Choose Medical Device Distributors prior to Device Registration?

JoCam

Trusted Information Resource
#1
Hi Guys,

I hope you can help.

My company, based in the UK, hold a CE mark for a class IIb medical device. I am putting together a report detailing the requirements for registration of this device in Japan, China, Russia, South Korea, Brazil and Canada and would like to know whether I need to have chosen a Distributor/Importer for each of these countries BEFORE I can fill out the application forms for registration, or can these be selected once registration has been awarded.

Your help will be very much appreciated.

Thank you in advance,

Jo
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I believe in all of those countries other than Canada, the registration or equivalent process must be undertaken by a party that is located within the subject country. This might be your distributor, or a third party registration agent, or your own in-country affiliate office if such exists.

This consideration might be related to your question, depending on how you approach it.
 

JoCam

Trusted Information Resource
#3
Thank you Miregmgr, but I think I need to rephrase the question:

If you choose not to use a Distributor to register your product in these countries and utilise the services of a local agent who does not distribute product, would you have to declare on the application form who your eventual Distributor is going to be, or can you select them after you've been registered.
 
M

MIREGMGR

#4
My understanding is that in Japan, Canada and Brazil, a distributor does not have to be declared at time of registration. We have a China registration that did include declaration of a distributor, but I don't think that was mandatory. Korea, I think, does require declaration of a distributor/importer. I don't know the answer to this question for Russia.
 
M

MPiska

#6
In all cases excluding Korea and Canada, I have had to declare the importer/distributor.

For Brazil registration the importer must appear on your proudct and packaging labelling and this is approved through ANVISA during the registration process.

I can't 100% answer for Russia, as we are using a distirbutor as the registration agent however our registration (been in progress since June 2013 and changed several times) has included the declaration of the importer/distributor since the start.

For China you have to declare the intended legal agent, after service agent and distribution authorisation, and any changes to this after the fact are notifiable to the CFDA. Again, our current registration is through a distributor, who will own the registration afterwards and you will need their authorisation to change any details. If you register via a consultancy or dedicated legal agent, you may not have any issues in changing these details afterwards.
 
M

MIREGMGR

#7
For Brazil our experience was somewhat different, in that the importer and distributor are different parties. Thus yes, we also had to identify the importer to ANVISA, but there was no identification of that importer on the labeling, and the distributor was not identified to ANVISA.

We got approval for a family of products through a third party agent, acting as our in-country Brazil Registration Holder (BRH) who declared themselves to be the importer of record. We didn't yet know at that time who would be the eventual distributor(s). The BRH didn't declare themselves to be the distributor, as that would have been non-factual.
 
Thread starter Similar threads Forum Replies Date
D How to choose an EU Authorized Representative for a Medical Device CE Marking (Conformité Européene) / CB Scheme 3
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
A Taguchi Minitab - Continuous Data - What should I choose as response variable? Using Minitab Software 3
R Which Notified Body to Choose in the EU EU Medical Device Regulations 7
P New Part - How to choose what needs GRR (Gage R&R) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
A Inspection Plans - How to choose AQL (MIL STD 105E) Excel .xls Spreadsheet Templates and Tools 1
S Which Torque Meter do I choose based on CpK studies ? Capability, Accuracy and Stability - Processes, Machines, etc. 2
M How to Choose the Best Document Control Software Quality Assurance and Compliance Software Tools and Solutions 14
A Which Certification Body (CB) to Choose Registrars and Notified Bodies 6
G Hey Auditors, When do you choose to fly? Internal Auditing 10
C Can we choose to not allow auditor back on site? Conflict of Interest? Supplier Quality Assurance and other Supplier Issues 11
B What Measurement Tool to Choose for Plastic and Metal Parts Measurement Uncertainty (MU) 3
Z Interviewing an External Auditor? Choose a Registrar for ISO 9001 Registration Registrars and Notified Bodies 30
H Which OHSMS standard to choose? ILO? ANSI? CSA? BS? OHSAS? Occupational Health & Safety Management Standards 15
ScottK How to choose professional references when applying for a job? Career and Occupation Discussions 1
R How to choose constants when sample size larger than 25? Statistical Analysis Tools, Techniques and SPC 7
S MIL-STD-1916 vs MIL-STD-105E, which do you choose? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
W How to choose the correct General Inspection Level & AQL level...? AQL - Acceptable Quality Level 5
M Bevel Protractor - Which one to choose? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M How many parts do I choose for an MSA (Measurement System Analysis)? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
T Can we pick and choose areas of operation to claim ISO9001 Compliance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Marc Free Streaming Music - Choose the songs you want After Work and Weekend Discussion Topics 8
A VSM - Should I sum up the inventory? Which C/T to choose? Lean in Manufacturing and Service Industries 3
T Internal Auditing - ISO 9001 auditing vs. FDA CFR auditing - Which to choose? ISO 13485:2016 - Medical Device Quality Management Systems 5
K Which CB (registrar) to choose for ISO 9001 registration?? Registrars and Notified Bodies 11
samer How to choose the right Certification Body (Registrar)? Registrars and Notified Bodies 33
SteelMaiden Which Safety Registration Program to Choose? OHSAS 18001? Z10? Various Other Specifications, Standards, and related Requirements 36
D How to choose Samples for a Gage R&R (GR&R) study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 25
C Why did you not choose mechanical engineering? Interview Question Career and Occupation Discussions 6
C Career Change Question - Why did you choose Quality Engineer as starting job? Career and Occupation Discussions 3
R How to choose samples for Gage R&R - Micrometer to check tube thickness Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
L Useful Foreign Languages - Which 'foreign' language would you choose? Career and Occupation Discussions 54
H Company Wants To Pick and Choose what Customers to apply the QMS to ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Is there any Criteria to choose samples for R&R study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A You can only choose one Rock n' Roll album to save Coffee Break and Water Cooler Discussions 46
J How To Choose A Good Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 3
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules --Manufacturing and Whole sale Lic. Required ? Other Medical Device Regulations World-Wide 0
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1

Similar threads

Top Bottom