CFDA Simplifies Medical Device Re-Registration Process

T

treesei

#1
The CFDA announced today that it simplified the re-registration process of medical devices. Manufacturers are no longer required to submit product standard, testing reports for registration purposes, and IFU if there is no change in the product, its standard, and its IFU, or if the only change is the address of production. If the change(s) is with the product's intended use, model, specification, standard, performance, structure, or composition,the manufacturer is required to submit technical information relevant to the changes but no longer need to submit complete product standard, testing reports for registration purposes, nor IFU.
http://www.sda.gov.cn/WS01/CL0087/94917.html
 
Last edited by a moderator:
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
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
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
Gamula CFDA Biological Evaluation Report China Medical Device Regulations 2
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
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
O CFDA (China Food and Drugs Administration) Audit Finding Classifications China Medical Device Regulations 1
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
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
S SFDA (China's state Food and Drug Administration) changed to CFDA China Medical Device Regulations 6
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 3
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom