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

Hunkered Down for the Duration
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
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 9
M The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 0
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
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 2
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
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
J What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations? Other Medical Device Regulations World-Wide 2
S China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices China Medical Device Regulations 1
V Class IV Laser Regulations IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
F What directives/regulations apply to Analyte Specific Reagents (ASRs) in EU EU Medical Device Regulations 0
K Moist Heat Sterilization worldwide Requirements and Regulations Other Medical Device Regulations World-Wide 1
M Medical Device Regulations in African Countries Other Medical Device Regulations World-Wide 0
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Applicable Medical Device Wifi regulations for various Countries Other Medical Device Regulations World-Wide 7
J FDA regulations vs. IEC 60601-1 Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
C "Fast action" claim and MDR (Medical Device Regulations) EU Medical Device Regulations 8
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
E Doubts about the FCC regulations for the use of Bluetooth in medical equipment Other Medical Device Related Standards 3
H EU Medical Device Regulations (MDR) Checklist EU Medical Device Regulations 1

Similar threads

Top Bottom