International Sales Legal/Regulatory Gray Area?

I

IHeartRegs

#1
#1
Hi, all. I'm a frequent lurker and know this is a good site to gain a broad perspective on issues. Hoping for that with this one!

If a contract for a medical device (not yet FDA registered or ISO certified) specifies a certain percentage of down payment for international sales (without delivery of product) 30-45 days before shipment of product (at which time the remainder would be paid, and would not occur before the CE mark is obtained), can the down payment be legally accepted before the CE mark is obtained?

Regardless of the answer, would you mind sharing the criteria/standard/precedent for the decision? Or, if you can't answer, even being pointed in the right direction to research the applicable laws/regulations myself would be enormously helpful. We're trying to educate ourselves.

Looking forward to some help/direction.:) Thanks!
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Wes Bucey

Wes Bucey

Prophet of Profit
#2
#2
Re: Legal/Regulatory Gray Area?

IHeartRegs said:
Hi, all. I'm a frequent lurker and know this is a good site to gain a broad perspective on issues. Hoping for that with this one!

If a contract for a medical device (not yet FDA registered or ISO certified) specifies a certain percentage of down payment for international sales (without delivery of product) 30-45 days before shipment of product (at which time the remainder would be paid, and would not occur before the CE mark is obtained), can the down payment be legally accepted before the CE mark is obtained?

Regardless of the answer, would you mind sharing the criteria/standard/precedent for the decision? Or, if you can't answer, even being pointed in the right direction to research the applicable laws/regulations myself would be enormously helpful. We're trying to educate ourselves.

Looking forward to some help/direction.:) Thanks!
Click to expand...
My "weasel mind" says YES - I would consider it the same as prepayment in full for a custom product, subject to refund if the product does NOT achieve CE status.

The governing criterion is the refund if CE not achieved. Obviously, the product is NOT delivered until CE status achieved.
 
CharlieUK

CharlieUK

Quite Involved in Discussions
#4
#4
I don't see any issue with part payment

A product must be CE marked before it is "placed on the market" or "put into service" and neither of these have been done.

This sounds like purely a contractual requirement where intent to buy is confirmed with part payment and transfer of ownership has not occurred.

Charlie
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
H Medical Devices Regulatory Intelligence for International Markets ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna IAQG News Designation of aerospace standards to be modified - from AS91X0 (in the Americas) to IA91X0 (International Aerospace) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Cats Clause Certified Quality Systems Ltd (CQS) accredited by International Accreditation Board Registrars and Notified Bodies 4
N ISCC Plus - The international Sustainability Carbon Certification Sustainability, Green Initiatives and Ecology 2
Z E-Coating process International Specifications? FMEA and Control Plans 3
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
Sidney Vianna Informational IAF and ILAC Seek Contractor for Establishment of a Single International Organization for Accreditation ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
M Class I - International Registrations EU Medical Device Regulations 3
E Packaging Specifications Mercedes-Benz U.S. International IATF 16949 - Automotive Quality Systems Standard 4
F Mig Welded Components - IMDS International Material Data System RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Medical Device News International exposé of the harm caused by poorly tested medical devices. Other Medical Device Regulations World-Wide 12
Wes Bucey International Manufacturing Technology Show - 10 September 2018 - Chicago (meet up?) Coffee Break and Water Cooler Discussions 6
Sidney Vianna Optimizing Standards for Regulatory Use - International Medical Dev. Regulators Forum Other Medical Device Regulations World-Wide 0
qualprod Which standard to follow, local or international? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
N International / Traceable Standards - Procedures for Calipers, Micrometers, Etc. ISO 17025 related Discussions 2
B ISO 17100 (Requirements for Translation Services) International Translations Other ISO and International Standards and European Regulations 4
S Where is a good place to get IMDS (International Material Data System) Training? IATF 16949 - Automotive Quality Systems Standard 3
Marc IAF (international accreditation forum) - Mandatory Documents (MD Series) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
Marc "Elsmar 90" International Quality Standard anyone? Other ISO and International Standards and European Regulations 33
F Future Plan for IMDS (International Material Data System) RoHS, REACH, ELV, IMDS and Restricted Substances 5
J International Standards governing Test Method Validations ISO 13485:2016 - Medical Device Quality Management Systems 1
R Determination of IP (International Protection Marking) Rating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
U ISO 9001 Certification for Highly Distributed International Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Calibration Procedure Traceable to National/International Standards (API Q1 9th Ed) Oil and Gas Industry Standards and Regulations 3
M Basic International Standards required for a Manufacturing Industry (Optical Media) Other ISO and International Standards and European Regulations 4
M Differences between international and regional standards (EN, AAMI, CSA...) Other Medical Device Related Standards 6
D International Standards (ISO or MIL) for MTBV Reliability Analysis - Predictions, Testing and Standards 4
automoto International Problem Solving Guide Problem Solving, Root Cause Fault and Failure Analysis 2
AnaMariaVR2 The International Pharmacopoeia (Ph. Int.) WHO US Food and Drug Administration (FDA) 1
M FDA Acceptance of ISO 13485 Reports from a Recognized International Program Other US Medical Device Regulations 4
I International Accreditation Board of Bristol, UK ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
Jen Kirley This international consultant thing sure is a ride! Career and Occupation Discussions 13
S IATF (International Automotive Task Force) Rules 4th edition changes IATF 16949 - Automotive Quality Systems Standard 1
P IMDRF (International Medical Devices Regulators Forum)guidance on standalone software Medical Information Technology, Medical Software and Health Informatics 1
J Rayong Thailand - Best Hotel and closest international Airport Travel - Hotels, Motels, Planes and Trains 3
J Domestic and International Medical Device IFU (Instructions for Use) Other US Medical Device Regulations 3
E Are non-SI units International? General Measurement Device and Calibration Topics 7
S The days before International Standards - Has ISO done what it was supposed to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D RABQSA International (SUSPENDED) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Icy Mountain Combining ISO9001 and ITAR (International Traffic in Arms Regulations) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Measurement Standards Traceable to International or National Measurement Standards AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B What a mess!!! Nebula Glass International (d.b.a. Glasslam) vs. Wacker Chemicals Quality Manager and Management Related Issues 1
T International Medical Data Storage Requirements Other Medical Device Regulations World-Wide 4
H Painting Quality Requirement International Standard Manufacturing and Related Processes 6

Similar threads

Top Bottom