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.

2010年 12月 2日

Australian TGA Updates IVD Regulations

The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010. The changes will be implemented on 1 July 2010, and serve to amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes to TGA legislation pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs); the likely implications of which are described below.
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2010年 12月 15日

EU Unveils New Medical Device Clinical Investigation Guidelines

New medical device guidelines, MEDDEV 2.7.4 , addressing clinical investigations have been issued in the Eu
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2010年 12月 15日

40-year EU Patent Impasse at an End?

The European Patent Office (EPO), the European Commission body theoretically responsible for evaluation of patent applications, appears closer than at any point in the last 40 years to achieving a mor
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2010年 12月 15日

MEDDEV 2.7/4 and EU Court Ruling on E-Commerce

MEDDEV 2.7/4 on clinical investigations is available on the European Commission website, and also in...
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2010年 12月 13日

HC Makes Some Allowances for Paperless Medical Device Labeling

Health Canada has issued a new interpretation of Canada’s
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2010年 12月 10日

Mexican Market Entry Just Got Easier

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms. The Mexican Health Author
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2010年 12月 8日

Regulatory Reforms in Mexico’s COFEPRIS

On October 26, 2010 COFEPRIS (the Federal Commission for Protection against Sanitary Risks, of the Mexican Health Authority) officially announced the equivalence agreement to be applied to medical
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2010年 12月 8日

HC Sets Compliance Deadlines for Revised Software Requirements

Software manufacturers whose products fall under Health Canada’s medical device classification system have until February or September 2011 to comply with new requirements set forth by the regulator.
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2010年 12月 2日

US FDA 510(k) Regulatory Process Update

Important changes are affecting the US FDA’s 510(k) process; namely the Transparency Initiative and the issuance of the 21 Draft Proposals which are now open for Public Comment.
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2010年 12月 2日

New OJEC Standards & MEDDEV on Medical Device Classification

On 7 July 2010, the newly issued list of standards (considered European norm harmonized to the directives) was published in the Official Journal of European Communities (OJEC). To this end, each directive has a corresponding list of applicable standards. The list appropriate to the directive can be referenced here: MDD , IVDD , and AIMDD .
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