What regulations must a distributor follow when submitting PPAPs?

A

amiller

#1
What regulations must a distributor follow when submitting PPAPs from a supplier to a customer? Are they the same as the ones governing a regular supplier even though the production is not being done by the distributor?
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
I don't know that there are any rules defined anywhere. My experience has been the customer SQA tells you what they want.
 
Thread starter Similar threads Forum Replies Date
N How to validate Regulations and Standards? ISO 13485:2016 - Medical Device Quality Management Systems 12
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 1
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 Competitor not complying with regulations (EU) EU Medical Device Regulations 1
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
V Regulations renewal IATF 16949 - Automotive Quality Systems Standard 1
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Draft of New UK Regulations? UK Medical Device Regulations 2
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
T Conflict Mineral Regulations Reliability Analysis - Predictions, Testing and Standards 1
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
G App - Local regulations applicable EU Medical Device Regulations 2
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
Q Regulations for Medical Device Kit for Training Personnel? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 4
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
L Staying up to date on Regulations Other Medical Device Regulations World-Wide 8
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
S Mammography standards or regulations for radiology software (no hardware)? Other Medical Device and Orthopedic Related Topics 0
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
M Informational Commission Regulation (EU) 2019/319 of 6 February 2019 amending previous regulations as regards health certification at import into the Union concerni Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
M End of Life or Device transfer regulations for Legal Manufacturer Other Medical Device Regulations World-Wide 1
F Assignment of Special Characteristics to government regulations IATF 16949 - Automotive Quality Systems Standard 5
D Documentation requirements for the new Medical Device Regulations (2019) CE Marking (Conformité Européene) / CB Scheme 5
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4

Similar threads

Top Bottom