Import Codes for Technological and Clinical Research Products

Posted onAuthorSerhat Demirkol

Importing products for clinical or technological research in Brazil requires adherence to specific codes outlined by the Brazilian Health Regulatory Agency (Anvisa). These codes facilitate the process of obtaining approval for importation, ensuring compliance with regulatory standards. Here’s a comprehensive overview of the import codes provided by Anvisa for various research purposes:

  1. Medications for Clinical Research (RDC 9/2015):
    • 90350: Anvisa Approval for Importation of Medications for Clinical Research, excluding specific procedures.
    • 90409: Anvisa Approval for Importation of Medication Samples for Clinical Research.
    • 90424: Anvisa Approval for Importation of Medication Samples for Clinical Research or Expanded Access Programs.
  2. Medical Devices for Medication Clinical Research (RDC 9/2015):
    • 90504: Anvisa Approval for Importation of Medical Devices for Monitoring Medication Clinical Research.
  3. Biological Material Collection Kits for Clinical Research:
    • 90504: Anvisa Approval for Importation of Medical Devices for Monitoring Medication Clinical Research (Due to the discontinuation of code 90352).
  4. Food, Cosmetics, Hygiene Products, and Sanitizers for Clinical Research:
    • 90496: Anvisa Approval for Importation of Food.
    • 90503: Anvisa Approval for Importation of Cosmetics, Hygiene Products, and Perfumes.
    • 90506: Anvisa Approval for Importation of Sanitizers.
  5. Devices Medical Research (RDC 837/2023):
    • 90351: Anvisa Approval for Importation of Medical Devices for Medical Device Clinical Research.
  6. Advanced Therapy Products (RDC 506/2021):
    • 90292: Anvisa Approval for Importation of Advanced Therapy Products for Clinical Research.
  7. Cosmetics, Sanitizers, or Food for Scientific or Technological Research (Outside RDCs 9/2015 and 837/2023):
    • 90459: Anvisa Approval for Importation of Food.
    • 90460: Anvisa Approval for Importation of Cosmetics, Perfumes, Hygiene Products, and Others.
    • 90498: Anvisa Approval for Importation of Sanitizers.

Each code corresponds to specific procedures outlined by Anvisa, ensuring the proper handling and evaluation of imported products. Adherence to Anvisa’s importation codes is crucial for researchers and entities involved in clinical and technological research in Brazil. These codes streamline the importation process while upholding regulatory standards to safeguard public health and promote scientific advancement.