Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

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.

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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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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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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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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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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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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DG SANCO, NBOG Guidance & Registration Italy Medical Devices

BfArM has a new PDF form for vigilance which fulfils the new German Requirements for incident reporting which became mandatory on March 21, 2010. (To provide some cursory background information, Germany, when they transposed Directive 2007/47/EC, included a new requirement on vigilance which mirrors MEDDEV 2.12.1, Revision 6.)

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Important regulatory changes in Australia

IVDs will now be regulated by the TGA effective 1 July 2010. Though 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 ...

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FDA issues report on proposed objectives for CDRH's 510(k) program

A newly released FDA report has been made available for public comment until October 4, 2010.

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Proposed Changes to Regulatory Approval Process in Mexico

On August 17, 2010, Mexico's President Felipe Calderon announced changes that will affect registration of medical devices in Mexico.

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