Requirements for Humanitarian supply of Medical Devices to Jamaica

E

ElmerF

#1
Hello,

My company has been approached by a US physician that performs humanitarian medical procedures in Jamaica. Manufacturers provide him with medical devices free of charge. We would like to participate but I cannot find any information on the regulations for providing medical devices on a humanitarian basis. We have CE mark and our device is a class II 510K in US. We do not have any registration in Jamaica. What would we need to do from a regulatory perspective to provide these devices for charitable purposes?

Any advice appreciated.

Thanks,

ElmerF
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#3
Hello,

My company has been approached by a US physician that performs humanitarian medical procedures in Jamaica. Manufacturers provide him with medical devices free of charge. We would like to participate but I cannot find any information on the regulations for providing medical devices on a humanitarian basis. We have CE mark and our device is a class II 510K in US. We do not have any registration in Jamaica. What would we need to do from a regulatory perspective to provide these devices for charitable purposes?

Any advice appreciated.

Thanks,

ElmerF
You could supply the devices to the US physician in the US. The implementing party could then handle the transfer to Jamaica, with you supporting them with any required information.

In some countries a physician is able to import devices for own use (no distribution or commerce) without excessive registration.
 
Last edited:
E

ElmerF

#4
Thanks Guys. Sounds like we could supply the devices as initial use samples free of charge to the physician and that he would be responsible for any further registration after that.
 
Thread starter Similar threads Forum Replies Date
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
M Medical Devices Regulations and labelling requirements UAE Other Medical Device Regulations World-Wide 0
J Forging - Cracks requirements Manufacturing and Related Processes 17
O MDR language requirements EU Medical Device Regulations 12
R Does anyone know how ASQ exam requirements are verified? Professional Certifications and Degrees 3
J Bioburden requirements for Procedure Packs under Article 22? EU Medical Device Regulations 3
Sidney Vianna Informational Being developed ISO 30201 Human Resource Management System — Requirements Other ISO and International Standards and European Regulations 6
D PRRC requirements EU Medical Device Regulations 6
Q MSA requirements for IATF IATF 16949 - Automotive Quality Systems Standard 12
B AS9100 Certification Audit Accounting for Additional Customer QMS Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
P IEC 60601-2-25 requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
K Device part of combination product certification requirements Medical Device and FDA Regulations and Standards News 3
L "to be treated as APPLIED PART": is shopping in requirements allowed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W Incoming Certification Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Ed Panek ISO 13485 Reporting Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
D 8.3.2.1 Review of the Requirements for Products and Services. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Battery Labeling Requirements US Medical Device Regulations 0
D 8.2.3.1 Review of the Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Multisite Certification Requirements for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 8
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
B SAE J 524 Pressure Test/Possible conflicting requirements? Manufacturing and Related Processes 0
B Commercial requirements and outdated/superseded specs Various Other Specifications, Standards, and related Requirements 6
R Separation and PE Requirements of a Type B Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B IATF 16949 clause 10.2 - requirements following a customer complaint. IATF 16949 - Automotive Quality Systems Standard 9
S ISO 14001 Operational Planning and Control - Proving evidence of communicating environmental requirements to suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
M 8.4.1.1 Register of approved suppliers and requirements when they are customer-designated AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B Facility Weld Engineer Requirements Manufacturing and Related Processes 5
C Document Record/Template Minimum Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
G Labeling requirements for REFURBISHED medical devices EU Medical Device Regulations 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
H European requirements for rechargeable Lithium-ion batteries going to be used in Electronic Pipette CE Marking (Conformité Européene) / CB Scheme 0
C Regulatory requirements of cloud platform for devices developed in compliance with 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
Q EU Local Language Requirements for Operator Or User Manuals CE Marking (Conformité Européene) / CB Scheme 1
M BMW requirements for FMEA IATF 16949 - Automotive Quality Systems Standard 9
G MDR Requirements for Samples EU Medical Device Regulations 5
Q UK QMS Requirements UK Medical Device Regulations 2
V Review of the Requirements of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M IQ Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
Justanobody PAD printing and meeting regulatory requirements Manufacturing and Related Processes 10
M MDR Legal requirements EU Medical Device Regulations 6
M Labeling Placement Requirements according to the 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Judy Abbott Biocompatibility requirements for submission to Chile Other Medical Device Related Standards 1
S Additional registration requirements for different EU-states on top of standard CE-registration? EU Medical Device Regulations 3
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
J Old procedure review and training requirements Document Control Systems, Procedures, Forms and Templates 9
Quality Specialist AS9100D Approved Supplier List requirements and how to apply Supplier Quality Assurance and other Supplier Issues 11
D Halal - Returnable IBC Cleaning Requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0

Similar threads

Top Bottom