Is there a MDR (Medical Device Reporting) equivalent in China ?

B

BJMQA

#1
Does the CFDA have the equivalent of a MDR? We have a customer, based in China, who only sells in China, and has reported a defect back to us. We are US based. The defect could lead to extended surgery times if encountered and not detected prior to surgery. By FDA's definition this is a reportable event, but I can not find device regulations, in english, which call out the requirements for reporting this to the CFDA. Also, our customer said they are not filing this as a complaint because the complainant did not file an official complaint. Is this how a complaint should be handled in China? Any help is much appreciated.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Breast Pump under MDR classified as medical device? EU Medical Device Regulations 9
E Under MDR is a medical workstation a medical device or an accessory? EU Medical Device Regulations 5
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
E How is my medical device sofware classified under MDR? EU Medical Device Regulations 2
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 6
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
M New medical device on the market before MDR EU Medical Device Regulations 12
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 10
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
C "Fast action" claim and MDR (Medical Device Regulations) EU Medical Device Regulations 8
H EU Medical Device Regulations (MDR) Checklist EU Medical Device Regulations 1
C Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations Other Medical Device Regulations World-Wide 2
S MDR (Medical Device Regulations 2017/745) training recommendation for Auditors EU Medical Device Regulations 1
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 9
N New MDR EU Medical Device/IVD Regulations - Definition of Importer EU Medical Device Regulations 1
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
E Amendment to Medical Device Directive (MDR) - December 2013 EU Medical Device Regulations 0
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
R First MDR (Medical Device Report) - Does the FDA give feedback? US Food and Drug Administration (FDA) 4
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
R MDR (Medical Device Report) Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Medical Device Vigilance - MDR or MDD? EU Medical Device Regulations 9
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
M MDR Medical devices Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
Q MDR Effectivity date for Legacy Class I Medical Devices EU Medical Device Regulations 5
M Informational EU – Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR) – Information from the Irish and German delegations Medical Device and FDA Regulations and Standards News 0
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
M Medical Device News EU – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics Medical Device and FDA Regulations and Standards News 0
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
Similar threads


















































Top Bottom