SBS - The best value in QMS software

Medical Device Registration Process in Russia

S

schorre

#1
Hello Everyone:

Our Moscow office recently wrote a very detailed overview of the Russian medical device regulatory process for the Journal of Medical Device Regulation. I thought forum members might find it to be helpful.

The process is very complicated so the article is about 3,700 words long but provides a good overview of what is involved. We are also working on a regulatory flowchart that I will share with members once we have it completed.

Regards,

Chris Schorre
Emergo Group, Inc.
 

Attachments

Elsmar Forum Sponsor
M

MIREGMGR

#2
Does Roszdravnadzor's post market surveillance requirement (page 7 of the PDF) require and allow reporting of incidents anywhere, or only within the Russian Federation? Does their requirement emphasize speed of reporting even if facts are not yet certain, or does it permit delay until facts and fault are understood? Does it disclaim liability determination in regard to the Russian legal system?
 
Y

yana prus

#3
Does Roszdravnadzor's post market surveillance requirement (page 7 of the PDF) require and allow reporting of incidents anywhere, or only within the Russian Federation? Does their requirement emphasize speed of reporting even if facts are not yet certain, or does it permit delay until facts and fault are understood?
After reviewing the Order No. 735, my understanding is that it is not specifically restricted to incidents in Russian Federation. Withing 5 working days from the incident reporting, registration dept. manager has to provide detailed report to head of Roszdravnadzor regarding the incident. The head of Roszdravnadzor within 5 working days after receiving the report or further data regarding the investigation results, can take the decisions detailed in the page 7.

 
A

Ana Fuduric

#4
Hello all,

Excellent document. Is it still valid or maybe there was some changes in meantime?

Are there any other guidance documents for Russian market regarding single-
use medical devices class I, Is and IIa (products made of gauze and cotton wool)?

Does anybody know is there some necessary regulations for importing simple hygienic products (cotton wool products) to Russian market?

Thank you all in advance
Ana
 
R

Raymond12

#7
Dear All,

Thank you for this very interesting thread so far,

I am due to commence re registration for a class IIa medical device in Russia.

What if any differences are there between initial registration and re registration? Such as cost, timescales, is there an audit required?

If anyone could shed some light on this it would be greatly appreciated

Many thanks
Ray
 
M

medic61

#8
Word to the wise...hire a certified translator to confirm that documents in Russion match the English versions and that you agree with it before signing anything.
Medic
 
C

CBAL08

#9
Just a concern- What would be the tentative cost and time frame for registrtion of Class I and II ( FDA)in Russia. Anyone who could help us with this?

Plus the translation fees for documents? SAy per page/ in Euro or US $ .

Thank you in advance
 
M

medic61

#10
I don't think you can figure out the costs ahead of time. We spent 16,000.00 USD and still had to pay for an attorney in Russia to complete the project. The attorney has to hold the registration certificate in case the government needs it again. We do not want the customer to keep it. The attorney's office did the translations. I hope the customer will spend enough with us this year to make up for it.
I wish you luck!
Medic
 
Thread starter Similar threads Forum Replies Date
H Medical device Product Registration Registrars and Notified Bodies 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
MDD_QNA Medical Device registration Argentina Other Medical Device Regulations World-Wide 0
R Medical device registration in Iran Other Medical Device Regulations World-Wide 0
G Device Registration Ammendments - Modifications to Medical Devices Other Medical Device Regulations World-Wide 4
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
A Philippines Medical Device Registration Transfer Other Medical Device Regulations World-Wide 1
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
S Uzbekistan - Medical Device Registration Other Medical Device Regulations World-Wide 1
L Medical device registration in African/Asian countries Other Medical Device Regulations World-Wide 11
S FEE Registration LINK - EU Medical Device CE Marking (Conformité Européene) / CB Scheme 6
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
A Russia- Medical device with drug registration Other Medical Device Regulations World-Wide 0
3 Egypt Medical Device Registration: Only required for Sterile Medical Devices? Other Medical Device Regulations World-Wide 10
S Australian Registration of Non-CE Marked Medical Device CE Marking (Conformité Européene) / CB Scheme 2
Q Medical Device Establishment Registration/Listing for Foreign Private Labeler Other US Medical Device Regulations 8
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 10
B Strategy for Registration a Medical Device in China China Medical Device Regulations 2
3 Medical Device Registration Phillippines Other Medical Device Regulations World-Wide 4
Q RFID (radio frequency identification) registration for Medical Device Other Medical Device Regulations World-Wide 6
G Design Philosophy - Iran Medical Device Registration Other Medical Device Regulations World-Wide 7
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
G Medical Device Registration in Pakistan Other Medical Device Regulations World-Wide 3
F Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
K Medical device registration in Brunei Other Medical Device Regulations World-Wide 1
N Malaysian Medical Device Registration Requirements Other Medical Device Regulations World-Wide 8
I FDA Medical Device Registration - Scenario - Two Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Medical Device Registration and Listing Help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
B Taiwan Medical Device registration - Production or legal office Other Medical Device Regulations World-Wide 6
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
J Medical Device Registration in Venezuela Other Medical Device and Orthopedic Related Topics 4
JoCam Choose Medical Device Distributors prior to Device Registration? Other Medical Device Regulations World-Wide 6
E Medical Device Registration requirements for Bahrain Other Medical Device Regulations World-Wide 4

Similar threads

Top Bottom