Regulatory requirements for secondary packages in terms of label content

#1
Dear members
I am looking for specific regulatory requirements for secondary packages in terms of label content.
it is clear what should go on the device itself in terms on label content, yet what is the rule on any other layer of packages (except UDI which is clearly defined)? Should any level of packaging (say a carton box containing 10 devices) reflect the devics inside to the level of serial number?

Can you help providing references for US, Canada and EU?

Thank you all
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#3
Hi Guy,
With most medical devices the labelling regulation do not go beyond the primary packaging. Requirements for secondary packaging are rare and are product specific. For example, the FDA has specific requirements for container and package (carton) label when it comes to Biological Products.

When there is no regulatory requirements from your secondary packaging, you should consider QA needs (e.g. storage conditions), distributor needs and customs needs. Most manufacturers just put everything on every label, but this approach of "overkill" is inefficient.

Cheers,
Shimon

P.S. Say 'hi' to Judith from me :)
 
Thread starter Similar threads Forum Replies Date
N Medical Device Secondary Packaging Facility - Regulatory Compliance Requirements? EU Medical Device Regulations 2
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A GPS Regulatory requirements? Manufacturing and Related Processes 6
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
E Regulatory Requirements for Exporting Medical Devices to Bonaire EU Medical Device Regulations 1
pcoltsqe AS9100 - The statement 'applicable statutory and regulatory requirements' AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Legal or Regulatory Requirements as identified in our Environmental Aspects ISO 14001:2015 Specific Discussions 9
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
J MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US ISO 13485:2016 - Medical Device Quality Management Systems 3
Q IATF 16949 Cl. 4.4.1.1, 8.4.2.2, 8.6.5 - Statutory and Regulatory Requirements IATF 16949 - Automotive Quality Systems Standard 6
N ISO 13485 - Other Documentation specified by Applicable Regulatory Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
K Country/region specific medical device regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
T Statuatory and Regulatory requirements related to product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R IVD regulatory requirements for different hospital environments Other Medical Device and Orthopedic Related Topics 1
J What are the regulatory requirements to sell a Class II Medical Device in USA? Other US Medical Device Regulations 7
apestate How to determine all regulatory and statutory requirements to be met? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J RA (Regulatory) Requirements for Outsourced Call Centers Supplier Quality Assurance and other Supplier Issues 3
E INDONESIA: Regulatory Requirements for Veterinary x-ray equipment Other Medical Device Regulations World-Wide 2
E BRAZIL: Regulatory requirements regarding aids for invalids Other Medical Device Regulations World-Wide 3
E TURKEY: Regulatory requirements regarding aids for invalids Other Medical Device Regulations World-Wide 2
G Guidance on Automotive Regulatory Requirements IATF 16949 - Automotive Quality Systems Standard 4
J Regulatory Requirements for Prefilled Syringes Company EU Medical Device Regulations 10
A Clean Room Qualification Regulatory Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M Any new or revised EU or FDA regulatory requirements for IVD diagnostics in 2013? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Regulatory Requirements for telehealth or telemedicine in India Other Medical Device Regulations World-Wide 2
E Regulatory Requirements for Distributors of Medical Devices Other Medical Device Regulations World-Wide 6
G Device Output (Reports) - Any regulatory requirements? US Food and Drug Administration (FDA) 4
C Bulgarian regulatory requirements for export of class IIb medical devices EU Medical Device Regulations 4
S Please help me define training requirements for a Career in Regulatory Affairs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G AS9100 - Clarify what is meant by Statutory & Regulatory Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Requirements for Regulatory Binders for the Medical Device Field 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
JoCam EASA Regulatory Requirements for Electronics Contract Manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M 7.4.1.1 Statutory & Regulatory Conformity: Legal Requirements of which Country? IATF 16949 - Automotive Quality Systems Standard 4
K Should project managers know what basic regulatory requirements are? Internal Auditing 17
S Regulatory requirements for Commercial Medical Devices for sale in Europe ISO 13485:2016 - Medical Device Quality Management Systems 2
J Medical Software Regulatory Requirements for South America and Middle East Other Medical Device Regulations World-Wide 3
D 510(k) Medical Device Classification and Regulatory Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M AS9100 4.1 How can I know/monitor applicable regulatory/statutory requirements? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Regulatory Requirements for for Class IIa Electro Medical Devices for South America Other Medical Device Regulations World-Wide 4
L Regulatory Requirements for Medical Devices (Standalone-software) in Brunei Other Medical Device Regulations World-Wide 3
S Regulatory Requirements for Telehealth or Telemedicine in South Korea Other Medical Device Regulations World-Wide 1
somashekar About ISO9001 Scope and Applicable Statutory and Regulatory Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
E What's your opinion on the regulatory requirements of Mexico? Other Medical Device Regulations World-Wide 3

Similar threads

Top Bottom