SBS - the best value in QMS software

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.
 

Ajit Basrur

Staff member
Admin
#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
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 21
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
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
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
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom