Does supplier with manufacturing in US for EU market need Establishment Registration?

SGquality

Quite Involved in Discussions
#1
If the manufactuer manufactures medical devices that are 100 % exported for EU market need to have an "Establishment Registration" with US FDA ?
 
Elsmar Forum Sponsor

liuyy

Involved In Discussions
#2
Re: Does supplier with manufacturing in US for EU market need Establishment Registrat

Yes!Both registration and listing r needed.
 
#3
Re: Does supplier with manufacturing in US for EU market need Establishment Registrat

If the manufactuer manufactures medical devices that are 100 % exported for EU market need to have an "Establishment Registration" with US FDA ?
Yes this category falls under "U. S. manufacturer of export only devices" (Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries) need both Establishment Registration and Device Listing.

Refer http://www.fda.gov/MedicalDevices/D...egistrationandListing/ucm053165.htm#exportmfg
 
Thread starter Similar threads Forum Replies Date
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
Q Does our material suppliers’ supplier have to be at least ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 3
T Does nonconforming product disposition include parts bought from the supplier? IATF 16949 - Automotive Quality Systems Standard 15
M Does 21 CFR 820.80 (b) require a Supplier to have Receiving Inspection? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
L Does someone has experience with a Supplier "Quality Watch" Supplier Quality Assurance and other Supplier Issues 3
K Does ISO 9001 require Supplier Pre-Qualification? Supplier Quality Assurance and other Supplier Issues 27
V AS9100 and AS9102 - Does our supplier have to do the FAI using the 3 AS9102 forms? Document Control Systems, Procedures, Forms and Templates 3
C Does anyone have the Ford Supplier Requirements Manual (including Q1)? Customer and Company Specific Requirements 2
J Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G Does AS9100 require approving your Customer as a Supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
I Where does it state Supplier Corrective Action is required? Supplier Quality Assurance and other Supplier Issues 5
P Supplier's Property - Does 7.5.4 Customer property apply to supplier's property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
M The Customer does not Audit to their own Supplier Quality Manual General Auditing Discussions 16
D Which supplier does clause TS 16949 clause 7.4 refer to? IATF 16949 - Automotive Quality Systems Standard 5
M Aftermarket and Big Three Supplier - How does this affect the quality system? IATF 16949 - Automotive Quality Systems Standard 3
I AQL - Does AQL relate to the Six Sigma capability of my supplier? AQL - Acceptable Quality Level 7
P Toyota Supplier Requirements - Does anyone have the Toyota SQAM? Customer and Company Specific Requirements 19
C C=O puzzle - What protection does C=0 provide a supplier? Statistical Analysis Tools, Techniques and SPC 15
Q SCAR Form - Does anyone have an example of a Supplier Corrective Action form? Supplier Quality Assurance and other Supplier Issues 1
Manix Does anyone know if BMW has a web based Supplier Portal? Customer and Company Specific Requirements 3
A Supplier 8D does not stop the problem - Critical defects - How to make 8D effective? Supplier Quality Assurance and other Supplier Issues 4
S Supplier Scorecard - Does anyone have an example Supplier Scorecard? Supplier Quality Assurance and other Supplier Issues 27
M Does a Raw Material Supplier Change Require PPAP? APQP and PPAP 23
I Does anyone have any advice for a TE supplier in regards to TS16949? Supplier Quality Assurance and other Supplier Issues 2
K TS16949 & Supplier Development - To which suppliers does this requirement apply? Supplier Quality Assurance and other Supplier Issues 11
B Does TUS require load thermocouples? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
G When does containment event not require 100% sort? Nonconformance and Corrective Action 5
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
N FPY requested for an industry that does not have rework IATF 16949 - Automotive Quality Systems Standard 4
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
Ajit Basrur Does "Refurbishment" fall under "Service"? ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom