Is the SFDA in China in the process of updating their Medical Device Regulations

J

jampot

#1
I have been told that the SFDA in China are in the process of updating their medical device regulations. Is anyone on the forum aware of this update, when it will be published and where the text can be accessed?

Many thanks
Jampot
 
Elsmar Forum Sponsor
J

Jason.Wu

#3
Hi Jampot
You are exactly right, it may will be publish soon.
You could find the reguation on SFDA website after published, but only Chinese version access, I think.

Jason wu
 
Thread starter Similar threads Forum Replies Date
S SFDA (China's state Food and Drug Administration) changed to CFDA China Medical Device Regulations 6
J China's SFDA - Innovated Medical Device Special Approval Procedures China Medical Device Regulations 1
M China SFDA requirements for Endoscopes Various Other Specifications, Standards, and related Requirements 2
M SFDA Legal Agent and After Sales Agent in China - Differences? China Medical Device Regulations 3
M SFDA Registration Fees for a Class II Product in China China Medical Device Regulations 2
G China SFDA Medical Device Software Requirements China Medical Device Regulations 15
P Software Changes - Is an FDA guidance type of document available from SFDA (China)? China Medical Device Regulations 2
M SFDA (China) Device Classification China Medical Device Regulations 8
J SFDA Biocompatibility Test Report Requests (China) ISO 13485:2016 - Medical Device Quality Management Systems 10
O Mystery of China SFDA (State Food and Drug Administration) and CCC ISO 13485:2016 - Medical Device Quality Management Systems 26
M New Regulation for Medical Devices Registration in China SFDA Test Labs China Medical Device Regulations 31
C SFDA Approval (China) - Changing Locations China Medical Device Regulations 12
Q SFDA/CFDA Shortend Registration Appendixes China Medical Device Regulations 4
K One time export to Saudi Arabia: SFDA and MDMA Other Medical Device Regulations World-Wide 2
M Medical Device Manufacturing Enterprise License from SFDA China Medical Device Regulations 2
J SFDA Finalizes its Rules on Packaging and Labeling of Imported Medical Devices China Medical Device Regulations 0
J SFDA Labeling Requirements prior to import to any Chinese territory China Medical Device Regulations 2
S SFDA - Product Registration and Establishment Registration China Medical Device Regulations 5
I SFDA (Saudi Food and Drug Authority) and MDMA Registration System Other Medical Device Regulations World-Wide 5
J SFDA Product Quality Tracking Report - Anyone with experience to share? China Medical Device Regulations 2
M Product classification of SFDA for borderline products China Medical Device Regulations 4
R Is an Audit Report needed for SFDA Medical Devices Registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
M Managing Changes to an SFDA Registered Device China Medical Device Regulations 6
M Impact of changing ISO 13485 registrar / notified body on Chinese SFDA approval ISO 13485:2016 - Medical Device Quality Management Systems 3
S SFDA Regulation of Medical Device Recall (Interim) - MOH decree No. 82 China Medical Device Regulations 1
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
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
Similar threads


















































Top Bottom