RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
  • Regulatory NewsRegulatory News

    IMDRF Takes Another Stab at IVDs, MDSAP

    Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...
  • Regulatory NewsRegulatory News

    Transition to ISO 13485:2016 Comes to an End

    The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization. Both the 2003 and the 2016 version of the global consensus standard—developed by the International Organization for Standardization (ISO—co-existed until Thu...
  • Regulatory NewsRegulatory News

    Canada Completes Transition to MDSAP

    Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit Program (MDSAP), according to Canada’s MEDEC. "We have been flooded with transition packages and we're going through all of them," Ian Sullivan, regulatory affairs specialist at Health Canada' Medical Devices Bureau, told Focus . The stack of transition packages has taken priority over calculating the final statistics on exact...
  • Regulatory NewsRegulatory News

    CDRH Touts Uptick in Foreign  Device Inspections

    The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report.   “As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries,” said Jeff Shuren, director at the FDA’s Center for Devices and Radiologi...
  • Regulatory NewsRegulatory News

    Health Canada: MDSAP Could Force Some Manufacturers Out

    With the approaching deadline for those in Canada to comply with the Medical Device Single Audit Program (MDSAP), Health Canada issued a notice to recognize that some device makers may be cancelling their licenses to avoid dealing with the new requirements. “It is anticipated that some manufacturers, instead of conforming to the new MDSAP requirements, may be cancelling their medical device licences and discontinuing the sale of their products as early as November 1, 201...
  • Regulatory NewsRegulatory News

    MDSAP Changes Aim to Reduce Audit Times

    With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits. The changes follow comments received by Health Canada from Canadian medical device license holders regarding the current audit-time model for MDSAP and subsequent annual survei...
  • Regulatory NewsRegulatory News

    MDSAP Update: Canada's 2019 Deadline Still on Track

    Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP). Background MDSAP is an effort by regulators in the Australia, Brazil, Canada, Japan and the US to establish a single audit process, conducted by recognized third-party auditors, that can meet the requirements of regulators in each country. For manufacturers, MDSAP ...
  • Regulatory NewsRegulatory News

    510(k) Third Party Review Program: FDA Offers New Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices. In an effort to encourage harmonization, the guidance refers to standards described in the International Medical Device Regulators Forum (IMDRF) documents as criteria FDA will con...
  • Regulatory NewsRegulatory News

    IMDRF Offers Progress Updates at March Meeting

    The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level. Background Originally launched as the Global Harmonization Task Force (GHTF) in 2012, the IMDRF is composed of regulators from Australia,...
  • Regulatory NewsRegulatory News

    FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

    The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA announced the changes in the Federal Register on Thursday, saying it "will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP." ISO 13485:2003 Submission Pilot In 2010, FDA released ...
  • Regulatory NewsRegulatory News

    MDSAP to Continue Past Pilot Phase in 2016

    Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday. MDSAP is the international consortium of five regulators from the US, Australia, Japan (which came on board in June), Brazil and Canada looking to tr...