Information / Links
Apart from the member countries of
the EC, the routes to market can vary
widely from country to country .
In general terms the time, costs, data collation,
compliance evidence and
resources necessary to attain regulatory approvals
tend to be by-passed in business, product development
and marketing plans.
We have included indicative steps to market in
EC,
US, and
Canada. Please call for
assistance for any other country e.g. Japan and China.
- EC Directives
-
EC Guidance
- UK Guidance
- US Guidance
- Canadian Guidance
- Australian Guidance
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REGULATORY AFFAIRS NEWS |
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ISO
ISO announce survey for ISO 13485
review in preparation for revision of 13485 and
14969:2004 guidance document. Note: Must be completed by 31
August 2011.
Conduct
Survey
EC
ISO
14155:2011 Updated Standard published for Clinical
Investigations.
US
FDA
Publishes new guideline Using Human Factors & Useability
Engineering
Get
Guideline
FDA
publishes next steps in 510k process.
Get Report
FDA launches new "Basics For
Industry Website" and pledges better communication with
industry.
Access Site
FDA Provides New Process Validation
Guidance
Access Document |
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