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
A Ever registered a device in one of the countries below? Any recommendations on local representatives or consultants would be great! Other Medical Device and Orthopedic Related Topics 0
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
Q EU Local Language Requirements for Operator Or User Manuals CE Marking (Conformité Européene) / CB Scheme 1
A Outsourcing registration to a local company China Medical Device Regulations 1
M Addition of IFU on local language by distributor - Article 16? EU Medical Device Regulations 1
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
D Local Authorized Representative - Kenya Other Medical Device and Orthopedic Related Topics 3
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

Similar threads

Top Bottom