MDSAP- Don’t Let the World See Your Dirty Laundry

by | Jan 25, 2017 | Medical Devices

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.


Emma International

Emma International

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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