Registering a Software medical device (SaMD) in China

kreid

Involved In Discussions
#1
Hello,
Does anyone know where I can find information (in English) on how one would register a software medical device in China?
Thanks
 
Elsmar Forum Sponsor
#3
Hi,
According to me, it will better to contact with the best Medical device manufacturing company like Peterstechnology.com. They will definitely make you confirm regarding the registration method.
Thank you
 
Thread starter Similar threads Forum Replies Date
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
shimonv The regulatory process for registering a Medical Device in India Other Medical Device Regulations World-Wide 2
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J ISO13485 Certification Scope - Registering a Subset of our Products ISO 13485:2016 - Medical Device Quality Management Systems 9
M Registering a Class II Medical Device with no Predicate Device - FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M FDA Submission Consultancy - Registering and marketing our products in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil Other Medical Device Regulations World-Wide 2
A Registering Medical Products in Canada - DIN EN 14971 vs. CAN/CSA-ISO 14971 Canada Medical Device Regulations 5
R Registering Medical Device in Brazil ANVISA - Fee Structure Other Medical Device Regulations World-Wide 1
K Job Shop - Registering to AS9100 vs. ISO 9001 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 27
N Regulations for Registering Medical Devices in South Korea Other Medical Device Regulations World-Wide 6
K Registering to AS9100 - Already ISO/TS-16949 Registered AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
T Difference between registering as a Lead Auditor with RABQSA vs. IRCA ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
M Medical Devices Registering (Registration) Procedure in South Africa Other Medical Device Regulations World-Wide 4
T Product Listing (registering medical devices) in Indonesian Market ISO 13485:2016 - Medical Device Quality Management Systems 2
R Requirements for Registering and Listing with the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
F Contract Manufacturer Registering with the FDA - Medical Devices - 21 CFR 807.20 ISO 13485:2016 - Medical Device Quality Management Systems 11
A Registering multiple sites to ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Old Time Scatter diagrams for defect type and location- software Quality Tools, Improvement and Analysis 3
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C Is my software an accessory? Telecommunication between HCP and patients EU Medical Device Regulations 10
K Verify Software Architecture - supporting interfaces between items IEC 62304 - Medical Device Software Life Cycle Processes 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
R MSA for ATE (Automatic Test Equipment Embedded Software) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
B ISO 14971 Applied to Software ISO 14971 - Medical Device Risk Management 2
N ERP Software Implementation Manufacturing and Related Processes 3
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
J Designing new gauge tracking software IATF 16949 - Automotive Quality Systems Standard 4
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
C MDR - Question around software accesories EU Medical Device Regulations 2
S Software for Supplier Charge back and internal PPM General Information Resources 2
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
S Recommendation for user friendly Gaga R&R and Cpk software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
M HR (Human Resources) based software recommendations Human Factors and Ergonomics in Engineering 2
V Gage Management and Gage R&R Software General Measurement Device and Calibration Topics 1
Similar threads


















































Top Bottom