News about GMP/cGMP


How is the harmonisation of ISO 13485 and US 21 CFR 820 going?

The United States FDA works on the harmonisation of the Quality System Regulation, 21 CFR 820 with ISO 13485, the international standard for quality management of medical devices (we reported), saying that

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”

In September 2019, the Association for the Advancement of Medical Instrumentation (AAMI) published a technical information report to smoothen transition for the medical device industry.
The initial goal was, to use ISO 13485 already in April 2019. Now the date has been shifted towards the end of this year as the transition is still in the rule stage.

What are the benefits of the upcoming harmonisation?

  • With ISO 13485:2016 being  more up-to-date than 21 CFR 820, the American system will be modernised.
  • Working globally will become easier.
  • With already many similarities between the two guidelines a smooth transition is expected.
  • ISO 13485:2016 has already been accepted as single audit program in Australia, Brazil, Canada and Japan.


Office of Information and Regulatory Affairs: Harmonizing and Modernizing Regulation of Medical Device Quality Systems

Association for the Advancement of Medical Instrumentation: AAMI TIR102:2019