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 |