SFDA Registration Fees for a Class II Product in China

M

Mondo 22

#1
All,

Can anyone help, i am trying to locate the SFDA registration fees for a Class II product in China.

Any help would be appreciated.

Thanks,
Ray
 
Elsmar Forum Sponsor

sreenu927

Quite Involved in Discussions
#2
Hi,

For type testing, depending on the instrument it varies from 3000 ~ 75000 (RMB).
USer documentation Translation costs around US$ 5000.00

If it is reagent, then it will be even high for type testing!

Regards,
Sreenu
 
Thread starter Similar threads Forum Replies Date
Q SFDA/CFDA Shortend Registration Appendixes China Medical Device Regulations 4
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
R Is an Audit Report needed for SFDA Medical Devices Registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
M New Regulation for Medical Devices Registration in China SFDA Test Labs China Medical Device Regulations 31
K One time export to Saudi Arabia: SFDA and MDMA Other Medical Device Regulations World-Wide 2
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 Medical Device Manufacturing Enterprise License from SFDA China Medical Device Regulations 2
J Is the SFDA in China in the process of updating their Medical Device Regulations ISO 13485:2016 - Medical Device Quality Management Systems 3
J SFDA Finalizes its Rules on Packaging and Labeling of Imported Medical Devices China Medical Device Regulations 0
M SFDA Legal Agent and After Sales Agent in China - Differences? China Medical Device Regulations 3
J SFDA Labeling Requirements prior to import to any Chinese territory China Medical Device Regulations 2
G China SFDA Medical Device Software Requirements China Medical Device Regulations 15
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
P Software Changes - Is an FDA guidance type of document available from SFDA (China)? China Medical Device Regulations 2
M Managing Changes to an SFDA Registered Device China Medical Device Regulations 6
M SFDA (China) Device Classification China Medical Device Regulations 8
M Impact of changing ISO 13485 registrar / notified body on Chinese SFDA approval ISO 13485:2016 - Medical Device Quality Management Systems 3
J SFDA Biocompatibility Test Report Requests (China) ISO 13485:2016 - Medical Device Quality Management Systems 10
S SFDA Regulation of Medical Device Recall (Interim) - MOH decree No. 82 China Medical Device Regulations 1
O Mystery of China SFDA (State Food and Drug Administration) and CCC ISO 13485:2016 - Medical Device Quality Management Systems 26
C SFDA Approval (China) - Changing Locations China Medical Device Regulations 12
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
H Medical device Product Registration Registrars and Notified Bodies 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
Q Is Establishment Registration Necessary? Other US Medical Device Regulations 1
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
JoCam Registration of other manufacturers devices UK Medical Device Regulations 3
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M Establishment Registration US Food and Drug Administration (FDA) 3
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
J Brazil Registration Holder Other Medical Device Regulations World-Wide 0
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A 510(k) registration and listing US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom