SBS - The best value in QMS software

Neutral Code Requirement - Medical Devices Outsourced from India

N

Nash27

Involved In Discussions
#1
#1
Hi All,

I hope someone could able to help me.

We are in process of outsourcing IV sets from our approved supplier from India. It has been informed by the supplier that to export the IV set they need to place the Neutral code which is their Indian FDA license number to be stated on each label/IFU (packaging), which is in the format of ABC/Drugs/X-123.

From my vague memory, it is true that Indian manufacturers are required to place the Neutral code, else the product would not be exported from India considering IV set falls in Drugs and cosmetics act.

I would like to confirm if this it is true or is there any way out, that could work between us and the supplier. We asked the supplier to provide neutral code on the outer cartons however they are persistent about the requirement to place the neutral code on individual packaging.

Thanks,
 
Last edited:
Elsmar Forum Sponsor
somashekar

somashekar

Staff member
Super Moderator
#3
#3
Nash27 said:
Hi All,

I hope someone could able to help me.

We are in process of outsourcing IV sets from our approved supplier from India. It has been informed by the supplier that to export the IV set they need to place the Neutral code which is their Indian FDA license number to be stated on each label/IFU (packaging), which is in the format of ABC/Drugs/X-123.

From my vague memory, it is true that Indian manufacturers are required to place the Neutral code, else the product would not be exported from India considering IV set falls in Drugs and cosmetics act.

I would like to confirm if this it is true or is there any way out, that could work between us and the supplier. We asked the supplier to provide neutral code on the outer cartons however they are persistent about the requirement to place the neutral code on individual packaging.

Thanks,
Click to expand...
Hi ...
It is label on the packages or containers...
There is no requirement that individual packages must have the neutral code.
See attached provision to rule 94 taken from CDSCO site.
 

Attachments

N

Nash27

Involved In Discussions
#4
#4
Thanks Somshekhar for your reply, very helpful, indeed.

Its label on the packaging medical devices (IV sets). Based on the supplier information the IV sets are classified under drugs act (will confirm the section) and hence their requirement to place the code.

I will confirm and post it again.
 
Q

QA-Man

#5
#5
somashekar said:
Hi ...
It is label on the packages or containers...
There is no requirement that individual packages must have the neutral code.
See attached provision to rule 94 taken from CDSCO site.
Click to expand...
Very helpful. I've been trying to get to the bottom of this for a few weeks.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
X Neutral Electrode IEC 60601-2-1 Test House IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Measurement Uncertainty for Neutral Salt Spray test to BS EN ISO 9227:2006 General Measurement Device and Calibration Topics 4
T Test Plates for MIL-DTL-1766: Chemically Neutral Wrapping Paper Reliability Analysis - Predictions, Testing and Standards 2
ScottK Music in the Office - good, bad, neutral? Career and Occupation Discussions 52
A Internal Audits - Are you Neutral and Unbiased? Do you react to the objective data? Internal Auditing 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
John Broomfield CIOB - Code of Quality Management Misc. Quality Assurance and Business Systems Related Topics 1
Z Labeler Code - Private labelling for OTC (Over the Counter) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
K REF symbol with product code in the IFU EU Medical Device Regulations 1
DitchDigger Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133) Occupational Health & Safety Management Standards 2
John Broomfield Informational Chartered Institute of Building - Code on Quality Management Service Industry Specific Topics 2
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S GMDN Code for Chitosan Products CE Marking (Conformité Européene) / CB Scheme 1
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
M How to Select FDA Medical Device Product Code? Other US Medical Device Regulations 10
L GMDN code wanted - Software for handling records Service Industry Specific Topics 9
R How to find out the UMDNS code for medical devices CE Marking (Conformité Européene) / CB Scheme 1
Marc Informational Apple Tells App Developers To Disclose Or Remove Screen Recording Code World News 0
S Is Software code documentation required for FDA premarket submissions? IEC 62304 - Medical Device Software Life Cycle Processes 2
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
S IAF Codes - Examples of what falls under each code General Information Resources 2
L GMDN code differences, Manufacturer and Sponsor Other Medical Device Regulations World-Wide 3
Edward Reesor Exporting from China - Unified Social Credit Code ISO 13485:2016 - Medical Device Quality Management Systems 2
H FDA product code and regulation number Other US Medical Device Regulations 3
R Statutory/Regulatory for NACE Code 25.9 (Manufacture of fabricated metal products) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc 2017 ICD-10-CM Diagnosis Code W56.22XA - Struck by orca Coffee Break and Water Cooler Discussions 0
Marc IAQG-OASIS - 9101:2016 Form 4: Cause Code Listing Now Included in Form AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W CPU BIST IEC 62304 - Embedded code has CPU instruction tests IEC 62304 - Medical Device Software Life Cycle Processes 2
S What is the IAF code for Medical Devices? Other Medical Device Related Standards 2
K Colour Code Requirements for Waste Bins/Bags Other ISO and International Standards and European Regulations 2
Marc Modified Google Glass can teach you Morse Code in four hours World News 0
A Is the Labour Code one of the legal requirements of ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Jen Kirley How to evaluate hazards in using bar code scanners in chemical manufacturing Occupational Health & Safety Management Standards 1
M Canada preferred Name Code (PNC) Canada Medical Device Regulations 3
S ISO 9001 and a safety management system based to ISM code ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
somashekar Do NB's want the Declaration of Conformity with GMDN code? EU Medical Device Regulations 14
Wes Bucey Code of Federal Regulations Electronic Copy Searchable Database Quality Manager and Management Related Issues 1
T What is the correct UMDNS Code for Tracheostomy Tube? Other Medical Device Regulations World-Wide 2
S Disposable Loop Electrode - GMDN/or UMDNS code? Imported Legacy Blogs 3
K Coding Standard vs Coding Guidelines vs Code Review Checklist Quality Assurance and Compliance Software Tools and Solutions 2
M Help with HTS Tariff code for NAFTA certificate Various Other Specifications, Standards, and related Requirements 1
A Coke Reactivity Index (CRI) Testing Code Interpretation: ASTM D5341-99 (2004) Various Other Specifications, Standards, and related Requirements 2
P Classification of Medical Device with Sub Code Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Description for GMDN Code wanted Other Medical Device and Orthopedic Related Topics 1

Similar threads

Top Bottom