14/08/2022 Other Services
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the FDA. However, additional requirements apply.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
https://www.usfda.info/medical-devices/
Understanding and complying with country registration requirements is essential for successful market entry and ensuring the safety and efficacy of me...
CDSCO Registration is mandatory to approve and regulate pharmaceuticals and medical devices in India, overseen by the Central Drugs Standard Control O...
Operon Strategist offers specialized validation documentation consulting services for medical device companies in Costa Rica. Our experts ensure compl...
To register a medical device for manufacture, submit an application to the CDSCO together with the necessary documentation, which includes device deta...
More Details