ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

24^th September, 2026

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY (TMDA) HAS OFFICIALLY BECOME AN AFFILIATE MEMBER OF THE MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

1. Tanzania has officially become an Affiliate Member of the Medical Device Single Audit Program (MDSAP), marking an imperative landmark in the country’s continued efforts to strengthen its medical device regulatory systems and align with Internationally recognized regulatory practices.
2. Considering the rapid pace of technological advancement and innovation globally, membership as an MDSAP Affiliate provides Tanzania with an opportunity to engage more closely with the International medical device regulatory community and to benefit from the experience, knowledge, and regulatory practices developed through MDSAP. Through this participation, Tanzania will strengthen the capacity of its regulatory systems and enhance understanding of internationally harmonized approaches to medical device quality management systems and regulatory oversight thereby building global confidence in TMDA regulatory framework and strengthening Tanzania’s position as a trusted regulatory authority in the global medical technology arena.
3. As an MDSAP Affiliate Member, the Tanzania Medicines and Medical Devices Authority (TMDA) will have access to official MDSAP audit reports and relevant Quality Management System (QMS) certification information from participating manufacturers. TMDA will also have access to the MDSAP participating facility directory, which shares important information on manufacturing sites, audit dates, and the responsible MDSAP Auditing Organizations (AOs).
4. Access to this information will significantly strengthen TMDA’s ability to conduct efficient and effective desk reviews of manufacturers’ QMS compliance. By leveraging MDSAP audit outcomes and existing regulatory information, TMDA can reduce unnecessary duplication of regulatory audits, optimize the use of regulatory resources, and streamline the assessment of medical device manufacturers. Ultimately, this will contribute to more efficient regulatory decision-making and timely access to safe, effective, and high-quality medical devices for the Tanzanian population, while maintaining appropriate regulatory oversight and protection of public health.