Fast track registration for products from special list

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products:

  • medical devices with 1 risk class are included in this list (for example, gloves),
  • “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate is issued (during 150 working days after registration certificate is issued). This scheme is really unexpected and not typical for current regulation for medical devices inside Russia,
  • limitation in technical testing and biocompatibility trials – only FGBU VNIIIMT test reports are accepted.

Update for Order of Russian Government 1416 was signed at 18th of March, we are waiting for further information about application date.

Update. Order of Russian Government 299 from 18th of March 2020 (list of products fall under regulation):

LIST of medical devices with low risk of usage regarding which specific rules for marketing authorization apply risk of usage regarding which specific rules for marketing authorization apply

Type Name of device
 

1.

 

104010

 

Isolating overall

2. 122540 Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile
3. 122560 Gloves for manual examination/interventions, made of natural hevea latex, powdered
4. 129350 Surgical gown, single use
5. 129380 Surgical gown, reusable
6. 129870 Isolating gown, reusable
7. 129880 Isolating gown, single use
8. 132380 Facial mask for respiratory protection, reusable
9. 139350 Gloves for manual examination/interventions, made of polychloroprene, non-powdered
10. 139360 Gloves for manual examination/interventions, made of polychloroprene, powdered
11. 141650 Overshoes non-conductive, non-sterile
12. 157010 Patient’s gown, single use
13. 157240 Patient’s gown, reusable
14. 164050 Gown for interventions, single use
15. 164070 Gown for interventions, reusable
16. 180770 Breathing mask, general purpose
17. 181360 Surgical isolating overall
18. 181520 Surgical mask, reusable
19. 181830 Surgical breathing mask
20. 182450 Surgical mask, single use
21. 185830 Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, non-sterile
22. 185850 Gloves for manual examination/interventions, made of nitrile rubber, powdered
23. 188380 Surgical overall, cuffed
24. 205280 Gloves for manual examination/interventions, made of vinyl, non-powdered
25. 205290 Gloves for manual examination/interventions, made of vinyl, powdered
26. 248320 Surgical overall, single use, non-sterile
27. 269290 Overshoes, watertight
28. 293810 Overshoes, conductive, non-sterile
29. 298450 Gloves for manual examination/interventions, made of guayule latex, non-powdered
30. 311720 Gloves for manual examination/interventions, made of ethylene vinyl acetate, non-powdered, non-sterile
31. 320790 Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, with anti-bacterial properties
32. 321530 Gloves for manual examination/interventions, made of polyisoprene, non-powdered
33. 332470 Set of overalls for surgery/examination
34. 349230 Gloves for manual examination/interventions, made of polyisoprene, powdered
35. 351490 Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile, with anti-bacterial properties
36. 367580 Facial mask for respiratory protection, single use