Managing Changes to an SFDA Registered Device

max.polix

Involved In Discussions
#1
For me, this is one of the many unclear points in Chinese regulation for Medical Devices: how to manage a change to an existing device registered at the SFDA.

I am interested in sharing experience with people that already have dealt with this issue.

For performance changes or introduction of new features we have always submitted a new registration.
But what can be considered a "minor change" to the device, so that a new registration is not needed?

I see that during the first registration phases the SFDA is very keen on getting photos of every part of the equipment, so I wonder whether a change in colour of the plastic cover or a in the shape to keep it in fashion needs a formal communication to the SFDA.

Does anybody have ideas or suggestions for source of information?

Thanks.
m.p.
 
Elsmar Forum Sponsor
J

Jamiechina

#3
Generally speaking, if you just change colour of the device. You don't need to submit a new registration. You can just provide an evidence to prove the material has not change(it related to fire protection). That's OK.

If you change the shape of the device. You also don't need to submit a new registration. But you must provide a test report to prove the perfomance and safty have not changed.
 

max.polix

Involved In Discussions
#4
Thank you, Jamie.

When you say "provide evidence" do you mean that one is supposed to submit some documentation to the SFDA or just keep it in case they ask questions or make problems during an inspection?

Thanks.
Massimo
 

sreenu927

Quite Involved in Discussions
#5
Hi Jamie,

If the manufacturing location is changed for a high risk device that is registered with SFDA, what to do?
-re-registration?
- just notify and submit ISO 13485 cert?

Thanks,
Sreenu
 
J

Jamiechina

#6
Thank you, Jamie.

When you say "provide evidence" do you mean that one is supposed to submit some documentation to the SFDA or just keep it in case they ask questions or make problems during an inspection?

Thanks.
Massimo
Either is OK. As I know, the manufactures always choose the second one.
 
J

Jamiechina

#7
Hi Jamie,

If the manufacturing location is changed for a high risk device that is registered with SFDA, what to do?
-re-registration?
- just notify and submit ISO 13485 cert?

Thanks,
Sreenu
If you change the manufacturing location, you must re-registration.
 
Thread starter Similar threads Forum Replies Date
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
J Design Verification - Managing Changes Design and Development of Products and Processes 4
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
S Q1 Manufacturing Site Assessment - Managing Post-Job 1 Changes Procedure Manufacturing and Related Processes 1
Q Filtering ECR/ECO by quality management? Managing Engineering Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
M Medical Device News DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients Medical Device and FDA Regulations and Standards News 0
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Microbiology Testing - Managing a Microbiology Process Hospitals, Clinics & other Health Care Providers 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
I Any recommendations on software for managing the APQP, PPAP, PFMEA, Control Plan etc? Quality Assurance and Compliance Software Tools and Solutions 2
R Managing Tooling Condition at Suppliers Supplier Quality Assurance and other Supplier Issues 6
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Looking for Practical Advice in Managing Measurement Uncertainties Measurement Uncertainty (MU) 3
L Managing ITP with an ERP system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Managing a Significant Number of Outstanding Non-Conformities Nonconformance and Corrective Action 6
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing Inspection Records with a Database and Destroying Paper Records Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Process for Managing Documents which are Overdue for Review Document Control Systems, Procedures, Forms and Templates 17
B Are there any Standards related to Managing an Airport Various Other Specifications, Standards, and related Requirements 3
Q Managing Internal and Client Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Industry Best Practices for managing outside Engineering Consultants Design and Development of Products and Processes 3
Q Process or Departments - Document Content and Managing the Process Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Managing the Unexpected - Book Recommendation Book, Video, Blog and Web Site Reviews and Recommendations 1
T Internal Conflict of Interest in Managing Suppliers Supplier Quality Assurance and other Supplier Issues 2
L Managing Certificates of Analysis or Conformance for Products Quality Assurance and Compliance Software Tools and Solutions 4
T Managing Audit Reports and Schedules General Auditing Discussions 3
F Who manages QI projects? Quality or PMO? Managing Six Sigma and Lean Projects Six Sigma 2
Hami812 Attribute Data Gage R&R - Managing Data Sets - Minitab Using Minitab Software 2
E Nonconformity on managing documents for Electric Arc Furnace Manufacturing and Related Processes 4
D Managing an Employee Suggestion Program Quality Manager and Management Related Issues 4
K Managing Prerequisite Programme Activities Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Non Normal Data Managing - Clements Method to get Process Characteristics Statistical Analysis Tools, Techniques and SPC 8
J Managing New and Revised Electronic Documents (Procedures) - Share Point Document Control Systems, Procedures, Forms and Templates 8
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Managing Quality Risks in Construction Quality Manager and Management Related Issues 14
D Managing Product Risk Management ISO 14971 - Medical Device Risk Management 1
S EOQ (Economic Order Quantity) - Use for managing Customer Orders - asking help Lean in Manufacturing and Service Industries 5

Similar threads

Top Bottom