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.
Medical (Related), Food, Cosmetics, Sanitizing and Tobacco products are subject to approval by ANVISA prior to marketing. Part of a successful approval is the correct classification of products. Oyster Consulting has highly skilled personnel to classify and assemble the technical dossier for registering products.
Assembling of technical dossier for registering the following products:
– Health Products (Related); Foods; Cosmetics; Sanitizing; Tobacco at Anvisa
– Veterinary Products and Food, Beverages and Agricultural Products, at MAPA (Ministry of Agriculture, Livestock and Food Supply)
Technical Regularization Certificate (Ministry of Health and Agriculture)
Other necessary registrations.
Oyster Consulting performs all the regularizations for your company, since the diagnosis of the physical area; regularization at competent bodies in municipal, state and federal scopes; development of Good Manufacturing Practices Manual and Standard Operating Procedures until the training of the entire team in the Quality Management System.
Good Manufacturing Practice (GMP)
Health product companies and manufacturers wishing to market their products in Brazil must comply with the Brazilian GMP/ANVISA regulation standards. Since 2009, Anvisa made GMP/Anvisa mandatory to all risk class III and IV health product manufacturers.
Anvisa audits national and international health product manufacturers, including domestic importers. After the successful audit, Anvisa issues a GMP certificate, thus allowing the filing of product registration at Anvisa. The period to obtain such certificate depends on the demand of the Brazilian National Health Surveillance Agency itself
Manufacturers may also obtain the GMP certificate through the inspection report issued from an inspection performed by AO (Auditing Organizations) that are part of the MDSAP pilot project.
– The manufacturers should contract an AO to audit it within the MDSAP program. By hiring the organization for the MDSAP audit on the company intending to export products to Brazil, the audit should necessarily include the Brazilian regulatory requirements.
The MDSAP Pilot program has the following International Partners:
– ANVISA, the Brazilian National Health Surveillance Agency;
– the Australian Therapeutic Goods Administration (TGA);
– Health Canada, Canada;
– U.S. Food and Drug Administration, United States;
– Observers: Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Oyster Consulting implements the Quality Management System/GMP for the following certifications: RDC-16/Anvisa; ISO 13485/2016; ISO 14371; CE marking; FDA and others.
The pilot project aims to enable health product manufacturers to hire an Auditing Organization, authorized under the pilot project, to perform a single audit encompassing the relevant requirements of the participating Regulatory Authorities;