The Medical Device Single Audit Program
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The Medical Device Single Audit Program

In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration. On January 1, 2015, the MDSAP pilot program was opened to manufacturers around the…

Whitepaper – ISO13485 & US FDA CFR 820 Comparison
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Whitepaper – ISO13485 & US FDA CFR 820 Comparison

Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the…

TGA Launches Pilot of Medical Device Single Audit Program
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TGA Launches Pilot of Medical Device Single Audit Program

The Therapeutic Goods Administration (TGA) launched the Medical Device Single Audit Program (MDSAP) pilot program, starting from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration (USFDA). The TGA and MDSAP participation The MDSAP is designed to ensure a single audit of a medical…