J. Mitra & Co. Pvt. Ltd. Warranty

Listing Results J. Mitra & Co. Pvt. Ltd. Warranty

Frequently Asked Questions

• What is an in vitro device?

  equipment or system intended for use in vitro to examine specimens including blood and tissue donations from the human body Other examples of in vitro devices are blood grouping reagents, pregnancy test kits and Hepatitis B test kits. See further guidance on the legislation relating to in vitro diagnostic devices for further information.

• What is the in-vitro diagnostic devices regulation 2017/746?

  The In-Vitro Diagnostic Devices Regulation ( Regulation (EU) 2017/746) will apply from 26 May 2022, following a five-year transition period. In the meantime, manufacturers can opt to place in-vitro diagnostic devices on the market under Directive 98/79/EC or under the new Regulation if they fully comply with it.

• What are the regulations for manufacturers of medical devices?

  Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.

• What is medical devices?

  Medical devices. Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Medical Devices and the In-Vitro Diagnostic Devices Regulations have introduced new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment ...