How to communicate the change in company address to CFDA ?

max.polix

Involved In Discussions
#1
My company has just changed the legal address, actually from a notary's office to the address of our headquarters. Don't ask me way the legal address was at that office in the past :confused:.

Question: should I notify this change to CFDA? Consider that the Chinese label on our products reports also the legal address. If I have to notify, would it be a renewal of the registration (all the documents submitted, passed to the CFDA screening for months, ....) or just a communication letter?

Let me add that our top management is also thinking of the relocation of some products manufacturing to a different plant. Would it call for a full re-registration of the products?

Thanks.
Max
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
My company has just changed the legal address, actually from a notary's office to the address of our headquarters. Don't ask me way the legal address was at that office in the past :confused:.

Question: should I notify this change to CFDA? Consider that the Chinese label on our products reports also the legal address. If I have to notify, would it be a renewal of the registration (all the documents submitted, passed to the CFDA screening for months, ....) or just a communication letter?

Let me add that our top management is also thinking of the relocation of some products manufacturing to a different plant. Would it call for a full re-registration of the products?

Thanks.
Max
Yes.

I also assume that both adddresses are in China, right ? To get more clarity on the notification, I would suggest to visit the CFDA office for more details.
 
Thread starter Similar threads Forum Replies Date
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4
C SVHC Lead - Communicate in the supply chain under Article 33 of the REACH Regulation REACH and RoHS Conversations 1
J AS9100D Cl. 8.4.3d - The organization shall communicate to external providers... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Is a CAR addressed to your customer the best way to communicate with? Misc. Quality Assurance and Business Systems Related Topics 7
N What is the Best Way to Promote/Communicate our Goals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B How do I communicate my frustations with my boss ? Career and Occupation Discussions 7
K How to Communicate to Operators (Especially Foreign Workers) - Language Issues Misc. Quality Assurance and Business Systems Related Topics 11
H How do you communicate the quality checks to the production supervisors? Records and Data - Quality, Legal and Other Evidence 4
R Implementing ISO 14001 - How do you Communicate to All the other Staff? ISO 14001:2015 Specific Discussions 2
S How to Communicate with Production People to Prevent Quality Arguments Quality Manager and Management Related Issues 21
V Management Representative - Communicate with customers and other interested parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
O Communicate externally about significant environmental aspects - Clause 4.4.3 Miscellaneous Environmental Standards and EMS Related Discussions 6
K Creative Ways to Communicate Customer Complaints to Manufacturing. Customer Complaints 10
Peter Fraser Business Process Modeling Notation (BPMN) to Communicate Business Processes Document Control Systems, Procedures, Forms and Templates 13
E How can I get my customer to communicate their requirements? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
M Looking for Best Way to Communicate Process Changes to Production Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Clause 5.5.1 - Communicate responsibilities and authorities within the organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna A useful Guide to communicate the value of your EMS to external stakeholders Miscellaneous Environmental Standards and EMS Related Discussions 1
N How does your Company Communicate Requirements to Employees Other ISO and International Standards and European Regulations 24
S When to change the status of a GTIN from "Premarket" to "In Use" ? US Medical Device Regulations 2
Y Is there any EU Significant change guidance issued? EU Medical Device Regulations 5
B How to change hour format to text but not changing the number ? Excel .xls Spreadsheet Templates and Tools 1
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 3
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
C Change Management Process ISO 14971 - Medical Device Risk Management 8
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
N Change Control for processes & products Manufacturing and Related Processes 7
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7
D Laboratories listed in the Declaration of Conformity change Canada Medical Device Regulations 1
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 17
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
N Cleanroom Classification Change Other Medical Device Related Standards 7
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Change Request Documents - What's Typical These Days? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
NDesouza Management of Change (MOC) Manufacturing and Related Processes 11
H Customer Specific Change in a SaaS SAMD IEC 62304 - Medical Device Software Life Cycle Processes 1
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
lanley liao Questions regarding the change of critical suppliers and key personnel Oil and Gas Industry Standards and Regulations 5
I What revalidation is necessary if we change parts in a WFI loop ? Qualification and Validation (including 21 CFR Part 11) 1
Y Exporting data to the cloud is a "Significant Change"? EU Medical Device Regulations 5
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
S Change management with FAA Federal Aviation Administration (FAA) Standards and Requirements 0
R Revalidation under VDmax25 following material change ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom