Because of the number and complexity of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has published many new guidelines. This makes it difficult to keep track of the current situation. In the following, we have compiled a selection of new FDA documents with regard to aspects of quality assurance and marketing authorisation ... Read more here.
What about the Successor Organisation (IMDRF) of the GHTF?
In one of our News we reported about the end of the Global Harmonisation Task Force (GHTF) and presented the International Medical Device Regulators Forum (IMDRF) as successor organisation. For a start, the IMDRF has taken over the "old" GHTF guidelines and plans to develop them further successively where necessary. First efforts have now been made. Read more here ...
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.
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.
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.
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.
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.
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.