Enzytec has extensive experience in the registration of products for In Vitro Diagnostics, Medical Equipment, Health Materials, among others, of classes 1, 2, 3 and 4.
So that your product is approved and can be marketed, we carry out the classification, risk classification, document review and registration, in accordance with ANVISA (National Health Surveillance Agency), MAPA (Ministry of Agriculture, Livestock and Supply) and the legislation in force. We currently register products for human and veterinary health.
For international suppliers that do not have a head office in Brazil, we provide the hosting service for the registration of medical devices and in vitro diagnostics. With it, it is possible to import the product, avoid the costs of opening and legalizing a company and still have multiple distributors without losing the rights to the registration.
We provide support in the process of obtaining the international GMP (Good Manufacturing Practices), an essential requirement for the registration of imported risk class III and IV products in Brazil.
We provide consultancy in all stages of opening and legalizing distributors and factories of health products in GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices). The consultancy includes: Architectural Design, Environmental Licensing, Inspection by the Fire Department, Regularization of Technical Responsibility, implementation of the Quality Management System, among others, until obtaining the AFE and/or CBPFeC and CBPAD.
Through our qualified auditors, we carry out audits in Factories and Distributors of health products, in accordance with the requirements of GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) of ANVISA, ISO 9001:2015 and ISO 13485:2016.
We translate and adapt Manuals, Instructions for Use and other documents for health products and in vitro diagnostics, in accordance with current legislation, in any language. Our translations are reviewed by qualified technical personnel in the areas of Pharmacy, Biomedicine, Engineering, among others, making the translation suitable for the technical application of the products.
In our own laboratory certified RDC 665/2022 (former RDC 16/2013), we carry out complete or partial validation of your products, for performance verification purposes and according to RDC 36/2015 for the purpose of registration with ANVISA. We also perform validation of veterinary products.
The questions “How long does it take?” and “What is the investment?” always appear when investments in healthcare are considered. For this, Enzytec developed the "Regulatory Planning" service, which in a few meetings and consulting hours, we prepare a project with all the regulatory steps to make your new business viable, containing financial spreadsheets with investments, expenses and human resources calculated for two first years of operation. This “Regulatory Planning”, when delivered, represents a great differential in decision-making and business plan elaboration.