Distributor Control - Medical Device Manufacturer

H

hitesh

#1
Hi,

We are medical device manufacturer. We have major distributors in USA and Europe. We would like to ensure that we are covering all necessary items in the distribution contract. I am looking for distribution contract sample or items that must covered in the contract to comply with FDA, European and Canadian Regulatory requirements for manufcturer.

Sincerely,
Hitesh
 
Elsmar Forum Sponsor
K

krishna007

#3
Hi Hitesh

I am very much interested in this topic, at this moment, as we are dealing with the same question but on the other side of the coin.

Some aspects that we have identified are -

What does a manufacturer want from a distributor.
Who is providing service to the customer
who would be responsible for med de reporting
How is the distributor accomodate the complaint handling procedure.
What shall the distributor do for record keeping - invoices, purchase orders, customer info.
etc...

other points in addtion to these and/or corrections for the same are appreciated.

Regards

krishna
 
G

gabo1

#4
Hi,

Beside the strictly commercial activity you want from the distributor, as promotion, sale, sub-distribution, use of brands, and so on, here is some point that I would take into account:

- Storage and handling of devices (environmental conditions, transportation terms, management expiring products)
- Traceability (define at least what should be tracked, records keeping)
- Management of materials returned by customers
- Availability to be audited (the distributor by the manufacturer and by the Regulatory Authorities, or....the manufacturer by the distributor)
- Training activities - for example: "the DISTRIBUTOR shall train customers for the techniques of devices proper use (surgical techniques, transparencies, instructions for use)
- Complaint handling
- Vigilance activities (as for European requirements the suggestion is to make reference to MEDDEV 2.12.1 document)

Regards,

Gabo1
 

chris1price

Trusted Information Resource
#5
These lists are great and cover most or all the elements that should be in a contract or agreement. However we cannot say who does what function. It depends on the nature of the manufacturer and the distributor and what resources are available to each.

Whatever is decided, it should be well documented and agreed by both parties. But the manufacturer should remember that they are ultimately responsible for the work, and if they do pass some of it to the distributor, they should audit the distributor to ensure it is being done correctly

Chris
 
Thread starter Similar threads Forum Replies Date
O ISO 9001:2015 - 8.4 Control of externally provided-Distributor & drop shipments.... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H Design Control Requirement - Initial Distributor of a Class I Video Laryngoscope US Food and Drug Administration (FDA) 4
U Distributor obligations under MDR EU Medical Device Regulations 1
K Penalty to MD distributor or manufacturer? CE Marking (Conformité Européene) / CB Scheme 3
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Reporting REACH - Electronic components distributor REACH and RoHS Conversations 5
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Packaging in Distributor Practices EU Medical Device Regulations 0
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
XRAY_3121 New Job with Wholesale Distributor Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Combination Products - Distributor of the device? EU Medical Device Regulations 7
Y Distributor for a SaMD Medical Information Technology, Medical Software and Health Informatics 3
Q MDD - distributor EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
P Economic operator responsibilities - when the Importer is also Distributor - Article 13 EU Medical Device Regulations 1
L Global distributor vigilance responsibility Medical Device and FDA Regulations and Standards News 14
T Translation of IFUs and software by Distributor EU Medical Device Regulations 1
S When does a Distributor become a Specification Developer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D CB Certificate - Distributor for a product with electrical components CE Marking (Conformité Européene) / CB Scheme 4
B Roles of Manufacturer vs. Importer vs. Distributor CE Marking (Conformité Européene) / CB Scheme 3
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 14
K Obligation for Distributor in MDD/MDR CE Marking (Conformité Européene) / CB Scheme 4
B AS9100 Multiple Distributor warehousing locations under same Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
BLoganB UDI for former manufacturer - My company is a distributor Other US Medical Device Regulations 0
D Use of non-ISO 9001 Supplier - Purchasing through a distributor IATF 16949 - Automotive Quality Systems Standard 7
K Selling Medical Devices in Canada - Distributor? Private Label? Canada Medical Device Regulations 10
M 13485- DHR requirement for a distributor? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Are zero defect sampling plans relevant to AS9120B Distributor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Sampling method that is representative of the devices supplied by that distributor EU Medical Device Regulations 5
supadrai Countries where you should (absolutely?) avoid appointing a distributor ... Other Medical Device Regulations World-Wide 6
A NCR, NCMR, CAPA, Deviations - Medical Device Distributor Nonconformance and Corrective Action 2
M Manufacturer - Distributor (Importer) Relationships Other US Medical Device Regulations 2
P Customer Complaint Definition - Food Distributor Customer Complaints 5
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
V Inspection of Initial Importer/ Distributor Products and Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L PSW Requirements for a Distributor APQP and PPAP 1
F Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
D Distributor of Medical Devices - Is ISO certification required? ISO 13485:2016 - Medical Device Quality Management Systems 1
pittmatj Sri Lanka - Agent/Distributor owns registration? 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 2
Colin Application of ISO 13485 to a Medical Device distributor ISO 13485:2016 - Medical Device Quality Management Systems 5
M Raw Material - List Distributor or Manufacturer US Food and Drug Administration (FDA) 1
A Setting up a Medical Device Distributor in Malaysia Other Medical Device Regulations World-Wide 16
M Austria Medical Device EU Distributor Registration EU Medical Device Regulations 2
S Korean Licence Holder - Importer - Distributor Other Medical Device Regulations World-Wide 2
S Resterilization of Disposable Medical Devices by a Distributor Other Medical Device and Orthopedic Related Topics 5

Similar threads

Top Bottom