164. 136690 Connector with plug for quick connection of medical air cylinders
165. 136820 Connector for quick connection of medical air cylinders with f-port
166. 151440 Reusable Y-shaped connector for respiratory circuits
167. 298870 Connector for quick connection in the helium-oxygen mixture supply system with f-port
168. 298880 Connector for quick connection in the helium-oxygen mixture supply system, with m-port
169. 275840 Connector for quick connection in the exhaust system of anaesthetic gases with m-port
170. 250830 Connector for NOS quick connection with f-port
171. 250770 Connector for NOS quick connection with m-port
172. 250740 Connector for hyponitrous oxide quick connection with f-port
173. 250710 Connector for hyponitrous oxide quick connection with m-port
174. 283370 Disposable bag for respiratory circuits
175. 283460 Reusable bag for respiratory circuits
176. 283480 Reusable gas flow sensor for breathing system
177. 105850 Nasal cannula for oxygen supply during mechanical ventilation with continuous positive pressure
178. 136410 Standard nasal cannula for oxygen supply*
179. 185520 Respiratory tube holder
180. 139780 Reusable spacer for nebulizer or inhaler
181. 345540 Disposable spacer for nebulizer or inhaler
182. 298900 Helium and oxygen mixer for breathing mixture
183. 344690 Oxygen/air gas mixer for emergency aid
184. 132340 Respiratory airway cleaning/suction tube for emergencies
185. 135720 Endobronchial tube
186. 136260 Disposable standard endotracheal tube
187. 136270 Reusable standard endotracheal tube
188. 136490 Reusable standard tracheostomy tube
189. 136500 Disposable standard tracheostomy tube
190. 136850 Medical air low-pressure tube
191. 169050 Reusable reinforced endotracheal tube
192. 169080 Disposable reinforced tracheostomy tube
193. 169100 Disposable reinforced endotracheal tube
194. 183640 Coaxial tube for hyponitrous oxide cylinder*
195. 191040 Disposable suction/flushing tube
196. 218780 Endotracheal antibacterial tube*
197. 250810 Low-pressure tube for hyponitrous oxide
198. 269300 Laser-resistant endotracheal tube
199. 271240 Disposable respiratory tube for gas collection/monitoring
200. 274010 Aerosol supply tube*
201. 275760 Tube for evacuating waste anaesthetic gases
202. 279070 Endotracheal tube with suction cup
203. 283260 Breathing system tube
204. 298800 Disposable vacuum tube
205. 298830 Reusable vacuum tube
206. 301700 Endotracheal tube for high-frequency mechanical ventilation
207. 332650 Disposable sterile respiratory tube for gas collection/monitoring
208. 332660 Reusable respiratory tube for gas collection/monitoring
209. 333030 Tube for monitoring pressure to the artificial blood circulation (ABC) system
210. 333510 Reusable respiratory tube for inspiratory/expiratory tube
211. 334110 Spirometry tube/lung function assessment
212. 348290 Duct cuff inflation tube
213. 349970 Customized tracheostomy tube
214. 351410 Reusable low-pressure gas tube for general use
215. 354450 Disposable non-sterile tube for inspiratory/expiratory extension
216. 357210 Reusable reinforced tracheostomy tube
217. 360480 Disposable sterile tube for inspiratory/expiratory extension
218. 207560 Reusable adapter for inhalation therapy
219. 110260 Replaceable filter for heat/moisture exchanger
220. 173800 Protective filter for tracheostomy*
221. 181090 Surgical instrument compressed air filter
222. 218750 Non-sterile heat/moisture exchanger/bacterial filter
223. 172720 Reusable oropharyngeal airway
224. 172730 Disposable oropharyngeal airway
225. 254040 Disposable tracheal airway with oesophageal obturator
226. 254120 Reusable oesophageal airway
227. 254170 Disposable airway with oesophageal obturator
228. 254240 Reusable tracheal airway with oesophageal obturator
229. 254280 Reusable nasopharyngeal airway
230. 254300 Disposable nasopharyngeal airway
231. 289900 Reusable stylet for airway
232. 290000 Disposable stylet for airway*
233. 318100 Device for pumping air out of a cuff for a laryngeal airway
234. 318110 Introducer for laryngeal airway
235. 283330 Disposable mouthpiece for respiratory circuits
236. 283380 Reusable mouthpiece for respiratory circuits
237. 325840 Filter/mouthpiece for checking lung function*
238. 350590 Valsalva’s manoeuvre standard mouthpiece*
239. 351540 Cardiopulmonary resuscitation mouthpiece/cover
240. 364520 Valsalva’s manoeuvre manometric mouthpiece
241. 172910 Tracheal tube cuff*
242. 172970 Tracheal tube cuff expander
243. 173780 Tracheostomy tube cuff
244. 289870 Pump for manual injection of air into the cuff of the endotracheal tube
245. 289980 Endotracheal tube cuff pressure monitor
246. 289880 Reusable endotracheal tube introducer
247. 289990 Disposable endotracheal tube introducer
248. 172930 Vacuum regulator in aspiration system for trachea
249. 108960 Disposable end-expiratory positive pressure valve
250. 109060 Reusable end-expiratory positive pressure valve
251. 124510 Disposable mechanical expiratory valve
252. 124630 Reusable mechanical expiratory valve
253. 135690 Endobronchial valve
254. 135700 Endobronchial valve catheter*
255. 135710 Endobronchial valve sizing kit
256. 168130 Reusable embedded check valve
257. 168140 Disposable embedded check valve
258. 236910 Exhalation valve with RF sensor*
259. 249420 Haemostatic valve obturator*
260. 260200 Connector for needleless connection with direct-flow valve
261. 262380 Reusable non-reversible valve
262. 321960 Disposable non-reversible valve
263. 337110 Resistance valve for cardiopulmonary resuscitation, for inhalation/exhalation
264. 327780 Medical gas flowmeter with Thorpe tube
265. 151450 Disposable Y-shaped connector for respiratory circuits
266. 182020 Surgical instrument compressed air quick connector with f-port
267. 182030 Surgical instrument compressed air quick connector with m-port
268. 256770 Reusable low-pressure tube connector
269. 275690 Connector for quick connection in the exhaust system of anaesthetic gases with f-port
270. 298760 Vacuum quick connector with f-port
271. 298770 Vacuum quick connector with m-port
272. 327610 Disposable non-sterile tube/mask connector for respiratory circuits
273. 327640 Disposable sterile tube/mask connector for respiratory circuits
274. 115570 Extracorporeal vesiculate oxygenator*
275. 191500 Air bubble/fluid level detector for the artificial blood circulation (ABC) system
276. 191740 The air/foam detector for the artificial blood circulation (ABC) system
277. 191920 Cardiotomy reservoir*
278. 191770 Centrifugal pump for the artificial blood circulation (ABC) system
279. 264520 Centrifugal pump for the artificial blood circulation (ABC) system with power supply
280. 115660 Device for extracorporeal monitoring of blood gases/pH
281. 191440 Cardioplegic solution adapter*
282. 191560 Set of tubes for the artificial blood circulation (ABC) system
283. 327170 General-purpose laboratory research tablet
284. 327110 IVD microplate*
285. 209360 Mobile unit for creating a laminar flow
286. 182750 Surgical unit for creating a laminar flow
287. 152700 Highly efficient stationary air filter
288. 152690 Mobile highly effective air filtering purifier
289. 131980 UV bactericidal lamp
290. 347590 UV light disinfection system
291. 157200 Pulse oximetry patient monitoring system module
292. 150020 Pulse oximeter with power supply
293. 149980 Battery powered pulse oximeter
294. 218410 Telemetry pulse oximeter
295. 220960 Thermographic camera
296. 126320 Infrared Thermographic System
297. 157680 Medical bedside console with communications
298. 259390 Universal console with communications
299. 259380 Universal console with communication leads and ceiling mount
300. 188360 High-flow infusion pump with the ability to heat the injected media
301. 288180 Elastomeric infusion pump*
302. 124530 Reusable mechanical general-purpose infusion pump
303. 183030 Multi-channel general-purpose infusion pump
304. 260420 General-purpose infusion pump with power supply
305. 329460 Battery-powered general-purpose infusion pump
306. 333950 Disposable mechanical general-purpose infusion pump
307. 324350 Disposable flexible, single-use video bronchoscope
308. 179300 Reusable flexible, single-use video bronchoscope
309. 143930 Hard bronchoscope
310. 179100 Flexible optical fiber bronchoscope
311. 182740 Surgical system for suction/irrigation
312. 358710 General-purpose electric aspiration surgical system
313. 358690 General-purpose pneumatic aspiration surgical system
314. 228190 Laminar air tent
315. 157130 Multifunctional patient monitoring system module
316. 190840 System for monitoring physiological parameters of several patients
317. 190850 System for monitoring physiological parameters of individual patient
318. 143910 Blood refrigerator
319. 215850 Pharmaceutical refrigerator
320. 261620 Basic laboratory refrigerator
321. 321680 Blood refrigerator/freezer
322. 352570 Laboratory refrigerator/freezer
323. 352580 Pharmacy refrigerator/freezer
324. 120210 Mechanical hospital bed
325. 136210 Standard hospital bed with electrical drive
326. 131200 Hospital bed with hydraulic drive
327. 248410 Microsample centrifuge
328. 214590 Cytological centrifuge
329. 117910 High speed floor-mounted centrifuge
330. 143900 Blood bank centrifuge
331. 260430 General-purpose centrifuge
332. 274470 Floor-mounted low speed centrifuge without cooling
333. 274480 Floor-mounted low speed centrifuge with cooling
334. 261720 Laboratory thermostat
335. 260440 General-purpose thermostat
336. 232840 Laboratory thermostat for clean rooms
337. 261300 Laboratory water bath with shaking action
338. 335060 Laboratory thermostatic stirrer
339. 327810 Medical gas flowmeter, with dial
340. 327750 Medical gas flowmeter with Bourdon tube pressure gauge
341. 156250 Respiratory oxygen therapy system
342. 191160 Stationary oxygen concentrator
343. 113810 Portable oxygen concentrator
344. 292810 Pipette tip*
345. 352690 IVD pipette tip*
346. 327180 IVD microplate-film*
347. 335550 Tray for multi-channel dispensers
348. 293530 IVD vacuum collection tube for blood samples with no additives/metal impurities
349. 272240 Antiseptic cloth*
350. 261820 Disposable general-purpose applicator/swab with absorbent tip, single use
351. 186000 IVD automatic immunochemiluminescent analyzer
352. 109770 Detergent/cleaning IVD-solution for automated/semi-automated systems
353. 160170 Buffer wash solution for automatic immunochemiluminescent analyzers
354. 231970 Substrate solution for automatic immunochemiluminescent analyzers
355. 231790 IVD flushing solution/flushing buffer for immunochemistry
356. 324430 Disposable reaction cuvettes/cuvettes for IVD laboratory analyser
357. 324440 Reusable reaction cuvettes/cuvettes for IVD laboratory analyser
358. 216350 Stationary electronic blood pressure monitor with automatic air inflation
359. 216560 Electronic monitor, automatic, portable, with finger cuff blood pressure
360. 216630 Electronic monitor, automatic, portable, with shoulder/wrist cuff blood pressure
361. 218430 Telemetry blood pressure meter
362. 206980 Kit for collecting and transporting samples with viruses
363. 347240 Oral oropharyngeal specimen collection kit

______________________

*Disposable medical devices.

  1. Supplement with Addendum No. 2 as follows:

“ADDENDUM No. 2 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”

INFORMATION

on medical devices submitted to the Federal Service for Surveillance in Healthcare

  1. Name of the medical device (for registered medical devices, in accordance with the marketing authorisation).
  2. Number and date of marketing authorisation for the medical device (for registered medical devices).
  3. Hardware version or model of the medical device (if available).
  4. Type code and name of the type of medical device in accordance with the nomenclature classification of medical devices by type approved by the Ministry of Healthcare of the Russian Federation.
  5. Name of the medical device manufacturer (for registered medical devices, in accordance with marketing authorisation).
  6. Name of the country of the medical device manufacturer (for registered medical devices, in accordance with marketing authorisation).
  7. Address of the medical device production site (for registered medical devices, in accordance with marketing authorisation).
  8. Composition and assembly units of the medical device (if available) and the list of accessories (if available) (for registered medical devices, in accordance with marketing authorisation).
  9. Batch (lot) number, serial number.
  10. Size of batch (lot) or the number of serial numbers, itemised.

 

  1. Date of manufacture (production) of the medical device.
  2. Expiry date of the medical device.
  3. Information on the Applicant specified in item 3 of the specific features of the circulation of medical devices, including the state registration of a batch (lot) of medical devices, approved by Order of the Government of the Russian Federation No. 430 dated April 03, 2020 “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” (full and abbreviated (if any) name, including the company name, legal form of the legal entity, its address, taxpayer identification number, main state registration number or surname, name and patronymic (if any), address of the place of residence of the individual entrepreneur, data on the identity document, main state registration number of the individual entrepreneur, phone number and email address).
  4. Information about the person who stores the batch (lot), serial number of the medical device (full and abbreviated (if any) name, including the company name, legal form of the legal entity, its address, tax identification number, main state registration number or surname, name, patronymic (if any) of the individual entrepreneur, address of residence, data on the identity document, main state registration number of the individual entrepreneur, phone number and email address).

Information about the person to whom the batch (lot) was sold, serial numbers of the medical device (full and abbreviated (if any) name, including company name), legal form of the legal entity, its address, tax identification number, main state registration number or surname, name, patronymic (if any) of the individual entrepreneur, address of residence, data on the identity document, main state registration number of the individual entrepreneur, phone number and email address