Medical Device Watch

Introductory paragraph here

GHTF publish additional guidance on auditing of QMS

Posted on November 2, 2010 by Dina Morton

The Global Harmonization Task Force (GHTF) have published additional guidance as follows:

  •  SG4/N30 2010 Guidelines for Regulatory Auditing of QMS of Medical Device Manufacturers – Part 2 Regulatory Auditing Strategy
  • SG4/83 2010 Guidelines for Regulatory Auditing of QMS of Medical Device Manufacturers – Part 4 Multiple Site Audits
  • SG4/84 2010 Guidelines for Regulatory Auditing of QMS of Medical Device Manufacturers – Part 5 Audits of Manufacturer Control of Suppliers
  • SG1-N65 2010 Registration of Manufacturers and other parties and of medical devices

Further information can be found at http://www.ghtf.org/sg4/sg4-final.html

Posted in Medical Device Consultancy, Standards & Guidance Update, UK & EU Quality & Regulatory | 2 Comments

FDA formally recognises AAMI’s Human Factors standards

Posted on October 15, 2010 by Dina Morton

FDA has now formally recognised the following AAMI human factors standards:

  • AAMI / ANSI HE74-2001, Human factors design process for medical devices
  • AAMI / ANSI HE75:2009, Human factors engineering – Design of medical devices.

For further information please see the link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm

Posted in Medical Device Consultancy, US Quality & Regulatory | Tagged , , | 1 Comment

Final phase of Sinapore’s regulatory framework entered

Posted on September 24, 2010 by Dina Morton

Singapore’s Health Sciences Authority regulatory framework is now in the final phase of it’s implementation. This requires all types of medical devices to be registered by 1 Jan 2012. Unless exempt from registration, all devices that are imported and supplied must fulfill one of the following:

  • Listed on the Singapore Medical Device Register (SMDR);
  • Listed on the Transition List; OR
  • Authorised via one of the Authorised Routes.

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    Further information can be found at http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/regulatory_framework.html

    Posted in ROW Quality & Regulatory | Tagged , | Leave a comment

    Formal voting on final version of ISO 14155 Clinical investigation of medical devices for human subjects

    Posted on September 15, 2010 by Dina Morton

    ISO committee has published the FDIS for ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. The final version had been submitted at the end of March by the TC 194WG 4 working group. This is now out for formal voting with a deadline of 9th November 2010. ISO 14155:2010 will replace ISO 14155-1:2003 and ISO 14155-2:2003.  Further details and to order a copy can be found at http://www.iso.org/iso/catalogue_detail.htm?csnumber=45557

    Posted in Medical Device Consultancy, Standards & Guidance Update | Tagged , , | Leave a comment

    FDA reclassify certain Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters

    Posted on September 10, 2010 by Peter Rose

    21 CFR part 870 (CARDIOVASCULAR DEVICES) has been amended to reclassify PTCA catheters as described in 21 CFR 870.5100 (a). as a class II (special controls). They were previously a class III (pre market approval).

    Full details can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm225145.htm

    Posted in Medical Device Consultancy, US Quality & Regulatory | Tagged , , , , | Leave a comment

    CDRH/FDA Public Webinar Tuesday 31st August

    Posted on August 25, 2010 by Dina Morton

    The Center for Devices and Radiological Health/US Food and Drug Administration will be holding a free webinar on the ‘FDA Discussion on the Draft 510(k)’ and ‘Use of Science in Regulatory Decision Making’ Reports. Preliminary Internal Evaluation reports have been issued and can be found at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm. The webinar is an opportunity for the CDRH/FDA to discuss the details of the reports and respond to the medical device community questions and concerns. The webinar will begin at 1pm (EDT) – that’s 6pm BST.

    Posted in Medical Device Consultancy, US Quality & Regulatory | Tagged , , | Leave a comment

    New guidelines on IVDs from the TGA

    Posted on August 25, 2010 by Dina Morton

    As part of the Australian Regulatory Guidelines for Medical Devices (ARGMD) the TGA are developing a number of guidelines specific for IVD’s. The first of these have been published as follows;

    • Classification of IVD medical devices
    • Fees and charges for IVD medical devices
    • Including IVD medical devices in the ARTG

     Further information can be found at the following link: http://www.tga.gov.au/ivd/ivd-guidance.htm

    Posted in Medical Device Consultancy, ROW Quality & Regulatory | Tagged , | Leave a comment

    PVC with permanently bonded phthalate around the corner?

    Posted on August 25, 2010 by Dina Morton

    A study in the ACS’ Macromolecules, a bi-weekly journal, reveals a recent study by scientists in which they have found a new way of potentially preventing harmful plasticizers from migrating out of PVC. The study describes a way in which the phthalate can be permanently bonded, or chemically attached to the internal structure of PVC. This could have potential benefits for medical device manufacturers. Further details can be found at http://www.medicalnewstoday.com/articles/197594.php

    Posted in Medical Device Consultancy, Uncategorized | Leave a comment

    Training programme announced

    Posted on August 18, 2010 by Dina Morton

    We are pleased to announce the launch of our medical device training programme. There are a selection of courses that are available as open public courses and in-hourse courses. Open courses start from September and there are ‘early bird’ offers available on all courses. In-house courses are available now. We will expanding the open courses over the next 12 months to introduce topical and essential courses for those involved in the medical device industry. To see the list of available open courses go to http://www.highedge.co.uk/public-courses.php or to http://www.highedge.co.uk/in-house-courses.php for in-house courses.

    Posted in Medical Device Consultancy, Training | Tagged | Leave a comment

    New guidance for medical devices in India

    Posted on August 18, 2010 by Dina Morton

    India’s Central Drugs Standard Control Organization has recently published the following guidance documents

    1. Guidance document on common submission format for registration of medical devices in India.
    2. Requirements for conducting clinical trial(s) of medical devices in India
    3. Guidance document on the application for grant of License in Form 28 for manufacture of Medical Devices in India under the CLAA scheme.

     These can be found at the following link:   http://cdsco.nic.in/

    Posted in Medical Device Consultancy, ROW Quality & Regulatory | Tagged , | Leave a comment
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