Registration of Medical Equipment's at ANVISA

RDC 185/2001

Sanitary Identification of equipment

Equipment Classification (Class + rule)

CLASS OF RISK I & II Does not Requires Internacional Inspection of ANVISA CLASS OF RISK III & IV Requires Internacional Inspection of ANVISA

* Time for grant of registration: 15 to 18 months;

Equipment Registration at ANVISA*

Report Economic Information

Certificate of Conformity (INMETRO)

Time to obtain: 3 months

Procedures for Registration

RATES
OPERATION Product Registration * Renewal of Registration * (every 5 years) VALUE $ 15,000.00 7,500.00

Inclusion or Charge in Record

International GMP Inspection ANVISA
(Equipment Class III / IV)

2,000.00
18,500.00

(Antecipate GMP Inspection)

Mandate safety

4,000.00 8,000.00 20,000.00**

Certificate of Conformity -INMETRO

*Including Lawyer, official translation and other expenses. ** Variation in accordance with the amount of testing and location of the manufacturer.

ProPep Nerve Monitoring System

Audit in loco; Laboratory Tests (ILAC standard); Technical Documentation; Stamp of according.

Equipment Registration at ANVISA

Class of Risk III; Require GMP Inspection for ANVISA; Permission to import after the ANVISA publish the record.