SBS - The best value in QMS software

Selling Class IIa medical device (sterile syringes) in USA

D

Denis

#1
Hi
We manufacture a Class IIa medical device (sterile syringes) for which we have a CE mark and technical file (based in the UK).

Are there any extra requirements needed to market and sell these devices in the USA.

The product is sold in Europe and UK and meets all the current regulatory requirements. Do we need some form of notification to the FDA and / or contact our notified body in the UK.

Any information would be greatly appreciated.
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
Re: Selling medical devices in USA

Hi
We manufacture a Class IIa medical device (sterile syringes) for which we have a CE mark and technical file (based in the UK).

Are there any extra requirements needed to market and sell these devices in the USA.

The product is sold in Europe and UK and meets all the current regulatory requirements. Do we need some form of notification to the FDA and / or contact our notified body in the UK.

Any information would be greatly appreciated.
You will need either a 510K approval or to prove that the product is exempt from approval. The FDA has a lot of guidance available at:

http://www.fda.gov/cdrh/devadvice/

Check it out. I would guess that syringes are not exempt from approval, but I am not an expert on FDA regulation.
 
#3
Thread starter Similar threads Forum Replies Date
B Selling Class IIa Medical devices in Albania Other Medical Device Regulations World-Wide 1
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
JoCam Buying and selling Class I and II medical devices EU Medical Device Regulations 1
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
M Class I Medical Device - Need to notify CA (Competent Authority) if selling in Asia EU Medical Device Regulations 4
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
I Requirements for selling Class I Medical Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 4
N Perfect Selling Fully Functioning Class 1 Medical Device vs. Antique ISO 13485:2016 - Medical Device Quality Management Systems 10
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 5
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Selling Clinical Practice Advice Other US Medical Device Regulations 7
I Selling medical gown and mask in China China Medical Device Regulations 0
M Selling Medical Devices in Puerto Rico US Food and Drug Administration (FDA) 3
K Selling Medical Device Components to US hospitals and doctors US Food and Drug Administration (FDA) 4
C Does the company violates any regulation/standard by selling device without warranty ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
T RISK: Selling Diagnostic Devices on Amazon Manufacturing and Related Processes 0
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
K Selling Medical Devices in Canada - Distributor? Private Label? Canada Medical Device Regulations 10
D Selling Medical Device Abroad After the Expiring Date of the EC Certificate EU Medical Device Regulations 5
S Selling Medical Demo Devices - is it allowable? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Selling with a Medical Device App EU Medical Device Regulations 4
T MDSAP readiness - Selling clinical product IVDs into Canada Canada Medical Device Regulations 7
T New to WEEE Directive - Selling a medical device directly to a professional end-user RoHS, REACH, ELV, IMDS and Restricted Substances 1
P Selling Medical Devices from the US into Israel Other Medical Device Regulations World-Wide 2
M Selling Medical Device DTC in FL - Need a license? Other US Medical Device Regulations 1
W Legality of selling parts by count - Counting Scales Quality Manager and Management Related Issues 6
B What is the FDA guidance regarding selling replacement parts and traceability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Selling Medical devices to Iran - OFAC doubts Other Medical Device Regulations World-Wide 6
D What are the requirements for selling Alcohol Swabs in USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Selling of Medical Power Supply in Australia/New Zealand and Japan Other Medical Device Regulations World-Wide 5
Marc LinkedIn Accused Of Secretly Selling Members Professional Data To Potential Employers World News 9
S Manufacturing and Selling Medical Devices with Used Components ISO 13485:2016 - Medical Device Quality Management Systems 3
C Selling of Research products in Europe EU Medical Device Regulations 9
G QMS - Selling the idea to the CEO! Quality Manager and Management Related Issues 8
S Regulations for Selling Convenience Kit vs. Selling Separate Parts Other US Medical Device Regulations 2
E Documentation for selling Prescription Only Medical Devices Other Medical Device and Orthopedic Related Topics 8
S Selling a CE Marked Product to a Hospital in Bulgaria Other Medical Device Regulations World-Wide 4
Ronen E ISO is Selling Draft Standards ISO 13485:2016 - Medical Device Quality Management Systems 7
Marc Boeing caught selling used parts as new to Pentagon (Oct 2013) World News 3
Q Internal Laboratory Services - Selling Services to "Outside" Customers General Measurement Device and Calibration Topics 1
M "Selling" the idea of using Work Orders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Selling Over the Counter Medical Devices in France EU Medical Device Regulations 3
Z Foreign Manufacturer selling in the US - Postmarket Surveillance question Other US Medical Device Regulations 2
P Selling Joint Implants without a Validated Process Manufacturing and Related Processes 8
R Selling Directly to Physicians in Turkey EU Medical Device Regulations 4

Similar threads

Top Bottom