SBS - The best value in QMS software

Taiwan Medical Device registration - Production or legal office

B

bisbita

#1
The information that I am looking for has not been published or maybe I could not find it. I really hope you to help me. It is related to Medical devices.

The manufacturer has two addresses, one is where they make the product, and the other one is where they have their legal office. Both are placed in different cities. (in that case same country)

And my question is: do they have, these two addresses, to appear in the product registration? Or just one would be fine?

thank you so much guys
 
Last edited by a moderator:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: MD registration Taiwan - production or legal office

Which registration are you referring to?
 
B

bisbita

#5
we are based in Europe, Italy. We had some others problems with other registrations in Asia. In some certifications we have two addresses, the legal office and the production office... that is why..
 

Ronen E

Problem Solver
Staff member
Moderator
#6
we are based in Europe, Italy. We had some others problems with other registrations in Asia. In some certifications we have two addresses, the legal office and the production office... that is why..
I'm sorry, but I'm still not able to understand what certifications / registrations exactly you refer to. Is it ISO 13485?
 
B

bisbita

#7
well.. my question were more general, but, yes, the ISO 13485 is one of the main points. also, for Free sales certificates or powers of attorney.

Did I say thank you?

Thanks mate
 
Thread starter Similar threads Forum Replies Date
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
J What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations? Other Medical Device Regulations World-Wide 3
C Medical Device Registration Process in Taiwan Other Medical Device Regulations World-Wide 6
T Taiwan Medical Device Importation Other Medical Device Regulations World-Wide 5
E Taiwan Medical Device Adverse Event Reporting Other Medical Device Regulations World-Wide 6
I Taiwan Medical Device Product Approval Process using a Subcontractor Other Medical Device Related Standards 10
C Registration Process for Medical Devices in Taiwan Other Medical Device Regulations World-Wide 11
S Taiwan GCP for Medical Devices in English Various Other Specifications, Standards, and related Requirements 1
U Intended use - Taiwan EU Medical Device Regulations 2
F Guidance in English for PMS requirements for Taiwan Other Medical Device Regulations World-Wide 2
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
I Vigilance SOP that covers Australia, Taiwan, Japan or Brazil wanted Other Medical Device Regulations World-Wide 1
Q Certified Six Sigma Green Belt Training-Taiwan Professional Certifications and Degrees 8
K Does anyone know any CMM resellers in Taiwan? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Ajit Basrur Internet connections snapped - The Taiwan earthquake Coffee Break and Water Cooler Discussions 5
apestate Seeking Information about Working in Taiwan Career and Occupation Discussions 2
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 7
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
N Medical device name in different countries EU Medical Device Regulations 4
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 1
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom