SBS - The best value in QMS software

Labeling Requirements - Creams in tubes

tiptoe

Starting to get Involved
#1
Hi there,

I need some assistance. As an example: A company manufactures Class IIa medical devices in a form of creams in tubes package in blisters. The blisters are packaged in boxes as a set of 20 blisters/box as a unit and not sold individually. The boxes are then put into a case (10 boxes per case). The box has appropriate labeling symbols on them which includes the symbol for expiration, lot and also a UDI code. My question is, is the individual blister required to have the lot and expiration symbol on it as well? Note, the blister also has the UDI code with the other applicable symbols printed on the blister lid/backer. Thank you
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
I would think so.. the client might discard the box and lose track of the individual blister expiration date. Also, as I imagine, you could have mixed lots in the same box.
 

tiptoe

Starting to get Involved
#3
I would think so.. the client might discard the box and lose track of the individual blister expiration date. Also, as I imagine, you could have mixed lots in the same box.
If the blisters contained are of the same lot, will that make any difference in your response? Thank you
 
Thread starter Similar threads Forum Replies Date
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
I Requirements for different Labeling Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J FDA regulations vs. IEC 60601-1 Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
J ITA (Investigational Testing Authorizations) - Labeling requirements Canada Medical Device Regulations 1
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Labeling requirements for procedure pack 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Labeling Requirements for Acquired Medical Device Inventory Other US Medical Device Regulations 2
B Labeling requirements for Servicing and Repairing Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
JoCam Labeling Requirements for Medical Devices Made in China EU Medical Device Regulations 6
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
G Labeling requirements for individual units for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
B Labeling requirements of Alcohol (Isopropanol) Swabs EU Medical Device Regulations 3
S GHS Labeling Requirements question Occupational Health & Safety Management Standards 6
Q CE-Labeling requirements: Year of manufacture for Software EU Medical Device Regulations 3
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
J Medical Device Labeling and Symbols - US and EU Requirements CE Marking (Conformité Européene) / CB Scheme 6
D Automotive Labeling Requirements for LH and RH Parts IATF 16949 - Automotive Quality Systems Standard 4
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
R Labeling, translation requirements including software interface: EU & other markets EU Medical Device Regulations 2
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
N Labeling Requirements for Medical Devices in Hong Kong Other ISO and International Standards and European Regulations 2
Y Labeling requirements for X-ray detector Other US Medical Device Regulations 1
S Class I Device - Reusable Instruments labeling requirements Imported Legacy Blogs 2
J IEC 60601 Third Edition Labeling Requirements - Section 5.2.2.1 (g) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Measurement Equipment Shelf Rack Labeling Requirements question General Measurement Device and Calibration Topics 5
N DEHP/DHP Labeling Requirements TGA Other Medical Device and Orthopedic Related Topics 2
T IEC 60601 3rd Labeling Requirements and Software GUI IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Thailand Medical Device Labeling Content Requirements Other Medical Device Regulations World-Wide 3
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
W Calibration and Measuring Device Labeling Requirements Quality Manager and Management Related Issues 4
Y Medical Device Accessory Labeling Requirements Other Medical Device Regulations World-Wide 1
L Labeling Requirements in Part A Class IIb Medical Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
T Requirements for Private Labeling a Class III (PMA) Medical Device in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Indian Labeling Requirements for Imported Medical Devices Other Medical Device Regulations World-Wide 9
L Medical Device Battery Labeling Requirements in the US US Food and Drug Administration (FDA) 1
J Own Brand Labeling NB (Notified Body) requirements EU Medical Device Regulations 3
M 21CFR820.120 Device Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T FDA Labeling Requirements Vs Health Canada Requirements Other US Medical Device Regulations 5

Similar threads

Top Bottom