International manufacturers who wish to market their products in Brazil need to have a registered and fully regulated company in order to be able to register their products. This company must have a legal representative and a legally qualified technician in charge, who will be responsible for the medical devices in Brazil.
Oyster Consulting independently offers this entire structure for the international manufacturer to register their products in Brazil, at a low cost. In a faster and more dynamic manner.
Advantages of registering products through Oyster Consulting:
1. Cost-benefit (1/8 of the costs of maintaining a company in Brazil.)
2. The company is focused on Regulatory Affairs, while distributors focus on sales. Eliminating the risks of missing the deadlines for renewals or other relevant respects.
3. Freedom of choice and appointment of several distributors across the country. Not sticking to only a single distributor. When opting for registration through the distributor, the holder of the registry will be the distributor (and not be the manufacturer abroad) for a period of five years.
- Direct import from the manufacturer by the distributor, since Oyster sends the necessary documents for the distributor to import the products. Reducing both costs and time.
- In this option, the manufacturer is the owner of the registry, determining who will be its distributors.
- Independence in the relationship between manufacturer and Oyster. There is no conflict of interest, since Oyster does not sell products. It only meets the regulatory requirements and provides import services.
- Oyster will annually qualify its distributors. The first qualification takes place at the beginning, when the manufacturer appoints the distributor. This provides the assurance that the products are stored and distributed by a qualified distributor according to the relevant Brazilian legislation.
- Oyster will be its legal representative and technician in charge before the regulatory entities.
9. Insured agreement between the parties, guaranteeing the right to the good use of product registrations, as well as any other manufacturer’s interests.