All manufacturers outside of Brazil will need to work with a third-party organization to obtain registration and renewals in Brazil
MediPoint: Bone Grafts and Substitutes - South American Analysis and Market Forecasts - a new market research report on companiesandmarkets.com
PR-Inside.com: 2014-04-30 05:53:01
Although autograft is still perceived as the gold-standard material in bone grafting, the wide array of alternatives available in the market has resulted in a gradual shift towards increased adoption of bone grafts and substitutes (BGS), especially in the US and European markets. In contrast to the general picture in developed countries, autograft bone still represents the most popular option during bone grafting in the Asia-Pacific (APAC) region and South America.
All manufacturers outside of Brazil will need to work with a third-party organization to obtain registration and renewals. Requirements include sales certifications, Good Manufacturing Process (GMP) documents, and letters authorizing a Brazilian firm to conduct distribution, clinical trials and details of the device. Due to the extensive paperwork ANVISA requires from foreign manufacturers, market entry is cumbersome for medical devices to enter Brazil, even though there is a huge market potential for orthopedic devices in this country.
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