FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

In our GMP News dated 29 August 2013, we reported about the activities of the successor organisation of the Global Harmonisation Task Force (GHTF): the International Medical Devices Regulators Forum (IMDRF). A working group of the IMDRF has been concentrating on a Medical Device Single Audit Program (MDSAP) and has elaborated appropriate working documents.

At the beginning of 2014, the FDA will participate in a MDSAP pilot programme together with the respective supervising authorities in Australia, Brasilia and Canada. Japanese supervising authorities will count among the further observers.

The idea behind this project is to allow acceptance of an audit performed by MDSAP recognized auditing organisations by all the parties participating in the programme. From June 2014 on, there should be appropriate audit organisations ready to perform audits within the pilot programme. During the pilot phase, organisations already registered in the "Canadian Medical Device Conformity Assessment System (CMDCAS)" programme will belong to the recognised audit organisations. Most of these organisations are also Notified Bodies according to EU regulations. A list of these organisations can be found on Health Canada's website. The audits should cover the corresponding regulatory provisions (ISO 13485:2003, the Brazilian GMP requirements for medical devices and 21 CFR 820). The pilot programme should end in 2016.

Further information can be found here.