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