Restrictions in sales for PVC medical devices

As amendments for RUSSIAN FEDERATION GOVERNMENT DECREE dated 5 February 2015 No. 102 – restrictions about PVC products.


Approved by Decree No. 968 of the Government of the Russian Federation

dated 14 August 2017

LIST OF DISPOSABLE MEDICAL PRODUCTS MADE OF POLYVINYL CHLORIDE PLASTICS ORIGINATING FROM FOREIGN STATES SUBJECT TO RESTRICTIONS IMPOSED WITH RESPECT TO APPROVAL THEREOF FOR PROCUREMENT FOR THE PURPOSE OF SATISFYING STATE AND MUNICIPAL NEEDS

List of amending documents (introduced by Decree No. 968 of the Government of the Russian Federation dated 14 August 2017)

Name of medical device Code in accordance with the All-Russian Classifier of Products by Types of Economic Activities (OKPD 2) ОК 034-2014 Medical device type code <*> Medical device type name <*> Distinctive features of the relevant medical device type <*>
1. Devices for the transfusion of blood, blood substitutes and infusion solutions 32.50.13.110

32.50.13.190

114090

131660

131850

131880

136330

145530

145570

167580

Devices (systems) for transfusion of blood, blood substitutes, and infusion solutions, including those with a microfilter, intended for the safe transfusion of blood and its components, blood substitutes and infusion solutions from polymeric and glass containers
Devices for the transfusion of infusion solutions and blood substitutes (PR) 136330 Basic kit for intravenous infusions
Devices for the transfusion of infusion solutions and blood substitutes (PR) 131850 Filter for infusion systems for intravenous infusions
Devices for the transfusion of infusion solutions and blood substitutes (PR) 131660 Kit for extending the lines intended for intravenous infusions
Devices for the transfusion of infusion solutions and blood substitutes (PR) 131880 Clamp for infusion systems designed for intravenous infusions equipped with a calibrated circular scale
Devices for the transfusion of infusion solutions and blood substitutes (PR) 114090 Kit for intravenous infusions made from non-absorbent material
Devices for the transfusion of infusion solutions and blood substitutes (PR) 167580 Kit for intravenous infusions equipped with a heating element
Devices for the transfusion of blood, blood components, and blood substitutes (PK) 145570 Blood transfusion kit
Devices for the transfusion of blood, blood components, and blood substitutes equipped with a microfilter (PK equipped with a microfilter) 145570 Blood transfusion kit
Devices for the transfusion of blood, blood components, and blood substitutes equipped with a microfilter (PK equipped with a microfilter) 145530 Blood transfusion filter
2. Containers for harvesting, storage, and transportation of donor blood and its components 32.50.13.190

32.50.50.000

144260

144270

144290

144300

144310

144320

145490

169870

178820

322610

Containers for harvesting, storage and transportation of donor blood and its components, including those equipped with a leukofilter, for obtaining whole blood from donors as well as donor blood components: erythrocyte mass, plasma, platelet concentrate and platelet-leukocyte mass, including blood components depleted of leukocytes
Containers for harvesting, storage, and transportation of donor blood and its components without haemopreservatives (dry), single-chamber (1000 ml)
Containers for harvesting, storage, and transportation of donor blood and its components without haemopreservatives (dry), single-chamber (300-450 ml)
Containers for harvesting, storage, and transportation of donor blood and its components without haemopreservatives (dry), dual-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, single-chamber 144260 Kit for donor blood, single-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, dual-chamber 144270 Kit for donor blood, dual-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, triple-chamber 144320 Kit for donor blood, triple-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative, four-chamber 144300 Kit for donor blood, four-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with a haemopreservative 178820 Paediatric kit for donor blood
Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter 144320 Kit for donor blood, triple-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter 178820 Paediatric kit for donor blood
Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter 144300 Kit for donor blood, four-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter 144310 Kit for donor blood, five-chamber
Containers for harvesting, storage, and transportation of donor blood and its components with an integrated leukocyte filter 144290 Kit for donor blood, multi-chamber
Polymeric containers for deep freezing (cryopreservation) of donor blood components 145490 Container for storage or cultivation of blood/tissues
Polymer containers for deep freezing (cryopreservation) of donor blood components 169870 Sterile container for cryopreservation of IVD (in vitro diagnostics device) samples
Devices for removal of leukocytes from donor blood and its components
Devices for removal of leukocytes from the donor blood plasma 322610 Plasma filter for apheresis systems
Devices for removal of leukocytes from the donor blood plasma (bedside) 322610 Plasma filter for apheresis systems
3. Consumables for artificial lung ventilation devices 32.50.13.190

32.50.50.000

110230

151440

165230

173070

185610

185620

185630

185640

218750

275820

318730

324650

322250

327610

327640

Consumables for artificial lung ventilation devices – disposable, sterile medical products for use in conjunction with artificial lung ventilation devices intended for supply and removal of controlled gas mixtures
Respiratory circuit for artificial lung ventilation devices 275820 Disposable anesthetic respiratory circuit
Respiratory circuit for artificial lung ventilation devices 185610 Disposable respiratory circuit for artificial lung ventilation devices
Respiratory filter for artificial lung ventilation devices 218750 Non-sterile heat/moisture exchanger/bacterial filter
Respiratory filter for artificial lung ventilation devices 324650 Sterile heat/moisture exchanger/bacterial filter
Respiratory filter for artificial lung ventilation devices 318730 Non-sterile disposable bacterial filter for medical gases
Respiratory filter for artificial lung ventilation devices 322250 Sterile disposable bacterial filter for medical gases
Humidifier for artificial lung ventilation devices 173070 Humidifier for respiratory mixtures without a heating element
Connector/ adapter for artificial lung ventilation devices 185640 Adapter for artificial lung ventilation devices
Connector/ adapter for artificial lung ventilation devices 327640 Sterile tube/mask connector for respiratory circuits
Connector/ adapter for artificial lung ventilation devices 165140 Disposable connector for respiratory circuits
Connector/ adapter for artificial lung ventilation devices 151450 Disposable Y-shaped connector for respiratory circuits
Connector/ adapter for artificial lung ventilation devices 327610 Non-sterile disposable tube/mask connector for respiratory circuits
Water trap for artificial lung ventilation devices 185620 Disposable water trap for artificial lung ventilation devices
4. Consumables for donor plasmapheresis/ thrombocytopheresis devices 32.50.13.190

32.50.50.000

Consumables for donor plasmapheresis/ thrombocytopheresis devices – disposable sterile medical products for use in conjunction with apheresis devices during the harvesting of donor plasma, platelet pools, and stem cells
Set/kit of consumables for harvesting plasma using the high-speed centrifugation method (HS technology)
Set/kit of consumables for harvesting plasma using the method of crossflow filtration on a rotating membrane filter
Tank for donor plasmapheresis devices
Container with ACD-A anticoagulant for donor plasmapheresis devices 145450 Solution for preservation of blood containing anticoagulant
Container with sodium citrate 4% anticoagulant for donor plasmapheresis devices 145450 Solution for blood preservation containing anticoagulant
Set of containers for donor plasmapheresis devices Set of containers for donor plasmapheresis devices, single-chamber
Set of containers for donor plasmapheresis devices Set of containers for donor plasmapheresis devices, dual-chamber
Set of containers for donor plasmapheresis devices Set of containers for donor plasmapheresis devices, triple-chamber
Set of lines for donor plasmapheresis devices 262870 Set of tubes for apheresis systems
Kit/set of consumables for donor plasmapheresis devices
Container with anticoagulant for donor thrombocytopheresis devices 145450 Solution for blood preservation containing anticoagulant
5. Consumables for artificial (extracorporeal) blood circulation devices 32.50.13.190

32.50.50.000

111480

115570

115610

131520

191470

191560

191600

191610

191680

191770

191800

228290

228320

235170

331910

332960

Consumables for artificial blood circulation devices (ABCD) – disposable, sterile medical products for use in conjunction with artificial blood circulation devices for temporary, complete or partial replacement for the pumping function of the heart if the latter cannot be performed by the relevant bodily organ.
Kit/set of consumables for artificial blood circulation devices
Set (oxygenator + lines) for artificial blood circulation devices
Oxygenator for artificial blood circulation devices 115610 Extracorporeal membrane oxygenator
Oxygenator for artificial blood circulation devices 115570 Extracorporeal bubble oxygenator
Oxygenator for artificial blood circulation devices 131520 Intravascular membrane oxygenator
Reinforced (armoured) arterial cannula for artificial blood circulation devices 191600 Arterial cannula for artificial blood circulation
Reinforced (armoured) paediatric arterial cannula for artificial blood circulation devices 331910 Paediatric cannula for artificial blood circulation
Femoral arterial cannula for artificial blood circulation devices 191610 Femoral cannula for artificial blood circulation
Femoral arterial cannula for artificial blood circulation devices 111480 Aortic cannula
Arterial cannula for artificial blood circulation devices 191470 Cannula for cardioplegic solution
Arterial cannula for artificial blood circulation devices 228290 Cannula for coronary arteries
Arterial cannula for artificial blood circulation devices 228320 Cannula for coronary sinuses
Femoral venous cannula for artificial blood circulation devices 191610 Femoral cannula for artificial blood circulation
Bicaval femoral venous cannula for artificial blood circulation devices 191680 Venous cannula for artificial blood circulation
Venous cannula for artificial blood circulation devices 298290 Transseptal cannula for artificial blood circulation systems
Angle-adjustable venous cannula for artificial blood circulation devices
Haemoconcentrator for artificial blood circulation devices 235170 Haemoconcentrator
Drainage/ suction for artificial blood circulation devices
Set of lines for artificial blood circulation devices 191560 Set of lines for artificial blood circulation systems
Set of lines for artificial blood circulation devices 191800 Set of lines for initial filling of artificial blood circulation systems
Set of lines for artificial blood circulation devices 332960 Connector for tubes for artificial blood circulation systems
Pump/ pump head for artificial blood circulation devices 191770 Centrifugal pump for artificial blood circulation systems
6. Urinals and colostomy bags 152440

152450

152460

152470

156370

156410

156420

200040

221840

221850

255030

Single-component colostomy bag 32.50.13.190

32.50.13.110

152450 Single-component closed colostomy bags Colostomy bags for rehabilitation of patients with abnormalities in faeces excretory function with specific diagnoses after surgeries, for use with colostomy, if applicable. Urinals for rehabilitation of patients with abnormalities in the natural outflow of urine after surgeries, for use with cytostome, if applicable.
Single-component colostomy bag 156410 Single-component drainable colostomy bag for intestinal stoma
Dual-component colostomy bag (ready for use) 156420 Open-type multicomponent colostomy bag for intestinal stoma
Dual-component colostomy bag (ready for use) 152460 Multicomponent closed colostomy bag for colostomy
Dual-component colostomy bag (ready for use)
Pouch for colostomy bags
Base plate for colostomy bags 221840 Convex base plate for colostomy bags
Base plate for colostomy bags 221850 Flat base plate for colostomy bags
Single-component urinal 255030 Single-component urological bag
Dual-component urinal 200040 Multicomponent urological bag
Urinal pouch 152470 Sterile closed non-portable urinal
Urinal pouch 152440 Non-sterile closed portable urinal
Urinal pouch 156370 Sterile urinal with a flush valve (non-wearable)