Brazil’s National Health Surveillance Agency (ANVISA) published a new regulation to reduce bureaucracy and eliminate unnecessary demands that raised the cost of imported healthcare products.

The resolution RDC 208/2018 eliminated several requirements established by the previous norm, which obliged companies to submit documents only available after the shipments arrived in the country, increasing warehousing time that translated into higher costs and smaller competitiveness of imported goods in the Brazilian market.

With this new regulation, ANVISA revoked all legal apparatus that determined sanitary analysis should be made only in the Brazilian customs and that required signature authentication. RDC 208/2018 also removed: the exigency of declaring lot number, the exigency of presenting boarding authorization, and other documents already listed in the electronic petition formed, now integrated into the Paperless Port Program.

Following the new procedure, ANVISA considers the import process for healthcare products will be considerably simplified, permitting the agency to focus their initiatives into products that present a greater threat to public health.

RDC 208/2018 is already in force in the whole country and has already reduced clearance deadlines for healthcare importers.

Source: National Health Surveillance Agency (ANVISA)