SBS - The Best Value in QMS software

Russia- Medical device with drug registration

apuigvert

Involved In Discussions
#1
Hello all! I have to register a medical device including gentamicin. Could anyone advise if it is mandatory to register the drug before the medical device submission and how long would it take?

Is there a shortcut to register both products together (medical device and drug)?

Thank you very much in advance! :thanks:
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
K Russia - Medical Device Regulation Including Definitions Needed Other Medical Device Regulations World-Wide 3
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
Y Multiple GOST R Medical Device Representatives in Russia Other Medical Device Regulations World-Wide 4
R Medical Device Certification Process of Argentina and Russia Other Medical Device Regulations World-Wide 2
M Class III Medical Device Registration in Russia Other Medical Device Regulations World-Wide 6
S Medical Device Registration Process in Russia Other Medical Device Related Standards 12
Marcel DS GOST-R (Type approval for Vehicles in Russia) Other ISO and International Standards and European Regulations 0
M One clinical design: Russia and Europe Other Medical Device and Orthopedic Related Topics 0
3 Russia - 1 Registration with Multiple Trade Names Other Medical Device Regulations World-Wide 3
T Russia - Customs Union - EAC Certification Mark CE Marking (Conformité Européene) / CB Scheme 2
Y Local Agent and Sales Rights in countries like Brazil and Russia Other Medical Device Regulations World-Wide 2
R IVD Registration requirements in Russia Other Medical Device Regulations World-Wide 1
AnaMariaVR2 A Profile of the Pharmaceutical Manufacturing Industry: Russia Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Is any standard in Russia equivalent to those of the family IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S MDDI article on UAE, Saudi, Belarus, Ukraine, Turkey, Russia Regulations Other Medical Device Regulations World-Wide 0
S Registration Requirements for X-ray & Oncology Product in Russia Other Medical Device Regulations World-Wide 4
P Have ISO 9001 and ISO 14001 requirements reached Russia? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
E ISO 9000 in Russia ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
O ISO 9000 in Russia - Seeking opinions of DNV - Noregian Det Norske Veritas Registrars and Notified Bodies 4
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 0
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
U EN 455-4 Accelerated Shelf Life tests for Medical Gloves Other Medical Device Related Standards 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Statistics and / or Forecasts on medical products exports from China Other Medical Device and Orthopedic Related Topics 1
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
F Medical cart self certification EU Medical Device Regulations 1
D Clinical Trial for Medical devices in Canada Canada Medical Device Regulations 1
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 0
M California Board of Pharmacy License for Medical Devices?? Other US Medical Device Regulations 6
P Retention Samples for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
A Medical First Article - Can it be a Delta? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4

Similar threads

Top Bottom