Distributor of Medical Devices - Is ISO certification required?

D

dionysisf

Hello,

We are a medical devices manufacturer (ISO 13485 certified) and we sell our CE marked devices in Europe via Distributors.

The question is if the distributor has to be ISO 9001 or 13485 certified?

It is noted that some of our distributors are responsible only for the distribution of the devices and others perform also the Preventive Maintenance Service of the devices (trained and authorized by the manufacturer).

Thanks in advance
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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
K Selling Medical Devices in Canada - Distributor? Private Label? Canada Medical Device Regulations 10
S Resterilization of Disposable Medical Devices by a Distributor Other Medical Device and Orthopedic Related Topics 5
T Local Distributor and/or Local Registration for Medical Devices Required? Other Medical Device Regulations World-Wide 2
W Distributor Requirements for Sterile Disposable Medical Devices EU Medical Device Regulations 8
I FDA regulations for medical devices distributor in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Medical Devices Distributor and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
C Labeling of Medical Devices - Distributor replacing device serial number label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Medical Device License as Distributor Canada Medical Device Regulations 12
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
A NCR, NCMR, CAPA, Deviations - Medical Device Distributor Nonconformance and Corrective Action 2
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
F Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
A Implementing Risk Management in a Medical Device "Distributor Only" company ISO 13485:2016 - Medical Device Quality Management Systems 6
Colin Application of ISO 13485 to a Medical Device distributor ISO 13485:2016 - Medical Device Quality Management Systems 5
A Setting up a Medical Device Distributor in Malaysia Other Medical Device Regulations World-Wide 17
M Austria Medical Device EU Distributor Registration EU Medical Device Regulations 2
M US FDA Medical Device Distributor Regulations US Food and Drug Administration (FDA) 6
J Size of Medical Device Distributor Logo EU Medical Device Regulations 2
G Validity for Thailand Medical Device License and can change Distributor thereafter? Other Medical Device Regulations World-Wide 3
D Medical Device Importer, Distributor, or Manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Labeling Requirements for an Implantable Medical Device Distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
T ISO 9001 for a Distributor - No Automotive or Medical ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Advice about Risk Management for a Medical Device Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
I Medical Device Distributor Requirements in the UAE Other Medical Device Regulations World-Wide 3
J Indonesia Medical Device Distributor Regulations Other Medical Device Regulations World-Wide 3
S Distributor for Products used in Medical Laboratories - Is ISO 13485 Required? ISO 13485:2016 - Medical Device Quality Management Systems 11
N Changing a Medical Device distributor in Egypt Other Medical Device Regulations World-Wide 7
G Import to Export through a Distributor - Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R 510K Requirements - Looking to be a "distributor" for a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
H Distributor Control - Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
V ISO-13485 and ISO-9001 - Medical Device Company - Distributor wants ISO9001 ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 9001 Requirements for Warehousing Data (Records) - Medical Device Distributor Records and Data - Quality, Legal and Other Evidence 3
M Are we still considered a distributor in this scenario? EU Medical Device Regulations 7
Z Distributor or importer? EU Medical Device Regulations 6
R Help Understanding Current Role; Distributor, Manufacturer, or Importer EU Medical Device Regulations 4
F MDR Distributor EU Medical Device Regulations 6
EricHeyworth Retailer obligations as distributor UK Medical Device Regulations 3
L Do non-EU based manufacturers require an importer/distributor? EU Medical Device Regulations 23
S How to deal with customers requesting documents as being in the role of distributor? EU Medical Device Regulations 5
H OTC DRUG Private Labelling Distributor: GMP REQUIREMENT ISO 13485:2016 - Medical Device Quality Management Systems 0
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 4
M MDSW Software importer distributor CE Marking (Conformité Européene) / CB Scheme 2
J Recall requirements for a distributor Medical Device and FDA Regulations and Standards News 2
JoCam Sub-distributor controls EU Medical Device Regulations 2
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1
M Procedure for communication between authorized rep and distributor Other ISO and International Standards and European Regulations 0

Similar threads

Top Bottom