Each month (except December) Advena Ltd. compiles two reports which
summarize the regulatory activities of authorities in the European Union and United
States (including Canada) and lists relevant updates to medical device related
standards. In every issue you'll get a summary of the latest news, regulatory
updates, meetings, warning letters and notices, as well as links you can click for
more information. In addition we will include pertinent information on other counties
world-wide, when and if this is available.
Up to now these reports have only been available to our contracted EU Authorised
Representative and US Agent clients. However, Advena Ltd. is now extending annual
subscription offers to interested parties.
If you are interested in purchasing an annual subscription you may do so by visiting
our Payments page . The cost for each annual subscription is US$300 dollars, or you
may purchase both the EU and US subscriptions for a discounted rate of US$550 per
year.
By subscribing to the Advena Ltd. Monthly Regulatory Reports today you could save
hours of research time and stay ahead of your competition.
RESOURCES
NEWSLETTERS
European Union
•
EAAR - European Association for Authorised Representatives
•
ISO - International Organization for Standardization
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EUROPA - European Commission
•
BSI - British Standards Institute
•
CEN - European Committee for Standardisation
United States
•
FDA Center for Devices and Radiological Health (CDRH)
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21 CFR Part 820 FDA Medical Device Quality System Regulations
•
FDA - Who must register, list and pay the fee?
•
FDA Medical Device Registration and Listing Database
Australia
•
TGA - Therapeutic Goods Administration
Canada
•
MDALL - Health Canada