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 is 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.

2011年 8月 1日

Brasilien vereinfacht BGMP-Anforderungen für Hersteller mit INMETRO-Sicherheitszertifikat

Mit diesem Mitteilungsblattinformieren wir Sie über neue Vorschriften, die vor kurzem von der brasilianischen Regulierungsbehörde zur Gesundsheitsüberwachung (ANVISA) erlassen wurden.
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2011年 8月 1日

IOM Report: FDA 510(k) Program Too Flawed to Salvage

A long-awaited report issued July 27 by the Institute of Medicine of the National Academies (IOM) has recommended that the US Food and Drug Administration (FDA) replace its current 510(k) program for Class II medical device reviews with a new process that does not rely on substantial equivalence for clearance decisions.
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2011年 8月 1日

Le Brésil assouplit les exigences relatives aux Bonnes Pratiques de Fabrication Brésiliennes (BGMP) pour les fabricants en possession de la certification INMETRO

Par la présente, nous vous informons des nouvelles dispositions récemment adoptées par l’Agence nationale de surveillance sanitaire au Brésil (ANVISA).
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2011年 8月 2日

European Regulatory Update: RoHS Recast, CMC Decision on Labeling, New EU Commission Website

RoHS Recast The recast of the RoHS Directive (Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment) has been adopted and was published in the Official Journal of the European Union (OJEC) in July of this year. Compliance to the directive is demonstrated through CE Marking.
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2011年 8月 2日

FDA Plans Reduced Medical Device User Fees for 2012

The US Food and Drug Administration will reduce medical device user fee rates for its 2012 fiscal year, due to $9.5 million in excess appropriations from 2011. The new rates have been published as US legislators and industry lobbying groups are aggressively questioning FDA arguments for fee increases when the Medical Device User Fee and Modernization Act comes up for renewal next year.
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2011年 8月 3日

FDA Modifies List of Standards Used in Premarket Reviews

The US Food and Drug Administration has announced changes to its recognized consensus standards used in
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2011年 8月 3日

Mexican Regulators May Allow Third-Party Reviews of Medical Devices

Mexico’s medical device regulator COFEPRIS is considering utilizing third-party reviewers to speed up submissions under...
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2011年 8月 4日

JFMDA Pushing for More Flexible Accreditation System in Japan

The Japan Federation of Medical Device Associations (JFMDA) has filed a petition with the country’s Ministry of Health, Labour and Welfare as well as the Pharmaceutical and Medical Devices Agency (PMDA) arguing for more flexible accreditation requirements for foreign device manufacturers that move factories or change names due to mergers or acquisitions.
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2011年 8月 15日

FDA Draft Guidance Identifies Benefit-Risk Factors Used for Premarket Reviews

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications. In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).
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2011年 8月 15日

Health Canada Proposes Risk-Based Inspection Model

Health Canada is seeking comment from industry on a proposed risk-based inspection model for medical...
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