Roles of Manufacturer vs. Importer vs. Distributor

#1
Could someone point me in the right direction? I am looking to understand the roles of manufacturer, importer, distributor.

Thanks in advance!

Bradford
 
Elsmar Forum Sponsor

Asherlee

Involved - Posts
#3
HI,
Look at Article 2 of the MDR for the definition of an importer, distributor, etc. The attached table summarizes the responsibilities of each entity and shows where you can find more info. on this in other Articles in the MDR.

Regards

Asherlee
 

Attachments

Ronen E

Problem Solver
Staff member
Moderator
#4
HI,
Look at Article 2 of the MDR for the definition of an importer, distributor, etc. The attached table summarizes the responsibilities of each entity and shows where you can find more info. on this in other Articles in the MDR.

Regards

Asherlee
I'm not sure we are discussing a medical device.
 
Thread starter Similar threads Forum Replies Date
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Roles and accountabilities procedure? ISO 13485:2016 - Medical Device Quality Management Systems 9
N ISO 9001:2015 - 5.3 - The roles and responsibilities matrix rears it's head ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Defined Roles in Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J What does "other relevant management roles" include? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I ISO 17025 Job Descriptions - People who have mutiple roles ISO 17025 related Discussions 2
N Roles and Responsibilities with Suppliers for NC Parts Quality Manager and Management Related Issues 5
J How to decide work-stream in scope of Quality - Roles and Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
R Training - Relating Job Roles to Specific Procedures Training - Internal, External, Online and Distance Learning 3
X Are defined roles and responsibilities mandatory for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Has anyone done both Quality and Facility Security Officer (FSO) roles ? Career and Occupation Discussions 8
L Quality Mgr vs Business Development Admin. - Roles and Responsibilities Misc. Quality Assurance and Business Systems Related Topics 2
D Director vs. Manager - Roles in RA in a Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 5
T Senior SQE (Supplier Quality Engineer) Specific Roles and Responsibilities Career and Occupation Discussions 5
Q Is an actual document for Roles and Responsibilities necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M What are typical Roles & Responsibilities of DHF (Design History File) Librarian? US Food and Drug Administration (FDA) 6
A ISO 9001 Required Roles and Responsibilities? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Small Company Organizational Chart with many Shared Roles Quality Manager and Management Related Issues 10
J Quality Systems Coordinator vs. Management Representatve - Responsibilities and Roles ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
R Roles and Responsibilities for new Documentation and Compliance team Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
V What are the roles and responsibilities of quality system engineers? General Auditing Discussions 1
Ajit Basrur Roles and Responsibilities - Quality Manager, Lab Manager and Technical Manager ? General Measurement Device and Calibration Topics 5
T Small Engineering Company Certification - Are Diverse Roles permitted? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Roles and Responsibilities of EMS Coordinator plus more Miscellaneous Environmental Standards and EMS Related Discussions 5
G ISO 9001:2000 Organizational Roles & Responsibilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Covering Quality Manager/QMR JD (Job Description) with QMR Roles in Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q Management Representative vs. Deputy MR in terms of roles and responsibilities? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
L Roles as QC Exec & Quality Courses recommendation Career and Occupation Discussions 4
G Supplier Quality Assurance Roles and Responsibilities Supplier Quality Assurance and other Supplier Issues 8
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 0
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 Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
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
Similar threads


















































Top Bottom