Medical Device Initial Importer (DII) Requirements - Delivery Address

SGquality

Quite Involved in Discussions
#1
I have a question on Device Initial Importer (DII) - could this be the entity responsible for the importing device into the US (Importer of Record) or it has to be the physical address where the goods are being delivered to?

The disadvantage with registering the physical address is that the Corporation has to do multiple registrations but if the Corporation registers as DII, the devices could be imported anywhere in the US?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
W Contract Initial Importer and Order Handling for a Class I Medical Device Service Industry Specific Topics 2
M Initial Inspection of Medical Device Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 3
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 2
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 0
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
Q 21 CFR 821 Medical Device Tracking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Discontinuation of the Predicate Medical Device Medical Device and FDA Regulations and Standards News 1
H Online courses/program for medical device regulation EU Medical Device Regulations 4
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 8
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 8
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
S How to register class IIA medical device accessories EU Medical Device Regulations 1
D 3 Companies - Medical device parts and substances - Responsibilities EU Medical Device Regulations 4
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
U Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden Other Medical Device and Orthopedic Related Topics 2
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
R Medical Device Airworthiness, DO-160 Test Planner IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Are Eye drops made in China classified as medical device in China? ISO 13485:2016 - Medical Device Quality Management Systems 0
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
J Medical Device Components US to EU commercialization EU Medical Device Regulations 7
S Medical device storage conditions Other Medical Device and Orthopedic Related Topics 1
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
Similar threads


















































Top Bottom