ANVISA, Brazil’s medical device market regulator, called off a strike that began in July. The decision to strike jeopardized foreign manufacturers’ importation and commercialization efforts in Brazil, Latin America’s largest med device market. Although the decision will provide more stability for medical device companies it will take time for the agency to resume normal operations.
ANVISA employees officially returned to work on September 3rd, following a meeting of the agency’s executive board to relax certain requirements in order to address backlogs of medical equipment imports at Brazil’s ports, airports and border stations. The board also decided to suspended certain provisions of RDC No. 81/2008 in order to stabilize inventories of medical supplies. Inventories for some devices fell considerably during the strike. The decision to suspend provisions of RDC No. 81/2008 will enable faster importation of backlogged 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 the suspension of the above provisions to RDC No. 81/2008, ANVISA is re-positioning staff and resources to ports and border stations in order to address acute backlogs of medical supply imports and expedite entry into and distribution of products in the country.
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