According to Enrico de Vettori of Deloitte Brazil, “The Brazilian health care market is expensive, large, and in need of improvement. Estimated health care spending in 2013 totaled $208 billion and comprised an estimated 9.1 percent GDP. Three-quarters of the country’s 202 million people depend on free care from Brazil’s Unified Health System (SUS), the largest public health system in the world. The remaining 25 percent of the population is enrolled in private health plans. Care provided under the SUS is split between public and private providers: most in-patient services are privately owned and run, whereas most outpatient care is carried out by public facilities.”
Recently, in response to the devastating Zika outbreak in Brazil, the Brazilian Health Surveillance Agency Anvisa joined the task force Zika Zero set up by the Federal Government for the National Day of Mobilization. On Saturday Feb 13, 2016, they visited 2.8 million homes in 428 municipalities across the country. The aim was to mobilize the population for the prevention and combating of the Aedes mosquito specie, and identify its breeding sites.
Anvisa (Agência Nacional de Vigilância Sanitária) was created in 1999 to protect and promote public health and to intervene in the risks caused by the production and use of products regulated by health surveillance. Their regulatory requirements impose the need for products sold in Brazil, to be provided in the Brazilian Portuguese language.
To get your Pharmaceutical or Medical Device products qualified for sale and distribution in Brazil, there are required steps to be completed according to Anvisa. In March 2013, they released Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices. These technical regulations describe in detail the General Quality System Requirements; Quality Documents and Records; Design Control and Device Master Records; Process and Production Controls; Handling, Storage, Distribution and Traceability; Correction and Preventive Actions; Installation and Servicing; and, Statistical Techniques.
Also, Anvisa imposes protocols for the import of new drugs which require healthcare translation into Portuguese:
- Good Manufacturing Practices of importing country or inspection by Anvisa
- Label, Package Insert must be in Brazilian Portuguese language. Certain documentation allowed in Portuguese, English or Spanish language
- Official documents like certificates provided by the importing country, must be translated by a legal translation service.
According to Emergo, companies that are looking to export Medical Devices to Brazil will have to follow Anvisa’s regulatory process:
- Classify the Medical Device. The importer should first determine the classification of its medical device. Lower risk devices use a simplified application and takes less time to review.
- Appoint a Brazil Registration Holder (BRH) and provide Letter of Authorization to the BRH, who will submit a registration application to Anvisa.
- Get INMETRO Certification for devices that require them from an accredited certification body.
- Comply with BGMP. Class III and IV manufacturers must not only comply, but also be audited for BGMP compliance by Anvisa.
- Prepare Technical Dossier according to RDC 40/2015 describing elements of the product, indicating its characteristics and mode of use, contents, special care, potential risks, manufacturing process and additional information, in case of inspection by Anvisa.
- Obtain Certificate of Free Sale where needed.
- Translate and Submit all Documents into Brazilian Portuguese for all device classes, including the technical dossier.
- Anvisa Reviews and upon approval, will publish a registration number in the Diário Oficial da União(DOU).
- Appoint Qualified Importer/Distributor to bring your device into Brazil.
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