China UDI Implementation for October 1st 2019

How to manage your QMS while working remotely.
Elsmar Forum Sponsor
M

M.R.Falco

Starting to get Involved
#4
#4
Wow, thanks for the heads up on this! Definitely something I'm going to want to look into further and apparently with some urgency. :LOL:
 
JoshuaFroud

JoshuaFroud

Involved In Discussions
#5
#5
Thanks Ajit. Interesting read and a rather short timeline for implementation!

Certainly important to anyone who is currently doing business in China.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
O Radio Modular approval in China 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
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
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
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
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
Edward Reesor Exporting from China - Unified Social Credit Code ISO 13485:2016 - Medical Device Quality Management Systems 2
C Are we required to obtain a Certificate of Free Sales for export to China? Other Medical Device Regulations World-Wide 6
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
P China drug packaging DMF China Medical Device Regulations 0
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
B China GB4943.1 Safety Requirements - PCB Markings China Medical Device Regulations 0
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
F Information on China's Medical City Other Medical Device Regulations World-Wide 4
B Is ISO 15254:2009 a requirement for China for ophthalmic products market? China Medical Device Regulations 1
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
H Research Use Only (RUO) Medical Devices in China China Medical Device Regulations 7
B Strategy for Registration a Medical Device in China China Medical Device Regulations 2
JoCam Labeling Requirements for Medical Devices Made in China EU Medical Device Regulations 6
B FDA Listing of a Class I Medical Device in USA (Manufactured in China) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
Q Correlation between ASTM & China's GB (Guobiao) / YY Standards China Medical Device Regulations 4
O CFDA (China Food and Drugs Administration) Audit Finding Classifications China Medical Device Regulations 1
F China Medical Device Labeling - Not approved for use, is for an exhibition EU Medical Device Regulations 4
I Shipping Product from Canada to China - Where to obtain the Certificate of Origin? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
J Testing in China accepted by the USFDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Good Supply Practices that will be effective on March 1 2015 in China China Medical Device Regulations 2
bgoers PFMEA, Internal Auditing, Corrective Action Training In Native Language (China) Training - Internal, External, Online and Distance Learning 1
T Free Sale Certificate - China, Vietnam, Philippines and Thailand Other Medical Device Regulations World-Wide 8
W QMS and/or ERP software choices for both US and China Quality Assurance and Compliance Software Tools and Solutions 2
M China Medical Device Requirrements - User Manual Information China Medical Device Regulations 2
JanWarner Importing a Finished Medical Device from China (tooth whitener w/ peroxide) China Medical Device Regulations 2
Similar threads
Top Bottom