Wednesday 20 August 2014

brazilanvisa

Brazilian Regulators Go On Strike – ANVISA

In mid-July Brazilian government officials, including those at the regulatory agency ANVISA, walked-out on strike, leaving the agency critically under-staffed. As of August 1, the strike has lasted 40 days, with no sign of resolution yet (learn more here; link in Portuguese).

Anivsa said in a statement that the Brazilian Supreme Court has ordered it to ensure at least 30% of its work force remains on the job during a strike of the regulatory agency’s workers. Anvisa has reportedly assured industry that the agency will continue to review and approve marketing authorization applications and maintain essential services during the strike.

As a matter of law, the worker’s union must ensure that a sufficient number of members continue to work in order to “avoid irreparable harm, irreversible deterioration of goods, machinery and equipment, as well as the maintenance of essential activities”

Union leaders made it clear that plans to intensify the strike will take effect unless the federal government presents a proposal to address workers’ demands for salary increases. The strikers’ intensification plans will affect all customs and importation activities in Brazil, and possibly to a higher degree of paralysis among governmental agencies. The impact on ANVISA is unkown.

To date the strike has resulted in delays for manufacturers and importers required to obtain regulatory approval to sell their medical devices in Brazil. ANVISA has put contingency measures in place in an effort to keep imports flowing. Under RDC 40, ANVISA is authorized to approve import licenses for medical devices and other products under its jurisdiction in the event of inadequate storage capacity at Brazilian ports or airports.

The RDC 40 provisions allow importers to store their devices at locations of their choosing in Brazil until registration delays are resolved. This will allow importers to store their devices in distributor warehouses instead of having them remain at the port. Importers with medical devices for long-shelf life may take advantage of this provision. Other importers should begin talking with distributors about the delays.

Devices that fall under RDC 40 cannot be sold until official release from ANVISA. A qualifying importer first becomes a “faithful custodian” of its device and must sign a Statement of Responsibility. ANVISA has posted an example of a model Statement of Responsibility on its website. Afterwards an importer receives a customs release for its device and may begin marketing the product in Brazil upon resolution of the strike.

More updates will be posted here when available.

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