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 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
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
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
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...
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
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
2010年 12月 15日

European Court Limits Member States’ Authority over Medical Device E-Commerce

The European Court has recently ruled to limit member states’ authority to restrict medical
2010年 12月 21日

EC Report: Joint Replacement Surgeries on the Rise

A new report issued by the European Commission and the Organization for Cooperation and Economic...
2010年 12月 28日

New Adverse Event Reporting Guidelines for Europe

The European Commission has issued new guidelines for how entities conducting clinical trials should report serious adverse events to appropriate national competent authorities (NCAs). The new rele
2011年 1月 5日

FDA Proposes Recordkeeping Requirements for Third-party 510(k) Reviewers

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting...