Class 3 Device - Change of supplier of material

D

DH1981

Starting to get Involved
#1
#1
What sort of notification is requried for change in to a material supplier?
If we bring the manufacturing of that particular component in-house and the formulation and release specs are exactly the same does this consititute a significant change?
The only difference will be the part number. Is an update to the License required?
Thank you.
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
D

DH1981

Starting to get Involved
#2
#2
What sort of notification is requried for change in to a material supplier?
If we bring the manufacturing of that particular component in-house and the formulation and release specs are exactly the same does this consititute a significant change?
The only difference will be the part number. Is and notification to FDA requried?
Thank you.
 
D

DH1981

Starting to get Involved
#4
#4
What sort of notification is requried for change in to a material supplier?
If we bring the manufacturing of that particular component in-house and the formulation and release specs are exactly the same does this consititute a significant change?
The only difference will be the part number. Is and notification to FDA requried?
Thank you.
 
William55401

William55401

Involved In Discussions
#5
#5
Please share more. What is the device? What is the intended use? What is the component's role (with the change in material or material processing from buy to make) in the device?
 
R

RA Guy

Involved In Discussions
#7
#7
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Change to Outer Packaging Material/Supplier - Sterile, Class IV Device Other Medical Device Related Standards 4
B Class II and Class III Medical Device Amendment for Change in Location? Canada Medical Device Regulations 2
T Class II Medical Device with Software - Change to Computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Class IIa Medical Device - Can I over label to change an address? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Change Medical Device Class from Class II to Class I 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Class I Medical Device - 1st notification and change notification EU Medical Device Regulations 4
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
S Shipment of a CE Approved Class III Device to the EU Member States Other US Medical Device Regulations 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
Y Retrospective Validation - Class I device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S How to register class IIA medical device accessories EU Medical Device Regulations 1
U Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden Other Medical Device and Orthopedic Related Topics 2
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
B Label Review for Class II Device US Food and Drug Administration (FDA) 0
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
B Class III Medical Device Accelerated conditions Other Medical Device Related Standards 1
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
M Predicate device - Search for a Class IIa device US Food and Drug Administration (FDA) 2
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
D Class II medical device - When should a complaint be closed? Customer Complaints 6
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
S Acrylic in Class II b Active Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
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
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
K Inventory Control - Class II (IIb for CE) medical device ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom