Interpreting China Medical Device regulations/standards

Q

QSEngineer20850

Registered
#1
#1
I am working on a project to do gap assessments for my company on some Chinese regulations/standards and I am having difficulty interpreting them. There are a few mentions of the employer keeping medical records and/or immunization records for employees who work on the manufacturing line but that would be a big HIPAA issue, not to mention privacy.

There are many more that I am also having trouble with and I was wondering if anyone had a good resource or tool that could help link the regulations to CFR820 or ISO13485. Any input would be appreciated.
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
I can tell you from working experience with NMPA that there is a good measure of similarity between CFR 820, ISO 13485 and NMPA regulation but there is no real good recourse or tool for doing a gap analysis at a lower level.
You will need to hook up with a local RA/QA agency to help you with that.


Shimon
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q Interpreting Tensile Charts General Measurement Device and Calibration Topics 0
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
K PACS - interpreting MDD and Borderline Guidance CE Marking (Conformité Européene) / CB Scheme 5
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
D Interpreting Normal vs Weibull Capabilities Capability, Accuracy and Stability - Processes, Machines, etc. 4
P Interpreting Span Measurement - P95-P5 Six Sigma 1
B Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012 ISO 14971 - Medical Device Risk Management 1
B Interpreting "misuse" when assessing Hazardous Situations ISO 14971 - Medical Device Risk Management 2
S Interpreting clause 4.1.5 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Help interpreting 21 CFR Part 806 (corrections and removals) Other US Medical Device Regulations 1
G Interpreting Type 1 MSA (Measurement Systems Analysis) Results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Help interpreting MIL-STD-105E Single Sampling Plans Tables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
I Interpreting Product Realization (Clause 7) in ISO 9001:2008 for Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V GD&T Interpreting Datums in Two Single Segmented Position Tolerances Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Interpreting X bar and R Control Charts Statistical Analysis Tools, Techniques and SPC 2
B Help with interpreting stock market terminologies Coffee Break and Water Cooler Discussions 4
V Interpreting Zinc Plating Specification GMW 3044 - 6K96/48 APQP and PPAP 2
K Interpreting and Applying 7.3.2 Design and Development Inputs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Interpreting the Calibration Report for my Dial Indicator General Measurement Device and Calibration Topics 3
J Interpreting Process Capability results and ratios Capability, Accuracy and Stability - Processes, Machines, etc. 1
B Length Measure - Interpreting Calibration Results and Measurement Uncertainty (MU) Measurement Uncertainty (MU) 3
S Interpreting Level of Confidence - Round Robin for Tensile Testing - Help needed Statistical Analysis Tools, Techniques and SPC 4
M Interpreting AS9100 Clause 8.2.2 Internal Audit Requirements Internal Auditing 28
T Interpreting my t test in Minitab Using Minitab Software 2
S Interpreting Linear Regression Results from Minitab Using Minitab Software 15
optomist1 Interpreting LMC for Pattern of Slots (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
optomist1 Interpreting Minitab Test For Equal Variances Using Minitab Software 3
V Interpreting Minitab Gauge R&R Results Using Minitab Software 6
A ISO 2081 - Interpreting Coating Thickness Other ISO and International Standards and European Regulations 3
L Interpreting Injection Molding Tooling Documents - Cavities Manufacturing and Related Processes 3
C Interpreting Gage R&R Results - 3 operators, 3 iterations and 10 parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
M Interpreting Measurement Uncertainty for Temperature PRT probes Measurement Uncertainty (MU) 2
N Interpreting Hygrometer Calibration Uncertainty - Temperature Coefficient Measurement Uncertainty (MU) 1
mr500 Interpreting Decimals in the mm state - Off Wall Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
J Interpreting clause 7.5.2.1 (validation of software used in production & service) ISO 13485:2016 - Medical Device Quality Management Systems 2
E Interpreting Partial Least Square Results Using Minitab Software 1
C Interpreting Outside Laboratory Calibration Certificate Measurement Uncertainty (MU) 3
M Interpreting MIL-PRF-19500 (Performance Spec, Semicon Dev) - What is LTPD of 20 - ??? Manufacturing and Related Processes 4
T Rules for interpreting control charts Statistical Analysis Tools, Techniques and SPC 2
Q Interpreting Responsibility and Authority Clause 5.5.1 ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 18
H Interpreting 'Evaluation of compliance' in ISO 14001 Internal Auditing 4
P Micrometer Gage R&R study - Interpreting the data and suggestions Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
W Interpreting a Normal Probability Plot Statistical Analysis Tools, Techniques and SPC 4
Wes Bucey "Downsizing" ramifications - Evaluating and Interpreting the News World News 0
Q Interpreting calibration result of Air Particle Counter on Counting efficiency General Measurement Device and Calibration Topics 1
A Particle Counter Results - Interpreting Data for a Class 100,000 Cleanroom Other Medical Device Related Standards 12
M GD&T Q&A session - Interpreting FCF (Feature Control Frame) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 43
N TL 9000 - Help Interpreting Normalization Unit for Measurements TL 9000 Telecommunications Standard and QuEST 2

Similar threads

Top Bottom