secretsose.blogg.se

Republic of Korea's Ministry of Food and Drug Safety.

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT).The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme.United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA).Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency.Brazil’s Agência Nacional de Vigilância Sanitária.Therapeutic Goods Administration of Australia.International partners that are participating in the MDSAP include: The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.