Local Agent and Sales Rights in countries like Brazil and Russia

Y

youuu

#1
Hello,

I am working at Class 2 medical device manufacturing company.
I'm concerned with countries like Brazil and Russia where device registration is linked to that specific device sales right.
Currently in Brazil, I have a local agent which is not a consulting company and they sell medical device themselves too.. anyhow they also serve as our distributor.
We are in progress for achieving ANVISA and I understand that if our company and our agent (also distributor) obtain certification, our agent/distributor has the right to sell regarding that certification.

So here is my question:
Can I proceed with a different independent agent to obtain new certification from ANVISA with same device (and same model name) and also sell through a different sales path other than my existing agent/distributor?

+please also explain about the sales right issue in Russia if anyone have information.

I apologize in advance if there was any existing thread regarding this issue.
I tried to read through some threads but I couldn't find any..

:thanx:
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#3
Can I proceed with a different independent agent to obtain new certification from ANVISA with same device (and same model name) and also sell through a different sales path other than my existing agent/distributor?
]

Yes, you only need to have a different CNPJ and a separate contract.
 
Thread starter Similar threads Forum Replies Date
D Local Authorized Representative - Kenya Other Medical Device and Orthopedic Related Topics 1
G App - Local regulations applicable EU Medical Device Regulations 2
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
R Do we need to treat local law as external origin documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Invalid ISO Standard / Guidelines - ISO 22301 BCMS and a local standard Various Other Specifications, Standards, and related Requirements 1
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
H Local Representative / Distributors - United Arab Emirates Other Medical Device Regulations World-Wide 2
S Internal Audits performed by another local business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
qualprod Minor non-conformance for not controlling local regulation laws? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
K Our local sterilizer is closing - Record Retention Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
qualprod Which standard to follow, local or international? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Malaysia - Full Labelling Local Language Translation Other Medical Device Regulations World-Wide 1
B Global / Local Management Review - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
F Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
P Looking for a company local in Wyandotte, Mi, to come in check noise levels Manufacturing and Related Processes 2
L Find Local Authorized Representative (LAR) for medical device EU Medical Device Regulations 5
S Internal Audits of QMS Corporate Basics at the Local Plant Level ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H PPAP for a US$2 Part Purchased from a local Distributor APQP and PPAP 3
Marc The Fastest Broadband In The US Is Being Built by Local Communities After Work and Weekend Discussion Topics 2
E Automotive: Local Content Suppliers in Morocco, Thailand, Brazil, and India Misc. Quality Assurance and Business Systems Related Topics 2
S IVD Device Registration in France by our local AR EU Medical Device Regulations 5
G Corporate Documents cover local facility - How many departments can I exempt? Document Control Systems, Procedures, Forms and Templates 3
J Requirements for marketing collateral translation into local languages in Europe? EU Medical Device Regulations 3
Crusader Local Control Document procedure....define it or not? Document Control Systems, Procedures, Forms and Templates 24
S Locating a quality local AS9100 rev C system consultant AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Local Processes under umbrella of a Global QMS Quality Manager and Management Related Issues 5
T Local Distributor and/or Local Registration for Medical Devices Required? Other Medical Device Regulations World-Wide 2
S Validity of Craig Hane's Global Local Index for X-bar R Chart Assessment Capability, Accuracy and Stability - Processes, Machines, etc. 3
H Visual Aids - Documentation in our Specification System or Local Control? Document Control Systems, Procedures, Forms and Templates 2
P Terrible Storm - Typhoon Ketsana (local name Ondoy) Coffee Break and Water Cooler Discussions 3
J Non Local Job Search Career and Occupation Discussions 4
B What local standards are needed for ISO 9001 - Automatic doors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Peter Fraser Our local box office's habit of adding a "booking fee" Customer Complaints 14
A ISO 9001 in local public administration - A city hall ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
C LEPC (Local Emergency Planning Committees) Required under our RC14001 (EHS&S) Miscellaneous Environmental Standards and EMS Related Discussions 2
J ISO 9000 vs. AS9100 in a Local Fabrication and Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
ScottK Local Community Message Board - Big Brother? Coffee Break and Water Cooler Discussions 18
C Are CQE refresher courses by local ASQ centers helpful in preparing for the exam? Professional Certifications and Degrees 11
P Liability Insurance for local consulting jobs Consultants and Consulting 6
F Quality Management System vs. Effects of Local Culture on Implementing a QMS Misc. Quality Assurance and Business Systems Related Topics 22
Marc Your Local World Wide Weather - April 2006 to October 2006 Coffee Break and Water Cooler Discussions 33
Marc Your Local World Wide Weather - December - 2005 to April 2006 Coffee Break and Water Cooler Discussions 80
Jen Kirley Going to my local chapter's annual planning meeting ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
Sidney Vianna ISO 9001:2000 guidelines for local government ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
G Can Work Instructions be audited? 'Local' vs. Corporate policies and procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Marc Your Local World Wide Weather - November - 2004 to April 2005 Coffee Break and Water Cooler Discussions 46
R Lean Training Class Exercise - Working with a local college on training materials Lean in Manufacturing and Service Industries 2
D Definition Procedure vs. Guidelines (Like local work instructions) - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 48
M Optimization vs. Local Suboptimization Philosophy, Gurus, Innovation and Evolution 30

Similar threads

Top Bottom