Medical Device ISO 14971 Risk Management Training Services.

MDSAP, Medical Device Single Audit Program MDSAP is a third party audit and assessment programme developed by the IMDRF organisation in 2014 to improve the safety and surveillance of medical devices for trade, resources and services. The aim is to achieve uniform recognition among different MDSAP member countries (TGA Australia, ANVISA Brazil, FDA USA, HC Canada, MHLW & PMDA Japan) through a single audit process.

When a product is determined to be a medical device in Canada, it is necessary to submit information to Health Canada (Health Canada) for registration; it is worth noting that it is sufficient to apply for an MDEL for Class I medical devices in Canada, and an MDL for Class II, Class III, and Class IV (the applicant must have a certificate of MDSAP accreditation).