Posts Tagged ‘Medical Devices’

ISO 13485

tisdag, augusti 28th, 2012

MedTechbloggen informerar:

The European standard EN ISO 13485:2012 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’ (ISO 13485: 2003) is published. This European Standard was approved by CEN on 24 January and will be available next week.

Vad är det då som skiljer 2003 års utgåva och den nya? I den globala ISO-standarden har man inte ändrat ett enda ord! Däremot i EN-standarden har man lagt till ett reviderat europeiskt förord. Bilagorna ZA, ZB and ZC är också nya. Det svenska Läkemedelsverket hade skickat en formell protest mot 13485 och påtalat att det kunde tolkas in avvikelser mot det medicintekniska regelverket, därav reviderat förord och bilagan Z.

Ett uttalande från Jim Mackenzie: ”I would not buy this standard with urgency if at all. The body of the text has not changed. The annexes add very little value.”

Men, du gör som du vill! SIS ska ju också tjäna pengar…

GHTF

måndag, juni 11th, 2012

MedTechbloggen bjuder på lite info:

The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. Beginning in 2006, membership expands to include three Liaison Body members: Asian Harmonization Working Party (AHWP), International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC).

The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices. These documents, which are developed by five different GHTF Study Groups, provide a model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities.

Det senaste förslaget är riktlinjer/standard för att skapa enhetlighet vid inspektionsrapporter mellan myndigheter, certifieringsorgan, Notified Body etc. I dagsläget skiljer sig rapportering, bedömning och avvikelsehantering relativt stort mellan olika länder och regioner. Våra numera globala affärer kräver en ökad transparens i informationsutbytet. En viktig del vid normal regulatorisk due diligence är att kunna tolka och bedömma ex.vis inspektionsrapporter. 

Det dokument som GHTF senast presenterat har titeln  ”Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Exchange”. Här hittar du dokumentet. Där finns ex.vis system för gradering av avvikelser och blanketter. GHTF tar gärna emot synpunkter på innehållet.

Health Canada

måndag, februari 7th, 2011

MedTechbloggen har tidigare beskrivit några av de guidelines som Health Canada givit ut.

Diana Dowthwaite, Director General, Health Canada:

”I am pleased to inform you that Health Canada has finalized the guidance document entitled ”Mandatory Problem Reporting for Medical Devices (GUI-0059)”, which is now available on Health Canada’s Compliance and Enforcement website under ”What’s New”.

This guide replaces the policy aspect of the current GUI-0055 document entitled ”Mandatory and Voluntary Problem Reporting for Medical Devices”, which was published in January 2003 and contains both policy and guidance elements. It also states the requirements and responsibilities regarding medical device compliance and enforcement in Canada, in accordance with the regulatory requirements of the Food and Drug Act and Medical Devices Regulations.”

Så nu vet du!