2012年 9月 7日
ANVISA, Brazil’s medical device market regulator, has ended a months-long strike that had complicated foreign manufacturers’ importation and commercialization efforts in the country. Resumption of normal regulatory procedures will provide more stability for medical device companies participating in Latin America’s largest medical device market.
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.
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:
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.
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.