MDSAP: unifying monitoring of medical device manufacturing

The MDSAP aims to create a harmonised, global approach to auditing and monitoring of medical device manufacturing. This approach could be of huge benefit to medical device companies as it allows them to expand easily into new markets, but how wide is its scope? As of 1 January 2019, regulator Health Canada has mandated that all manufacturers wanting to sell medical devices in the country must adhere to the Medical Device Single Audit Programme.
The MDSAP was formulated by the International Medical Device Regulators Forum (IMDRF) following a meeting in Singapore in 2012 of regulatory representatives from the major medical markets and the World Health Organization (WHO). The regulators were responding to the ever-changing demands of a developing sector and building upon the work of IMDRF’s predecessor the Global Harmonization Task Force (GHTF), a voluntary group of representatives formed in 1992.