CFG-type Document for Medical Devices mfg/exported from OUS?

R

Rannem

#1
I need to renew a product registration in China and one of the requirements is a Certificate to Foreign Government from FDA. However, some of the devices are manufactured OUS and will ship from the mfg. site. Form FDA 3613 now states the following on the Exporter's Certification Statement: Each product(s) identified for export is being exported from the United States. My question is how do I get a CFG-type document for the devices shipping from OUS? I really don't want to force everything to/through the US! This is a new requirement for me - my understanding was that a CFG was for product "legally marketed" in the US.

Any suggestions?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: CFG-type document for devices mfg/exported from OUS?

A CFG or equivalent certification indicates that the device in question is legally marketable in its country of manufacture, and is issued by that country of manufacture. If you have a device that is manufactured in Country X, you should provide Country X's certificate of legal marketability.

If China is not willing to accept that other country's CFG-equivalent as having the same value as a US FDA CFG, because they don't think that other country's medical device regulatory system is as rigorous as that of the US...well, more difficult international trade is a predictable downside of manufacturing outside of the rigorous-regulatory-system countries.
 

RA Guy

Involved In Discussions
#3
Rannem

You'd go the the respective Ministry of Health (or equivalent) in the country where each device is manufactured and request CFG or equivalent (CFS, etc.)

I did this with China a few years ago with certs from FDA, Health Canada and Italian MOH and did not encounter any issues from SFDA.

Good luck.
 
Thread starter Similar threads Forum Replies Date
A Can a US manufacturer put export only products on a CFG? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J US Manufacturer of Export Only Exempt Products applying for CFG 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V Recording CMM dimensional results on CFG-1003 APQP and PPAP 3
K CFG (certificate of foreign government) Requestor Other US Medical Device Regulations 0
F EU IVD registrations - CFG or CFS - Differences EU Medical Device Regulations 1
M Eligible to obtain certificate of foreign government (CFG) Other Medical Device Regulations World-Wide 15
S Certificate to Foreign Government (CFG) - who is an Exporter ? US Food and Drug Administration (FDA) 2
S CFG Certificate for Medical Device Registration in India Other Medical Device Regulations World-Wide 4
N Foreign Manufacturer requesting FDA's CFG over their country's FSC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
N CFG-1003 ..... on steroids - CFG-1003 (like) form that works, and well Excel .xls Spreadsheet Templates and Tools 3
S FDA Form 3613 [Certificate to Foreign Government (CFG)] - Manufacturer Information 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
D AIAG PPAP Manual Forms: CFG-1003, CFG-1004, CFG-1005 APQP and PPAP 3
Michael Malis FDA changed the criteria for Certificate to Foreign Government (CFG) on 12/08/09 US Food and Drug Administration (FDA) 1
M CFG - Certificate for Foreign Government - Medical Device Company based in CA, USA US Food and Drug Administration (FDA) 4
M Updating Certificate of Foreign Government (CFG's) Other US Medical Device Regulations 18
C Strange test result form - CFG-1003 form Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C List of Countries that require 'Certificates to Foreign Governments' (CFG) US Food and Drug Administration (FDA) 4
J CFG-1003 Form for Dimensional Results - Excel .xls or Word .doc Excel .xls Spreadsheet Templates and Tools 5
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Nihls MSA Study Type 1 (CMM) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
D Separation of F-type applied part and remaining parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A AMSQQP416E Class 2 type 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
N BF-type applied part MOPP vs secondary IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Marcel DS GOST-R (Type approval for Vehicles in Russia) Other ISO and International Standards and European Regulations 0
S Type 1 Gage R&R or something else? Reliability Analysis - Predictions, Testing and Standards 6
I Old Time Scatter diagrams for defect type and location- software Quality Tools, Improvement and Analysis 7
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
N Infant radiant warmer - Heater Quartz Element type Other Medical Device Related Standards 0
N % Tolerance - Type 1 study on the gages, then a gage R&R (ANOVA) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Definitive answer on Type 1 vs Type 2 vs Type 3 Gage Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
F Operator Manual and Type B Uncertainty Measurement Uncertainty (MU) 3
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
M SI #7 8.4.2.1 Type and extent of control_supplemental IATF 16949 - Automotive Quality Systems Standard 3
B F-type applied part - Separation from ALL(?) other parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
A Gage type 1 study on CMM Capability, Accuracy and Stability - Processes, Machines, etc. 2
A IATF Sanctioned Interpretation No. 7 - Type and Extent of Control (supplemental) IATF 16949 - Automotive Quality Systems Standard 4
K F-TYPE APPLIED PART IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
I AS9100 8.4.2 Type and Extent of Control - External provider test reports Manufacturing and Related Processes 24
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
R In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom