Manufacturer - Distributor (Importer) Relationships

Mark Meer

Trusted Information Resource
#1
I could use some clarification as to the specific responsibilities of (foreign) Manufacturers and local distributors (importers). Specifically with respect to MDR (21 CFR 803) and complaint handling (21 CFR 820.198).

A couple initial questions to help me better understand:

First:
Can the distributor (importer) take on all these responsibilities? If they wanted to, can they register as "Manufacturer", and then assume these responsibilities, even though technically, all they do is import and distribute. My gut says no, but this arrangement is being entertained here...

Second:
The MDR regulations consistently use the language "If you are a manufacturer or importer..." (emph. added). This does not make clear who is responsible. How are the responsibilities established? Through private contract agreements, or is there some mechanism to establish responsibilities through the FDA?

Any input/clarification, or links to relevant guidances would be much appreciated!
Thanks in advance!
MM.
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
I could use some clarification as to the specific responsibilities of (foreign) Manufacturers and local distributors (importers). Specifically with respect to MDR (21 CFR 803) and complaint handling (21 CFR 820.198).

A couple initial questions to help me better understand:

First:
Can the distributor (importer) take on all these responsibilities? If they wanted to, can they register as "Manufacturer", and then assume these responsibilities, even though technically, all they do is import and distribute. My gut says no, but this arrangement is being entertained here...

Second:
The MDR regulations consistently use the language "If you are a manufacturer or importer..." (emph. added). This does not make clear who is responsible. How are the responsibilities established? Through private contract agreements, or is there some mechanism to establish responsibilities through the FDA?

Any input/clarification, or links to relevant guidances would be much appreciated!
Thanks in advance!
MM.
Hi Mark,

From what I'm reading in these regs, the only ways your distributor can claim manufacturer status are: 1) They repackage or change the container, wrapper, or labeling of a device; or 2) They are the U.S. agent of a foreign manufacturer. Sounds pretty clear when you look at the definitions found in 21 CFR 803.3(e)(j)(l).

Perhaps others have a different interpretation and will share their thoughts.

Just curious, but why does your distributor (importer) want to take on these responsibilities?
 

Mark Meer

Trusted Information Resource
#3
From what I'm reading in these regs, the only ways your distributor can claim manufacturer status are: 1) They repackage or change the container, wrapper, or labeling of a device; or 2) They are the U.S. agent of a foreign manufacturer. Sounds pretty clear when you look at the definitions found in 21 CFR 803.3(e)(j)(l).
That is my reading as well, also by the Definitions of Establishment Activities.

It appears that they could act in the capacity of parts 803 (reporting) and 806 (corrections and removals), as these regulations use the "...manufacturer or importer..." language I was inquiring about in the original post - still not sure how the responsibilities are formally established in practice, however. We've just, up until now, always assumed these responsibilities as the manufacturer.

Complaint-handling, however, is clearly the responsibility of the manufacturer, as per 820.198.

Perhaps others have a different interpretation and will share their thoughts.
Hope so... (nudge, nudge) ;) :notme:

Just curious, but why does your distributor (importer) want to take on these responsibilities?
Not sure. Maybe they've just got a well integrated system, and standard agreement with all partner manufacturers? ...but if they want to alleviate responsibilities from us, I'm fine with that, as long as it's done by the book and we're complying with regulations. (hence my original post)
 
Thread starter Similar threads Forum Replies Date
B Roles of Manufacturer vs. Importer vs. Distributor CE Marking (Conformité Européene) / CB Scheme 3
D Medical Device Importer, Distributor, or Manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
bio_subbu GHTF definition of Manufacturer, Authorized Representative, Distributor and Importer Other Medical Device and Orthopedic Related Topics 2
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
BLoganB UDI for former manufacturer - My company is a distributor Other US Medical Device Regulations 0
M Raw Material - List Distributor or Manufacturer US Food and Drug Administration (FDA) 1
L Supplier Selection and Evaluation - Raw Material Manufacturer vs. Distributor ISO 13485:2016 - Medical Device Quality Management Systems 3
M Manufacturer's handling of Distributor's Historical Complaint Records US Food and Drug Administration (FDA) 5
N One Company, Split into two - Part Manufacturer, Part Distributor? QMS Adjustments? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W Definition of Manufacturer, Sponsor, Distributor in Australia Therapeutic Goods Act Other Medical Device Regulations World-Wide 19
T From Manufacturer to Distributor - Still keep ISO 9001:2008 Certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Purchasing contract clauses -spec developer/contract manufacturer/initial distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Distributor Control - Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
Douglas E. Purdy Scope of QMS for Distributor VS. Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2
A Can a US manufacturer put export only products on a CFG? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
K Legal manufacturer vs Actual manufacturer EU Medical Device Regulations 4
U CFS and Legeal manufacturer EU Medical Device Regulations 6
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K 510K new manufacturer but same components Other US Medical Device Regulations 6
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
Q Legal Manufacturer OTC Drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4
N Updating the website of the manufacturer EU Medical Device Regulations 1
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
J Complaints and not the legal manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
D Are we the manufacturer or relabeler? Medical Device and FDA Regulations and Standards News 2
M Manufacturer address on the label Other US Medical Device Regulations 18
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4
D Manufacturer's agreement with their EU Authorized Representative EU Medical Device Regulations 3
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
A OEM branding - My interpretation of the LVD Directive makes us a manufacturer CE Marking (Conformité Européene) / CB Scheme 3

Similar threads

Top Bottom