ANVISA Registration

Class I Class II Class III Class IV
Appoint a corporation that holds a Company Working Allowance permit from ANVISA as your Brazilian Registration Holder (BRH).  It is not necessary for Foreign manufacturers to obtain this permit unless they plan on importing and distributing their own product in Brazil.
Next, you must submit a Brazilian Registration Holder letter of authorization to ANVISA.  The BRH will submit the registration application and technical file to ANVISA.  The BRH maintains control of the device registration and BGMP certificate.
Certain devices (mostly electrical medical devices) require INMETRO certification.  Testing for electrical medical products performed outside Brazil are usually accepted if performed by an ILAC-certified lab.  IEC 60601 series test reports must be less than two years old.  INMETRO certificates are valid for 5 years.
Class I and II devices that are listed in IN2/2011 or for any Class III or IV devices, the manufacturer must provide proof of compliance with BGMP as found in RDC 16/2013.  BGMP is similar to ISO 13485.  Fees must be paid every 2 years.
Next, the Technical File should be prepared.  This includes information about the device(s) in accordance with Annex III Part A/B/C in RDC 185/2001, as well as proposed labeling and instructions for use for the device(s).
Some devices will be required to be Economic Information Report (EIR) compliant according to RDC185/2006.  This report includes pricing comparisons for other markets, patient/user information and marketing materials.

Option 1: Obtaining the Certificate of Free Sale or device registration certificate proving home country approval from your Ministry of Health is.

OR

Option 2: Provide proof of registration in two other markets and provide reason(s) why your device(s) does not have home country approval.

Lastly, ANVISA will review the registration application.  Once approved, ANVISA will publish the registration number in the Diário Oficial da União (DOU).  Registration is valid for 5 years.  Cadastro (Class I and II) applications reviews typically take less time than Registro (Class III and IV) reviews.
Your Trusted Source For Compliance.
 

ANVISA Consulting

TechLink Blog