ANVISA Strike to Delay Medical Device Reviews in Brazil

AnaMariaVR2

AnaMariaVR2

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:read:ANVISA strike to delay medical device reviews in Brazil
htt p :// www .massdevice .com/blogs/arezu-sarvestani/anvisa-strike-delay-medical-device-reviews-brazil - OBSOLETE BROKEN 404 LINK(s) UNLINKED

ANVISA Announces Continuity Measures for Medical Device Importers During Strike
Global Medical Device Consulting

Strike Has Already Affected Major Country's Ports
http :// www. stolthaven.com.br/english/storage-news/strike-has-already-affected-major-countrys-ports - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Brazilian Regulators Go On Strike
http :// www .raps. org/focus-online/news/news-article-view/article/1970/brazilian-regulators-go-on-strike/ct/b92c8962ace5ed2a86295fdc2c5a4a74fdfd74cfc01107de11812a72797c213ec0c4f02bd6625597c16396b73e834fd1095702406b6951bcb295969cfa866e59.aspx - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
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AnaMariaVR2

AnaMariaVR2

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link above is broken, here is the active one:

ANVISA strike to delay medical device reviews in Brazil
http :// www .massdevice.com/blogs/massdevice/anvisa-strike-delay-medical-device-reviews-brazil - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
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AnaMariaVR2

AnaMariaVR2

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ANVISA's strike has ended

Anvisa changes rules for expediting drugs and medical devices imports - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Most Brazil public workers to end strike on Monday

Brazil strikes headache for President Dilma Rousseff

Greve leva Anvisa a priorizar importações em portos e aeroportos de cinco estados

Strike has already affected major country's ports

Devices Flowing Again After Twin Government Strikes in Brazil End


Agency employees officially returned to work on 3 September, following a meeting of ANVISA’s executive board to relax certain requirements in order to address backlogs of medical equipment imports at Brazil’s ports, airports and border stations.

Suspension of Some Imported Product Requirements
Although ANVISA has resumed full operations, the agency’s executive board has suspended certain provisions of RDC No. 81/2008 in order to stabilize inventories of medical supplies; those inventories fell considerably during the ANVISA strike, and the board has argued that suspending precautionary measures in RDC No. 81/2008 will enable faster importation of bottlenecked devices and equipment into Brazil without compromising public safety.

Specific provisions of RDC No. 81/2008 that have been amended include the following:

*Suspension of licensing for pre-boarding health products
*Suspension of authorization of legal documentation for health products being imported (the document that authorizes ships to moor at Brazilian ports)
*Suspension of permits for customs transit

Reallocation of ANVISA Staff
Along with amendments to RDC No. 81/2008, ANVISA is positioning staff and resources in ports and border stations where backlogs of medical supply imports is most acute in order to expedite entry into and distribution of products in the country.

Bottom Line: Market Stability
What does the resolution of the ANVISA strike—as well as the easing of importation requirements—mean for medical device manufacturers already active or interested in the Brazilian market? First and foremost, the end of the strike provides a more stable and predictable regulatory environment in terms of registration of medical devices and quality system inspections. Importation challenges for foreign manufacturers brought about by the strike should also abate now that ANVISA is back to work.
 
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