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.
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REGULATORY AFFAIRS NEWS |
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EC
05.09.2007 New
Medical Device Directive Published
amending
Council Directive 90/385/EEC on the approximation of the laws of
the Member States relating to active implantable medical
devices, Council Directive 93/42/EEC concerning medical devices
and Directive 98/8/EC concerning the placing of biocidal
products on the market
Click here to see
US
Pilot Program to Evaluate the Proposed Globally
Harmonized Alternative for Premarket Procedures
See Guidelines For Reviewers (PDF)
Australia
Fact Sheet on
Fundamental differences between Australia and EC Regulations
Drafts published for comment.
See Classification (PDF)
See
Essential Principles (PDF)
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