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Brazilian Government Wants Warranties to Accompany Medical Devices

Brazilian lawmakers are considering adding another layer of red tape to the country’s already burdensome business development process.

In recent years, prospective entrepreneurs have had to hack their way through an Amazonian thicket of bureaucracy to gain a foothold in South America’s largest economy. Vinicius van der Put, for example, spent six months and countless hours at eight different government agencies to obtain a temporary business license for his telecommunications startup. And Moinho Pacífico Indústria e Comércio President Lawrence Pih—owner of Brazil’s largest flour mill—located his plant at a port to compensate for customs delays. Moreover, a study by Brazil's small business association found that 70 percent of entrepreneurs who try to legally open a business in the country never complete the extensive documentation process (roughly 100 different forms are required).

That credentialing process could become even more extensive if the Brazilian Senate approves legislation requiring manufacturers of orthotic, prosthetic and implantable medical devices to provide a warranty certificate for their products. The regulation—already approved by the Committee on Constitution, Justice and Citizenship—requires the warranty certificate be issued by the importer or domestic manufacturer.

According to the proposal, the certificate must accompany the product and be available for its intended user(s). It should contain manufacturer’s data, material specifications, patient name, medical record number, date of surgery and surgeon’s signature. A copy of the document specifying the implant materials must be given to the patient, and hospitals are required to maintain a copy of the warranty certificate as well.

The Commission on Social Security and Family, and Economic Development Commission also support the legislation.

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