SBS - The best value in QMS software

Testing in China accepted by the USFDA

J

Jennifer27

#1
Dear Experts,

We are working on a Blood Glucose Monitoring device. We are looking to perform electrical safety and EMC testing per IEC standards to support a submission to the FDA. We requested quotes from lots of labs. One quote was from TUV SUD China. We are interested in doing our testing in China because our contract manufacturer is in China.

I am wondering if we get testing done in China, will it be acceptable by the FDA as long as its executed by an accredited lab and per internationally recognised standards like the IEC 60601?

Please advise.

:thanx:

Jen
 
Elsmar Forum Sponsor
M

MIREGMGR

#4
We have biocompatibility testing done quite often by an appropriately certified and credentialed lab in China. We've submitted reports from that lab in relation to 510(k) processes without the test lab being a problem.

It of course is always necessary to follow FDA's requirements and expectations as to procedure...not just the minimum per the standard, but whatever FDA expects per their guidances.
 
Thread starter Similar threads Forum Replies Date
K ISO 9001:2015 AVL - New Chinese standards requiring all testing of materials be done in China ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
R Is Biocompatibility Testing required for Implantable Class III Devices sent to China China Medical Device Regulations 3
K High Risk Medical Device Type Testing (China Requirements) China Medical Device Regulations 5
A Biocompatibility testing & Registration in China ISO 13485:2016 - Medical Device Quality Management Systems 5
H Biocompatibilty Testing - National Test Centre (NTC), China ISO 13485:2016 - Medical Device Quality Management Systems 3
O FDA holding toothpaste imported from China at Customs for testing? US Food and Drug Administration (FDA) 12
E SI 9000 Part 4 - Testing requirement that is imposed in China Other ISO and International Standards and European Regulations 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
P Testing cloud-based backups IT (Information Technology) Service Management 7
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Flammability testing Reliability Analysis - Predictions, Testing and Standards 0
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
K When is Bioburden Testing Required? Other Medical Device Related Standards 4
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 3
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
JoCam Mobile Patient Hoists and Electrical Testing Other Medical Device Related Standards 0
T Interlaboratory comparison or proficiency testing in destructive testing of welded joints ISO 17025 related Discussions 3
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam MDL in Canada without Canadian Electrical Testing Canada Medical Device Regulations 0
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom