GMP News - Medical Devices

13.08.13

European Commission publishes Recommendations for the Labelling of Medical Devices

There are no specific provisions regarding the traceability of medical devices in the European regulatory framework for medical devices. That’s why the EU Commission has now published "Recommendations on a common framework for a system of unique product marking for medical devices". Read more.

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13.08.13

What's new from the FDA regarding Medical Devices?

In hardly any other area the FDA ‘s Center for devices and radiological health publishes so many guidelines as in the area of medical devices. Find out what has been achieved in the last few months.

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09.04.13

FDA publishes Draft on Medical Devices Recalls Guideline

The FDA has published an independent industry guideline on product recalls, biological and medical devices. The guideline describes deficiencies which refer to regulations like for example the GMPs. Sometimes, recalls are made to serve product enhancement. In order to clearly distinguish product recalls from product enhancements, the FDA published at the end of February a draft guideline. Read more here.

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09.04.13

GMP for Medical Devices - ANVISA's Inspection Guide

The Brazilian monitoring authority ANVISA has integrated an inspection check list to the GMP guideline for medical devices. As these GMP requirements are very similar to the US American ones (21 CFR 820, Quality System Regulations, QSR), this inspection check list may also be useful for companies who want to export in the USA. Read more here.

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09.04.13

FDA's Strategies on the Regulation of Medical Products: How do they look like?

FDA's Center for Devices and Radiological Health (CDRH) published its strategic objectives regarding medical devices for 2013 in a document entitled "2013 Strategic Priorities". The document is composed of 12 pages which ... read more.

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09.04.13

How are FDA GMP Guidelines on the Regulation of Medical Devices made?

Have you also always wondered how the FDA gets its guidelines? As concerns GMP documents on the regulation of medical devices the "Device Good Manufacturing Practice Advisory Committee" (DGMPAC) plays an important role. It is the ... read more.

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14.02.13

FDA publishes List of planned Guidances for Medical Devices

At the end of 2012 the Center for Devices and Radiological Health (CDRH) published a list with the Guidances planned for the fiscal year 2013 (1 October 2012 to 30 September 2013). Read more here.

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14.02.13

Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan

Japan is an interesting market, also for medical devices. There exists a translation of the relevant Japanese regulation in the English language as concerns the regulatory requirements on the quality assurance of medical devices. The Japanese Ministry of Health, Labour and Welfare issued a Ministerial Ordinance under the number 136 in 2004 which also is available in English. Read more.

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14.02.13

China-Europe: Information on Standards and Market Requirements

The Europe-China Standards Information Platform provides bi-lingual information to Chinese and European businesses on everything from technical regulations to market access requirements. Read more.

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29.01.13

FDA publishes three Guidances to facilitate Assessment/Submission of Medical Devices

On 31 December 2012, the FDA published three new Guidances in order to facilitate the submission process for medical devices in the USA. Two guidances concern... Read more here.

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29.01.13

FDA publishes Draft Guidance on Design of Medical Devices

CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012. The intention of the guidance... read more here.

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29.01.13

GHTF ceases to work

The Globalisation Harmonisation Task Force (GHTF) ceased to work by the end of 2012. Founded in 1992 it was sort of ... Read more.

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30.10.12

Modification of ISO 13485 - new Annexes ZA, ZB and ZC

In order to adjust to the current EU-Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices, EN ISO 13485 will be modified. Many manufacturers of medical devices are certified according to EN ISO 13485 as basis for their management system for the development and production of medical devices. Read on here.

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30.10.12

QP for Manufacturers of Medical Devices - New EU Requirement?

Article 13 of the proposal for a regulation concerning the new regulatory framework for medical devices introduces a new role for manufacturers of medical devices: A person responsible for regulatory compliance. This function, referred to as "qualified person", involves certain requirements as well as responsibilities. Find out more.

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05.09.12

FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)

In July 2012, the FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical devices (Unique Device Identification System, UDI system). The Congress had already enacted a law in 2007. A draft is now available.

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