SBS - The best value in QMS software

Multiple distributors in Spain

C

ccowles

#1
My US company has CE mark for our portable oxygen concentrator, Class IIa medical device.

We want to sell into Spain; I understand the AEMPS process. If we have a distributor complete this process for us, can other distributors sell the product? Or can only the registering distributor sell (exclusivity)?

Any insight would be helpful.
 
Elsmar Forum Sponsor
#2
As you are outside the EU (USA) you will need an "Authorised Representative", within the EU, who becomes the official point-of-contact for all EU authorities. The AR has certain legal responsibilities.

You can have as many distributors as you like, one (and only one) of which may also act as your Authorised Representative.

Welcome to the Cove!
 
C

ccowles

#3
Thank you for your reply.

Here is a little more clarification. We do have an EU Rep, MTP located in Germany. They said we can either have them, for a fee notify Spain of our medical device OR have a local Spanish distributor do this for us.

If we go the route of using a local distributor does that limit us to only having them sell the product? Or can others have access even though they didn't register?

Again thank you for the help!!
 
Thread starter Similar threads Forum Replies Date
K Multiple Distributors in Argentina Other Medical Device Regulations World-Wide 3
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
K Multiple function device products EU Medical Device Regulations 0
O Are power distribution units Multiple Socket Outlets (MSOs)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
I Cannot Export multiple sections from Excel to PDF without losing pagination Excel .xls Spreadsheet Templates and Tools 23
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
S Samples for GR&R - Can we get the 10 samples from multiple models Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
M Measuring Capability of Process with Multiple Specifications Capability, Accuracy and Stability - Processes, Machines, etc. 6
C FDA Registration Requirements for Multiple Sites 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
S Multiple Authorized Reps in the EU for the same device? EU Medical Device Regulations 3
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
C FMEA - Multiple function failures considerations FMEA and Control Plans 3
B AS9100 Multiple Distributor warehousing locations under same Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J DoE (Design of Experiments) - Multiple responses with different factors Using Minitab Software 2
L Control Plan - Multiple Process Steps FMEA and Control Plans 8
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
M Multiple missed POs grounds for SCAR? ISO 13485:2016 - Medical Device Quality Management Systems 32
G Single DFU for multiple medical devices in one box Other Medical Device Regulations World-Wide 0
J Brazil GMP license work with multiple BRH? Other Medical Device Regulations World-Wide 3
E Multiple socket-outlets - Medical Device Electrical Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
M IATF 16949 - Multiple Locations - 3rd party audit scope IATF 16949 - Automotive Quality Systems Standard 1
Q IATF 16949 Scope - Producing multiple products IATF 16949 - Automotive Quality Systems Standard 5
S Language of procedures when operating in multiple countries ISO 13485:2016 - Medical Device Quality Management Systems 4
A Working for multiple CB's (Certification Bodies) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
K IEC 60601-1 Testing for Multiple Socket Outlet (MSO) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
H CE Marking on Multiple-Components Medical Products EU Medical Device Regulations 8
O How to deal with Multiple Datums - Position with respect to Multiple Datum Feature Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
P Multiple Certifications - Is there an order of precedence? Other ISO and International Standards and European Regulations 3
M FDA UDI with Multiple Packaging Configurations Other US Medical Device Regulations 3
G Gage R&R Across Multiple Sites in a Company Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
3 Egypt: Multiple Registrations of the Same Product Other Medical Device Regulations World-Wide 2
3 Multiple registrations / authorized representatives in Iran Other Medical Device Regulations World-Wide 4
R Excel Dashboard for Health Safety and Environmental KPI's for Multiple Sites Occupational Health & Safety Management Standards 4
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
3 Russia - 1 Registration with Multiple Trade Names Other Medical Device Regulations World-Wide 3
D Multiple Features With Only One Toleranced on the Print Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12

Similar threads

Top Bottom