In international trade, in the last decades, tariff and customs barriers have been gradually reduced or eliminated, but a new barrier has gradually developed, the regulatory barrier set up for products that can have an impact on the health of citizens, such as Medical Devices and In Vitro Diagnostic Devices.
For manufacturers who want to export their products in all markets, orienting themselves in this maze of regulations and laws is really difficult.
Only an in-depth knowledge of all the legal requirements of each country can lead to an integrated and optimized path to effectively support the commercial strategy, and this is only possible for companies havin true "Regulatory Affairs" specialists on their payroll.
Maytal is able to offer to the MD and IVD manufacturers an outsourced "Regulatory Affairs" service, which integrates specialized and regulatory technical skills to allow companies, even the smallest ones, to build a path that allows to quickly achieve the marketing of products in the most important markets in the world.

Medical devices

A Medical Device is any instrument, apparatus, Dispositivi mediciimplant, software, substance or other product used alone or in combination, including software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for the proper operation of the device, intended by manufacturer to be used on humans for the purposes of diagnosis, prevention, control, therapy or attenuation of a disease; diagnosis, control, therapy, mitigation or compensation of an injury or handicap; study, replacement or modification of the anatomy or of a physiological process; for intervention on conception, where a product does not exercise the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.
Medical Devices are considered to be:
  • an instrument (eg. surgical instrument)
  • a device (ECG, ultrasound, Rx, surgical laser, ultrasound for physiotherapy, etc.)
  • an implant (dental, orthopedic prosthesis, etc.)
  • a substance (eg certain types of creams, bone cements)
  • etc..

In vitro diagnostic devices

An in vitro diagnostic medical device Diagnostici in vitrois any device composed of reagents, reagent products, sets, instrument, apparatuses or systems used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body in order to provide information on physiological states or on health or disease or congenital anomaly.
In vitro diagnostic medical device is considered to be:
  • a reagent
  • a reactive product
  • a calibrator
  • a control material
  • a kit
  • an instrument
  • an apparatus
  • equipment or system