The Center for Devices and Radiological Health (CDRH) within the US Food and Drug Administration has published an updated list of recognized standards used in premarket reviews of medical device submissions. This list is generally updated every 3-6 months by FDA. You can download the most recent list published in the Federal Register.
Regulatory Affairs | Chris Schorre, Emergo Group March 19, 2009 | 
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Effective April 1, 2009 manufacturers of electrical medical devices and manufacturers of electrical components that are to be sold into the Province of Ontario are required to register with the Ontario Electrical Safety Authority. Companies will have from April 1 to August 30, 2009 to comply with this new registration requirement. You can read more about Ontario’s electrical safety requirements on the Electrical Safety Authority website.
Regulatory Affairs | Chris Schorre, Emergo Group March 13, 2009 | Comments (0)
A lot of people know that the US Department of Commerce publishes short research reports on the medical device industry in specific countries, but it’s worth repeating in case you have not visited in some time. You can read regulatory process overviews on 20+ countries at the DOC website. If you want to read the actual regulations for a specific countries, we have many of them posted in our Learning Library on our website.
In case you missed our newsletter on the topic, Evangeline Loh, our VP of Regulatory Affairs, provided some information on new European clinical data guidance documents released late last year. If you manufacture or sell stents, you’ll definitely want to read it but the information is useful to all medical device manufacturers.
Tags: MEDDEV
Regulatory Affairs | Chris Schorre, Emergo Group March 3, 2009 | Comments (0)