of December 10, 2021 No. 2250
About modification of the Order of the Government of the Russian Federation of April 3, 2020 No. 430
The government of the Russian Federation decides:
1. Approve the enclosed changes which are made to the order of the Government of the Russian Federation of April 3, 2020 No. 430 "About features of the address of medical products, including state registration of series (batch) of medical product" (The Russian Federation Code, 2020, No. 15, Art. 2284; No. 23, Art. 3667; No. 47, Art. 7530; 2021, No. 11, Art. 1829).
2. Determine that:
a) registration certificates on series (batch) of medical product which is intended for application in the conditions of military operations, emergency situations, preventions of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors, according to the list according to appendix No. 1 to features of the address of medical products, including the state registration of series (batch) of medical product approved by the order of the Government of the Russian Federation of April 3, 2020 No. 430 "About features of the address of medical products, including state registration of series (batch) of medical product" (further - medical product), issued according to the procedure, established by the specified resolution, about day of entry into force of this resolution, which effective period is established till January 1, 2022, are valid till January 1, 2025 without replacement of the registration certificate by series (batch) of medical product;
b) To the Federal Service on supervision in the field of health care till January 1, 2022 to enter in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products, data on change of effective period of the registration certificates specified in the subitem "an" of this Item.
Russian Prime Minister
M. Mishustin
Approved by the Order of the Government of the Russian Federation of December 10, 2021 No. 2250
1. In Item 2 of the word "January 1, 2022." shall be replaced with words "on January 1, 2025".
2. In features of the address of medical products, including the state registration of series (batch) of medical product approved by the specified resolution:
a) in Item 2 of the word "January 1, 2022." shall be replaced with words "on January 1, 2025";
b) in Item 10:
in paragraph four of the word "January 1, 2022." shall be replaced with words "on January 1, 2025";
in paragraph five of the word "January 1, 2022." shall be replaced with words "on January 1, 2025", shall be replaced with words the words "specified in Items 21 - 30" "specified in Items 19 - 78";
c) to state appendix No. 1 to the specified features in the following edition:
"Appendix No. 1
to features of the address of medical products, including state registration of series (batch) of medical product
(in edition of the Order of the Government of the Russian Federation of December 10, 2021 No. 2250)
The list of medical products which are intended for application in the conditions of military operations, emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors
|
|
Type |
Name |
|
1. |
169180 |
The medical ventilator stationary high-frequency with the electric drive |
|
2. |
275750 |
Medical ventilator of anesteziologicheskiya |
|
3. |
311390 |
Medical ventilator portable, high-frequency with pneumatic actuator |
|
4. |
314860 |
The medical ventilator high-frequency with pneumatic actuator for transportation of patients |
|
5. |
232870 |
The medical ventilator for intensive therapy neonatal adults |
|
6. |
232880 |
The medical ventilator for intensive therapy neonatal |
|
7. |
232890 |
The medical ventilator of general purpose for intensive therapy |
|
8. |
216540 |
The medical ventilator is pneumatic automatic, reusable use |
|
9. |
216260 |
The medical ventilator is pneumatic automatic, disposable <*> |
|
10. |
114040 |
The medical ventilator portable with pneumatic actuator |
|
11. |
113890 |
The medical ventilator is portable electric |
|
12. |
121180 |
Medical ventilator manual, reusable use |
|
13. |
121270 |
Medical ventilator manual, disposable <*> |
|
14. |
287620 |
The medical ventilator with negative pressure |
|
15. |
318710 |
The medical ventilator with permanent positive pressure for home use |
|
16. |
326140 |
The medical ventilator with permanent positive pressure for newborns |
|
17. |
274590 |
The medical ventilator with the electric drive for transportation of patients |
|
18. |
314540 |
The medical ventilator stationary high-frequency with pneumatic actuator |
|
19. |
142280 |
SARS Coronavirus IVD antigens, set, immunoenzymatic analysis (IFA) |
|
20. |
142010 |
SARS Coronavirus IVD antigens, set, immunokhromatografichesky analysis, express-analysis |
|
21. |
142250 |
SARS antibody Coronavirus immunoglobulin A (IgA)/IgG/IgM of IVD, set, immunokhromatografichesky analysis, express-analysis |
|
22. |
142260 |
SARS class antibody Coronavirus immunoglobulin G (IgG) of IVD, set, immunoenzymatic analysis (IFA) |
|
23. |
142300 |
SARS class antibody Coronavirus immunoglobulin G (IgG) of IVD, set, immunofluorescent analysis |
|
24. |
142100 |
SARS class antibody Coronavirus immunoglobulin G (IgG)/IgM of IVD, set, immunoenzymatic analysis (IFA) |
|
25. |
142120 |
SARS class antibody Coronavirus immunoglobulin G (IgG)/IgM of IVD, set, immunofluorescent analysis |
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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