Do you want the world to see your dirty laundry? If not, then EMMA International can help you prepare for the new Medical Device Single Audit Program (MDSAP). MDSAP full implementation is in effect as of January 1, 2017.
The Medical Device Single Audit Program will soon be mandatory if you sell medical devices in the following markets: Canada, USA, Brazil, Japan or Australia.
The MDSAP will be both a time and cost savings for companies. Medical device manufacturers will be able to have one single quality system audit that would encompass the five markets below vs. having to complete five separate audits. The MDSAP will cover all country specific requirements for:
• Therapeutic Goods Administration of Australia
• Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• US FDA
One single audit report will be shared among all the participating authorities. Each market will no longer hold their market audit report confidential. MDSAP reports will be accepted by FDA as a substitute for routine FDA inspections.
How does your QMS laundry list look? Think about how solid is your CAPA system, Complaint handling, purchasing controls. Is your internal audit schedule current and in compliance with your QMS?
Do you want the world to see your dirty laundry? If not, then have EMMA International perform pre-audit review of your quality system to prepare you for the official MDSAP audit.
Time is running out! The Pilot program is already over. Only MDSAP certificates will be accepted by Canadian regulators after 31 December 2018.