De Europese Commissie heeft het volgende persbericht uitgegeven naar aanleiding van voorstellen voor twee nieuwe...

The Association for the Advancement of Medical Instruments (AAMI), a US-based organization advocating standards for medical devices and technology, has partnered with life sciences firm Underwriters Laboratories to develop standards for medical device interoperability .

The State Food and Drug Administration (SFDA), China’s medical device market regulator, will begin requiring all outside labeling and packaging of devices to be provided in Chinese starting in April 2013. According to the SFDA and the Regulatory Affairs Professional Society (RAPS), a recent SFDA notice sent to the agency’s provincial and municipal branches in China mandates that all outside labeling and packaging of medical devices include a version in Chinese. Failure to provide labeling and packaging text in Chinese will prevent manufacturers and sponsors from marketing their devices in China.

The US Food and Drug Administration has published guidance outlining its plans for requiring medical device manufacturers to submit registration materials electronically via the agency’s eCopy Program. The eCopy Program is currently voluntary, but will become mandatory upon finalization of the proposed guidance as required by the Food and Drug Administration Safety and Innovation Act signed into law earlier in 2012. Once mandatory, the program will require manufacturers to submit eCopies along with standard application documents in order for the FDA to process and review them. Applications that do not include eCopies of their submissions will be put on hold until applicants provide eCopies.

The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs were released by the EU Commission with significant fanfare on 26 September 2012. The weaknesses cited in the Executive Summary/Impact Assessment of the EU regulatory system, were not a shock. The MDEG report (2002) had identified these as areas of concern. In reviewing the changes it became apparent to us there are several themes in the proposed legislation: Oversight of Notified Bodies, Post-market safety, Transparency and traceability, access to external expertise and management of the regulatory system. The impact of the PIP scandal was apparent.

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the average total time for 510(k) decisions to 124 days from 150 days for fiscal year 2012.

A recent investigation by British journalists has brought to light questionable practices by certain European Notified Bodies, prompting greater urgency for medical device regulatory framework revisions proposed in September 2012.

Argentinean medical device market regulator ANMAT has launched a TechnoVigilance Program for Medical Devices (PDF...

The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force, has proposed draft criteria for use by medical device market regulators to recognize qualified auditing organizations. The draft proposal targets auditing processes conducted as part of conformity assessments as well as of post-market surveillance procedures; IMDRF members aim to establish a common list of criteria regulators can use to recognize or designate entities performing auditing services that cover medical device manufacturers. If adopted, the criteria could drive greater uniformity and efficiency in medical device quality system audits across global medical device markets.

The Russian Ministry of Health has already approved new orders regarding medical device classification, importation and adverse event handling. Also under consideration are medical device vigilance processes, conformity assessments as well as quality and safety issues. All orders under consideration must be approved before authorities begin implementing actual regulations.