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Brazil Medical Device Regulations

Agency
1. National Health Surveillance Agency (ANVISA) is responsible for regulating medical devices in Brazil. 2. National Institute of Metrology Standardization and Industrial Quality (INMETRO). 3. National Telecommunications Agency (ANATEL). 4. National Nuclear Energy Commission (CNEN). 5. National Research Ethics Commission (CONEP).
Medical Device Definition
Any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material, or another article, intended by the manufacturer to be used, alone or combined, in human beings, for any of the following specific medical purposes, and whose main action intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action by such means: a) diagnosis, prevention, monitoring, treatment (or alleviation) of a disease; b) diagnosis, monitoring, treatment, or repair of an injury or impairment; c) investigation, replacement, or alteration of the anatomy or of a physiological or pathological process or state; d) support or maintenance of life; e) control or support of conception; or f) provision of information through in vitro examination of samples from the human body, including organ and tissue donations.
Medical Device Classification System
International Classification Risk Level Examples
Class I Low risk Bandages, elastic bandages, and simple crutches.
Class II Medium risk Surgical instruments, dental drills, and diagnostic imaging equipment.
Class III High risk Pacemakers, artificial heart valves, and implantable defibrillators.
Class IV Maximum risk Radiation therapy equipment and extracorporeal circulation devices..
Note: All Medical Devices and In Vitro Diagnostics must be classified according to the 22 Risk Classification Rules.
Approval Process
Class III
  • Manufacturer or Importer must register at the sanitary vigilance and have an AFE (Operating permit license).
  • Brazil Good Manufacturing Practices Certificate is required for products under registration and is issued after ANVISA inspection.
  • Submit the Electronic Petitioning at Solicita system (https://solicita.anvisa.gov.br). Electronic Petitioning is the request made to ANVISA where all the documents should be uploaded electronically without the need to send the paper documents.
  • You will receive the receipt of the petition by ANVISA known as the electronic protocol.
  • ANVISA will review the registration application.
  • If approved, ANVISA will publish the registration number in the DOU (Diário Oficial da União) Official Journal of the Union.
Classification Approval procedure
Class I
  • Manufacturer or Importer must register at the sanitary vigilance and have an AFE (Operating permit license).
  • Submit the Electronic Petitioning at Solicita system (https://solicita.anvisa.gov.br). Electronic Petitioning is the request made to ANVISA where all the documents should be uploaded electronically without the need to send the paper documents.
  • You will receive the receipt of the petition by ANVISA known as an electronic protocol.
  • ANVISA will review the application for notification and issue a statement. The medical device notification processing will be carried out routinely within 30 (thirty) days following the protocol by the applicant.
  • If approved, ANVISA will publish the registration number in the DOU (Diário Oficial da União) Official Journal of the Union.
Class II
Class IV
Notes: The applicant must appoint a Brazil Registration Holder (BRH). The National Institute of Metrology, Standardization, and Industrial Quality (INMETRO) certification is required for certain types of devices where technical standards have been established. MD-IVDs Classes I and II are subjected to a notification. MD-IVDs Classes III and IV are subjected to registration.
Additional Information
Approval timeline MD and IVDs Class I & II: 30 days; MD and IVDs Class III & IV: 250 days. GMP Certification: 365 days. GMP by MDSAP: 180 days. The approval process can be delayed if additional information or testing is required.
License validity period Class I & II:- Does not expire. Class III & IV :- 5 years
Fees Notification/Registration
Device Small Company [BRL] Big Company [BRL]
Class I and II $351 $3,514
Class III and IV $2,127 $21,274
Authorization of Operation (AFE)
Type Small Company [BRL] Big Company [BRL]
Manufacturer $1,952 $19,524
Distributor $1,418 $14,183
Importer $1,418 $14,183
Good Manufacturing Practices (GMP)
Type Small Company [BRL] Big Company [BRL]
MERCOSUL $2,659 $26,593
Foreign $72,804 $72,804
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