Medical Device Transportation Regulations

T

tabikkat22

#1
Hello Group!
I was wondering if anyone could direct me to transport regulations around medical devices. As far as my research between 21CFR and WHO I can find nothing specific stating that the transport company must be a qualified/certified vendor and what the qualification/certification standards might be.

If there is such a standard for the shipping/transport process. Please pass the information along my way.

I appreciate the assistance.

Have a blessed day!

In light,
Tabikkat:)
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
No such regulations exist, to my knowledge. Regulation instead is product focused, i.e. ISO 11607 requires that the product packaging must be validated to perform adequately for the intended shipping method and particulars.
 

Ajit Basrur

Staff member
Admin
#3
Hello Group!
I was wondering if anyone could direct me to transport regulations around medical devices. As far as my research between 21CFR and WHO I can find nothing specific stating that the transport company must be a qualified/certified vendor and what the qualification/certification standards might be.

If there is such a standard for the shipping/transport process. Please pass the information along my way.

I appreciate the assistance.

Have a blessed day!

In light,
Tabikkat:)
Welcome to the Cove :bigwave:

In addition to what MIREGMGR has posted, have a look at this link too - http://elsmar.com/Forums/showpost.php?p=243371&postcount=4
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hello,

It's up to you to analyse and determine whether there might be any significant impact of shipping conditions (e.g. particulate contamination, spillage effects, temperature (extremes as well as cycling effects), humidity, mechanical impact, vibration etc.) on any critical characteristics of the device, including packaging & labeling. If there may be any, it would point you in relevant directions regarding supplier qualification requirements and applicable standards.

If you determine that there may be such significant impact on critical device characteristics, then the shipment service becomes a critical input to your process, and the selection and qualification of service supplier subject to Purchasing Controls under part 820. Similar regulation / requirements would be similarly applicable in regulatory territories other than the USA (e.g. ISO 13485).

You may also want to look at applicable local regulations regarding transportation of dangerous goods, if your device contains any.
 
Last edited:
Thread starter Similar threads Forum Replies Date
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
K Li Ion battery for medical device: transportation safety Other Medical Device Related Standards 2
lilybef A standard that gives requirements for medical device transportation studies? Other ISO and International Standards and European Regulations 6
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom