SBS - The Best Value in QMS software

Requirements for Exporting Class III Medical Devices into the UAE from the US or EU

R

regina_q

#1
Does anyone have links or knowledge around exporting Class III medical devices into the UAE from the US or EU? I know the requirements have changed since I last checked in 2008. Thx.
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
Re: Requirements for Exporting Class III Medical Devices into the UAE from the US or

A quick 'bump'. If any of you folks can help with this, my Thanks in advance!
 
R

Ryan Leslie

#3
Re: Requirements for Exporting Class III Medical Devices into the UAE from the US or

QUICK BUMP

Anyone here know anything, I am looking for this information.

Thanks
 
Thread starter Similar threads Forum Replies Date
K Requirements for Exporting from US to EU - Class I MD non-sterile, non-measuring EU Medical Device Regulations 7
E Regulatory Requirements for Exporting Medical Devices to Bonaire EU Medical Device Regulations 1
J Exporting Add-On for Medical Devices to the US - FDA Requirements Other Medical Device Related Standards 3
S Pre-Approval Requirements - Exporting Medical Devices to China from the US China Medical Device Regulations 4
B Requirements for Exporting Medical Devices to Libya Other Medical Device Regulations World-Wide 5
B Requirements for Exporting Medical Devices to Australia Various Other Specifications, Standards, and related Requirements 25
B Requirements for LiPo Batteries in the EU ? CE Marking (Conformité Européene) / CB Scheme 5
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Gauge Management - with ambiguous requirements & no support ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
K IATF audit day requirements table 5.2 IATF 16949 - Automotive Quality Systems Standard 6
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
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
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Composites - Freezer sensor requirements Manufacturing and Related Processes 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0

Similar threads

Top Bottom