Shipment of a CE Approved Class III Device to the EU Member States

#1
I am hoping that a subject matter expert can provide some advice. I am with a medical device start-up company in Irvine that recently received CE approval for 2 products, both Class III. We are registered with the FDA as an exporter. I was advised that I would also need to obtain a Certificate of Exportability from the FDA. After going through the application process, the FDA rejected the request citing the fact that we have not had an FDA inspection. We are a few years away from USFDA approval and the need for an FDA site inspection. I would appreciate the advice from anyone that may have had a similar experience and what the workaround was. Your advice is very much appreciated.

Best Regards,
Steve P
 
Last edited:
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A DCMA inspection for a drop-shipment AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
Z PFMEA Detection Controls and Ranking - Prevent Shipment FMEA and Control Plans 3
V EMEA/UK cGMPs Requirements for Pre-Shipment Samples, Input Materials US Food and Drug Administration (FDA) 0
J Packaging Specification Needed - Packaging for Shipment and Storage of Product AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
D Product Shipment without Signed PSW - Customer does not provide signed PSW to us APQP and PPAP 13
M Oxygen Data Logger that we can place with each shipment via aircraft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Chris Ford Certificate of Conformity (for a shipment) Document Control Systems, Procedures, Forms and Templates 3
CalRich Requirement from the PPAP Manual or from GM to add a PPAP Report with Shipment? Customer and Company Specific Requirements 1
C Shipping Validation Standard for International Shipment Other Medical Device Related Standards 3
hogheavenfarm Whose job? What department schedules a PSI (pre shipment inspection)? Quality Manager and Management Related Issues 6
A CE Marking: Date of Manufacture or Date of Shipment EU Medical Device Regulations 1
D Shipment made to Canada have to be on heat treated pallets or skids Other ISO and International Standards and European Regulations 7
W Device History Record - Post Shipment - Class II Medical Device w/ Embedded Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Huh? What is "Stop Shipment Notification" IATF 16949 - Automotive Quality Systems Standard 6
H Drop Shipment Verification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Preventive Action - Mislabeling of Cargo Shipment Preventive Action and Continuous Improvement 5
D Certified shipment does it mean every part has to be checked 100%? Nonconformance and Corrective Action 12
J QS 9000 Element 4.15 ( 4.15.6.4 Shipment Notification System) QS-9000 - American Automotive Manufacturers Standard 2
M Shipment Notification System QS-9000 - American Automotive Manufacturers Standard 3
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
Ajit Basrur Why is ISO 14644-3:2019 not approved by US? Other Medical Device Related Standards 1
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
J Change management with CFDA approved devices China Medical Device Regulations 1
J Dr Training Records - Training doctors to use a PMA approved medical device Other US Medical Device Regulations 2
L CQI & IRCA not accepting new applications for ATPs (Approved Training Partner) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
Jane's Should the facility landlord be an approved supplier? Supplier Quality Assurance and other Supplier Issues 12
I Adverse Event Reported during Non-Approved Indication Use EU Medical Device Regulations 4
F Scientific and Research Papers for Foreign Approved Devices Other US Medical Device Regulations 1
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
J FDA approved Medical Devices for PVD and DLC Coatings US Food and Drug Administration (FDA) 2
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
J Why Control Plan Review needs to be Approved by the Customer IATF 16949 - Automotive Quality Systems Standard 1
F China Medical Device Labeling - Not approved for use, is for an exhibition EU Medical Device Regulations 4
S API Q1 Approved Training & Professional Certification Sources Oil and Gas Industry Standards and Regulations 5
gunnyshore Benchmarking: Approved Supplier List for Multiple Sites Supplier Quality Assurance and other Supplier Issues 2
S Why Drugs and generics are Approved while Biologics are Licensed ? US Food and Drug Administration (FDA) 1
L Do HR consultants need to be on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 5
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Similar threads


















































Top Bottom