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Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That's why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you'll enjoy the content.

US FDA to Require Proof of IEC 60601-1 3rd Edition in Summer 2013
May 16, 2013 by Stewart Eisenhart | Filed under Market: USA
The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.
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Australian Regulators Propose Changes to IVD Oversight Plan
May 15, 2013 by Stewart Eisenhart | Filed under Market: Australia
Australia’s Therapeutic Goods Administration (TGA) has published proposed changes to upcoming in vitro diagnostic (IVD) regulations for comment ahead of a proposed final implementation date of July 2014. High-level components of the new Australian IVD regulatory scheme include:
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Chinese Regulators Take Steps to Ease Medical Device Registration
May 14, 2013 by Stewart Eisenhart | Filed under Market: China
  The China Food and Drug Administration (CFDA) has announced steps in recent weeks to improve its medical device classification process and ease the path to market for innovative devices. Electronic validation for CFDA device classifications First, the CFDA is establishing an online system for medical device manufacturers to request regulatory validation of their product classification at the provincial or central level. Previously, manufacturers unsure of how to classify their devices under the Chinese system would have to submit classification requests in writing.
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FDA Data Shows Increase in Warning Letters to Medical Device Firms Since 2005
May 8, 2013 by Stewart Eisenhart | Filed under Market: USA
US Food and Drug Administration medical device quality system inspectors have issued warning letters to manufacturers at an increasing rate since 2005, FDA inspection records show. The steady increase in Form 483 observations and warning letter citations coincides with higher rates of FDA Quality System Regulations compliance inspections since 2008. (FDA officials conducted 1423 quality system inspections at medical device manufacturers in 2008, compared to 2121 in 2011 and 2087 in 2012.) Clearly the more quality system inspections US regulators conduct, the more noncompliance issues they observe and cite.
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Staff Shakeup Underway at Russian Medical Device Regulator

May 6, 2013 by Stewart Eisenhart | Filed under Market: Russia
  Medical device registrations in Russia remain on hold as the government reorganizes the registration division of its device regulatory agency Roszdravnadzor. According to Russian news sources, Roszdravnadzor ‘s registration office has been temporarily closed as authorities investigate allegations of bribery among senior officials. The government plans to assemble a new team of personnel for the Roszdravnadzor registration division, and also intends to review all medical device Registration Certificates previously issued by the agency.
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US FDA Updates Plans for UDI and Post-Market Surveillance System
April 25, 2013 by Stewart Eisenhart | Filed under Market: USA
The US Food and Drug Administration has published a report updating its plans for a nationwide medical device post-market surveillance system, including implementation of a Unique Device Identification (UDI) framework. The agency’s Center for Devices and Radiological Health (CDRH) plans five major steps in 2013 to establish the national post-market surveillance system:
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New IMDRF Guidance Sheds More Light on UDI for Medical Devices
April 24, 2013 by Stewart Eisenhart | Filed under Market: Worldwide
The International Medical Device Regulators Forum (IMDRF), formerly known as the Global Harmonization Task Force or GHTF, has published long-awaited draft recommendations for Unique Device Identification (UDI) systems (PDF) for medical devices.
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EU Parliament Publishes Response to Draft Regulations for Medical Devices
April 18, 2013 by Stewart Eisenhart | Filed under Market: Europe
The European Union Parliament has recently published a draft response to EU Commission proposed legislative changes for the European medical device market. 
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Recommendations for European UDI System Released
April 11, 2013 by Stewart Eisenhart | Filed under Market: Europe
European Commisioners have published recommendations for an EU-wide Unique Device Identification (UDI) system in the Official Journal of the European Union.
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South Korean Medical Device Approvals Up 7% in 2012
April 5, 2013 by Stewart Eisenhart | Filed under Market: Korea
South Korea’s Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration, has released new data showing that medical device approvals increased by nearly seven percent from 2011 to 2012. The MFDS attributes the increase to growing demands for devices among an aging South Korean population.
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