CFDA (China Food and Drugs Administration) Audit Finding Classifications

O

OG_QA

#1
Can someone explain or provide a link on how CFDA classifies their audit observations/findings (i.e FDA 483, NSAI CAT 1, CAT 3, CAT3). I believe they have two types "Critical" & "General" I would like more information.

Thank you for your time.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
Thread starter Similar threads Forum Replies Date
S SFDA (China's state Food and Drug Administration) changed to CFDA China Medical Device Regulations 6
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
J Change management with CFDA approved devices China Medical Device Regulations 1
shimonv Submissions to NMPA (formerly CFDA) Paid Consulting, Training and Services 0
Gamula CFDA Biological Evaluation Report China Medical Device Regulations 2
E RF Energy Treatment Devices for CFDA Registration China Medical Device Regulations 1
shimonv CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English) China Medical Device Regulations 8
R CFDA submission fees as of May 2015 China Medical Device Regulations 4
Y Is CFDA registration required if the full system is registered by our distributors? China Medical Device Regulations 2
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
P Is an English version of CFDA YY0664-2008 available? China Medical Device Regulations 3
J CFDA issues Guiding Opinions on Enhancing the Construction of Food and Drug Inspectio China Medical Device Regulations 1
A CFDA - List of Class II Medical Devices exempt from Clinical Trials China Medical Device Regulations 2
R CFDA updated five regulations to be effective from October 1, 2014 China Medical Device Regulations 16
C CFDA announced 120 new Medical Device Standards - July 2014 China Medical Device Regulations 0
C CFDA MD regulation_20140331 - Comes into effect June 01, 2014 China Medical Device Regulations 33
pittmatj CFDA Requests Biocompatibility Evaluation for Raw Materials ISO 13485:2016 - Medical Device Quality Management Systems 6
B Amending Registration with CFDA due to Change in Site of Manufacture China Medical Device Regulations 3
M How to communicate the change in company address to CFDA ? China Medical Device Regulations 1
T CFDA seeks for public comments on newly revised medical device classification rules China Medical Device Regulations 1
T CFDA Simplifies Medical Device Re-Registration Process China Medical Device Regulations 1
Q SFDA/CFDA Shortend Registration Appendixes China Medical Device Regulations 4
T The CFDA recently issued new Medical Device Industry Standards China Medical Device Regulations 0
T CFDA issued second list of Class II devices exempt from clinical studies (10/11/13) China Medical Device Regulations 4
T CFDA recently classified 23 products (9/27/13) China Medical Device Regulations 5
T CFDA issues notice for Small Oxygen Respirators (9/16/2013) China Medical Device Regulations 0
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
I Selling medical gown and mask in China China Medical Device Regulations 0
D Are Eye drops made in China classified as medical device in China? ISO 13485:2016 - Medical Device Quality Management Systems 0
F Medical devices_hong kong_post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
N China - Start manufacturing before change approval? China Medical Device Regulations 1
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 7
J China NMPA medical device submission timelines and clearance rates China Medical Device Regulations 2
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
T China ROHS exemptions - Are there any exemptions for ROHS 2 China? REACH and RoHS Conversations 0
E Original Brand Labeler (OBL) in China China Medical Device Regulations 2
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
S China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices China Medical Device Regulations 1
F China Clinical Trials Requirements Other Medical Device Regulations World-Wide 2
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
Z I need help with getting a CFS in China Manufacturing and Related Processes 2
F China Device Assisted Technology Clinical Trial China Medical Device Regulations 4
Similar threads


















































Top Bottom