UK Responsible Person for Medical Devices According to current UK regulations, the only way for non-UK manufacturers to sell their devices in the United Kingdom is through the use of a UK Responsible Person. The UKRP must be based in the UK and conduct specific duties on behalf of the manufacturer, such

FDA US Agent We provide US FDA Agent Services across the Globe. The United States Food and Drug Administration (USFDA) enforces the need for foreign-based Food, Drug, and Medical Device companies without a location in the United States to register with the FDA after

Medical Device Manufacturers that do not have a physical location in Europe must appoint a EU Authorised Representative located within Europe.

EN ISO 10993-18 ( CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE )     Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractable and leachable) which could disclose biological risks to patients and medical practitioners. Extractables are substances that can be…

The 510k submission is also known as a Pre-market Notification. This includes technical, performance, and safety information about the medical device.

As per food and drugs' regulation manufactures, initial exporters, and initial importers must complete Medical Device FDA Registration.