How to find a good online CFDA submission training?

lyannastark

Starting to get Involved
#1
I want to learn more about CFDA submission training. Now, most of my clients have a plan to get a CFDA approval in near future (1-2 years).

Are there any good online trainings that you can recommend? Or other useful documents/resources?

Thanks!
 
Elsmar Forum Sponsor
#2
You may want your clients to refer to the China Medical Device Agency as NMPA. CFDA is no longer the regulatory authority (since 2018).

RAPS is a good organization to utilize and/or become a member for useful documents/resources.
 
#3
There are online courses in CMDE(Center for Medical Device Evaluation) website.
here is a link about Introduction of Medical Device Registration Process
cmde.png
 
#4
I have found this website

On its regulation compliance service page, they also offer customized trainings, maybe you can ask them for an enquiry. I usually browser some pharmaceutical regulation news on this website, quite uesful and up-to-date. Hope it helps you.
1640852054510.png
 
#5
This is too coincidental. I am in China and I am looking for FDA PMA registration. Could we share the registration experience between the two countries?
 
#6
I want to learn more about CFDA submission training. Now, most of my clients have a plan to get a CFDA approval in near future (1-2 years).

Are there any good online trainings that you can recommend? Or other useful documents/resources?

Thanks!
You can either visit CMDE official website -- training tab or you can leave your message to me. i am willing to assist you.
 
Thread starter Similar threads Forum Replies Date
K Help me find an online degree in English from an accredited college. Training - Internal, External, Online and Distance Learning 2
J0anne How to find Certifying Bodies for US based & sold Medical Devices? US Medical Device Regulations 11
I Where to find MDR compliance device? EU Medical Device Regulations 6
John Predmore Informational Can you find the error in the spreadsheet? Misc. Quality Assurance and Business Systems Related Topics 3
Ajit Basrur Where to find a pagination requirement as "Page x of y"? ISO 13485:2016 - Medical Device Quality Management Systems 7
G How to find applicable standards for a new product? EU Medical Device Regulations 6
A How to find Info about updated Standards EU Medical Device Regulations 2
D Searching for attachments can't find it Forum News and General Information 3
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
S Looking to find a pharmaceutical manufacturer that would be interested in buying or licensing a USDA 510k clearance General Information Resources 4
L How to find a good 510(k) submission training? Other US Medical Device Regulations 2
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
T ANOVA analysis to find F test. Using Minitab Software 3
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 6
I How to find required testing for a specific device? Other US Medical Device Regulations 3
N How to find column number for the last non-empty column? Using Minitab Software 0
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 2
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Where can I find examples of PPAP? APQP and PPAP 6
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
C TL-9000 Certifying Body Issue - Auditor failed to find an issue for 10 years TL 9000 Telecommunications Standard and QuEST 16
R How to find out the UMDNS code for medical devices CE Marking (Conformité Européene) / CB Scheme 1
M Plating standards - Where to find information AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
R Specification on flare testing extruded aluminum - Where to find Design and Development of Products and Processes 1
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
I Moving into Clinical Trials and need to find GMP Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Where to Find DEV and DFE numbers on FDA Website Other Medical Device and Orthopedic Related Topics 3
P Calibration in the UK to ISO 17025..cant find anyone ISO 17025 related Discussions 8
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
G Where I could find any project HSE plan templates Occupational Health & Safety Management Standards 4
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
M How to find the number of required data - Correlation with 4 variables Using Minitab Software 2
I Where to find VDA 6.3 Robust Production Process (rpp) PDF file ? VDA Standards - Germany's Automotive Standards 1
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
I Non-functional Corrective Action - Could Not Find some Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
J Where can I find a product's CE Mark Number? CE Marking (Conformité Européene) / CB Scheme 20
L Find Local Authorized Representative (LAR) for medical device EU Medical Device Regulations 5
H How to find a good ISO 9001 Implementation Consultant in Calgary, Canada? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 8
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom