MHRA Announces Intention to Join MDSAP

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to move towards full membership of the Medical Device Single Audit Program (MDSAP), the international scheme that allows a single quality management system audit to satisfy the regulatory requirements of multiple participating regulatory agncies.

At present, MHRA is an official observer of MDSAP, and if it progresses to full membership, it would join a number of regional regulators, including the US FDA, Health Canada, PMDA (Japan), TGA (Australia) and ANVISA (Brazil).

The UK Industry Association ABHI has welcomed the announcement, as “greater use of MDSAP in the UK has the potential to support a more aligned and proportionate regulatory approach,” continuing: “For the HealthTech industry, voluntary use of MDSAP could allow audit data reuse, reduce duplication across jurisdictions, and support greater international alignment on post-market surveillance.”