Biotechnology and Biopharmaceutical

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International Medical Device Registration
Editor: Maria Donawa
Publisher: CRC / Interpharm Press
Copyright: 1996
Price: $249.00

This binder is a compilation of the regulations affecting medical device and medical equipment registration worldwide. Edited by Maria Donawa, an ex-FDA staffer based in Italy, this handbook brings together the skills and expertise of 20 regulatory experts from around the world.

Countries include: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Nigeria, Norway, South Africa, Spain, Switzerland, United Kingdom, United States of America and Venezuela.

Within each country, the text includes (as applicable):
-- The application process
-- Forms required
-- Fees and charges
-- Device classifications
-- CE marking
-- Labeling
-- Regulatory inspections
-- Clinical investigation requirements
-- Post marketing requirements
-- GMP recovery regulations
-- Cost recovery regulations
-- ISO 9000/CEN/other standards
-- Agency addresses and contacts
-- Adverse event reporting requirements

The book is designed to be a time-saving tool for anyone involved in the worldwide sourcing, manufacturing or registration considerations within the medical device industry. Active and inactive implantable devices, sterile disposable devices, dressings, and diagnostic materials are all covered.

To order, or for more information, contact:
CRC Press LLC
2000 NW Corporate Blvd
Boca Raton, FL 34431 USA
Telephone: +1 800-272-7737 or +1 561-994-0555
Facsimile: +1 800-374-3401 or +1 561-989-9732
   
 
Bookshelf