On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia and the United-States.

The International Medical Device Regulatory Forum (IMDRF) published 5 information documents on the 2nd of October 2015:

  • IMDRF/MC/N34 Final: Statement regarding Use of ISO 14971:2007 “Medical devices – Application of risk management to medical devices”.
  • IMDRF/MC/N35 Final: Statement regarding Use of IEC 62304 ” Medical devices software – Software life cycle processes “.
  • IMDRF/MC/N36 Final: Statement regarding Use of IEC 60601-1 ” Medical electrical equipment – Part 1 : General requirements for basic safety and essential performance”.
  • IMDRF/MC/N37 Final: Statement regarding Use of ISO 10993-1 «  Biological evaluation of medical devices – Part 1 : Evaluation and testing within a risk management process “.
  • IMDRF/MC/N38 Final: Statement regarding Use of ISO 11137-1 : 2006 ” Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices “.

Included in these documents are tables describing the application of standards in the countries, or group of countries, which are members of the IMDRF: Australia,  Brazil, Canada, China, Europe, Japan, Russia and the United-States.

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