What is the FDA Registration number?FDA Registration number provided by FDA soon after the confirmation of registration. This is applicable Read More

The person responsible for regulatory compliance (PRRC) is not intended to take the place of a European Authorized Representative (EC Read More

Device name: Peripheral Vascular Catheters MDR 2017/745: Class: Class III, Rule 8: Implantable device and long term surgical invasive device Read More

The animal testing utilized for the assessment of the medical devices initial evidence of device safety, their potential performance when Read More

Clinical Information system means all data, reports, writings, research, and calculations performed using a medical device in scope. Output is Read More

UKCA Mark or a CE Mark logo is a must depending on which legislation the device has been certified under. Read More

EU Registration for Face Masks: face masks usually fall into two categories – Medical Face Masks and Respirators. Medical Masks Read More

EU Registration for Gloves: Examination Gloves fall under the Class I category of Medical devices intended for use in the Read More

Class I Medical Device EU Registration : If a manufacturer plans to market their product in the EU market, the manufacturer Read More