ANVISA Announces Continuity Measures for Medical Device Importers During Strike
Update 08/27/2012: The Brazilian Supreme Court has recently ordered ANVISA to operate at 70% capacity despite the agency's ongoing strike in order to address medical supply issues affecting healthcare providers in the country. According to Emergo Group's Brasilia office as well as Brazilian shipping service provider Fiorde International, various hospitals in Brazil are reporting shortages of blood reagents, medications and other hospital materials that are reportedly stalled at the border and cannot clear Brazilian customs. Barring a breakthrough in ongoing negotiations, observers expect effects of the ANVISA strike to last through November.
(Linked information above is available in Portuguese only; please use Google Translate.)
Emergo Group will provide updates on the ANVISA strike situation and its impact on the Brazilian medical device sector as we get them.
Brazilian medical device market regulator ANVISA has published a provision to support continued importation of products under its jurisdiction in the midst of an ongoing strike.
The continuity measures, established under RDC 40, allow for approval of import licenses for medical devices and other ANVISA-regulated products in cases where sufficient storage capacity is lacking at Brazilian ports and airports.
According to the provisions, importers may store their devices at locations of their choosing; devices qualifying for this allowance may only be sold after release by ANVISA. Importers that obtain such releases become faithful custodians of their devices, and must sign a Statement of Responsibility (ANVISA has posted a model template of the Statement of Responsibility on its website).
These provisions will close following resolution of the ANVISA strike. The regulator will carry out “essential” services—distribution of medicines, food and medical devices, for example—as the strike continues.
Emergo Group will provide additional details on the ANVISA strike as well as its impact on medical device registrations in Brazil as we get them.