Showing items tagged as MDSAP

  • Top Regulatory Trends Affecting Med Dev in Asia-Pacific Moving into 2019

    26 February, 2019 by Grant Bennett, CEO, Brandwood Biomedical

    Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.

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  • 2019 Med Device Trends to Watch For: Regulatory Changes

    14 February, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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  • 5 Keys to Helping Your Device Company Gain MDSAP Certification

    2 January, 2019 by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

    The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.

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  • MDSAP: Guiding Your Company Through the Audit Process

    26 December, 2018 by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

    Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.

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  • FY2018 Increasing User Fees Affects Submission Strategy

    11 October, 2017 by Michelle Lott, Founder, Lean RAQA Systems, LLC

    Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

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  • 2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

    2 March, 2017 Marci Crane, Staff Writer, MasterControl

    For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of

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