Mandala International, the key to your success in Brazil!
WHAT WE DO
Mandala International aims at acting as a commercial and third partner on trust matters.
Mandala will take care of the records of your products, will provide the advisory service for applicable additional compliance certifications (Inmetro, Anatel, laboratory tests for drugs), will be its regulatory legal representative in the country, it will guarantee the maintenance of your records and post-registration regulatory actions in compliance with applicable law (health surveillance, technical and administrative modifications, renewal,…).
In addition to being your partner in the certification of your products, Mandala will support you in the legalization processes of your company with the operating authorizations (AFI, License, Sanitary License), the National and International Manufacturing Audits (BPF), as in the preparation of the quality management process.
Thus, Mandala International will take care of regulatory and administrative requirements, while you remain independent and autonomous, and can choose your partners for marketing your products in the country.
REGISTRATIONS IN BRAZIL
It is necessary that products focused on the human health industry be registered or duly noted by Anvisa before going through any type of commercialization.
Mandala is fully aware of the interpretation of the legislation, practices and requirements of Brazilian bodies to accompany you in the legalization of the following:
- Medical devices;
- Sanitizing products;
ANVISA GENERAL GUIDELINES:
- Registration needs to be required by a Brazilian company;
- This company must have the sanitary licenses required by Anvisa;
- Registration or notification is arrested for a minimum of 10 years or even without maturity;
- The registration or notification process takes from 3 to 18 months depending on the risk class applicable to your product.
MAPA registration is required so that the commercialization of veterinary products and agribusiness can occur. Thus, it is necessary that the following products are registered:
- Veterinary products;
- Products for agriculture;
- Supplements, food and additives;
- Products of animal or vegetable origin for human consumption.
The registration process is complex and takes 12 to 36 months to be completed. Mandala shares its experience to fast-forward such terms (commercial, legal and technical ones) by performing the process steps on your behalf.