I. ANVISA Introduction

ANVISA, the Brazilian Health Administration, is the administrative body of the Ministry of Health. ANVISA is mainly responsible for the pre- and post-market regulation of products such as cosmetics, pharmaceuticals, food, medical devices, tobacco, and hygiene products.

II. Applicable Regulation

(1) Medical equipments: Resolution RDC 185/2001 and RDC 40/2015

(2) Clinical trials: Resolution RDC 10/2015

(3) GMP for manufacturers of medical devices: Resolution RDC 183/2017

III. Medical Devices Classification

Brazil categorizes medical devices into Class I, Class II, Class III and Class IV.

IV. Medical Device Registration Material

For Class II, III or IV medical devices, the registration information is as follows:

(1) Application fee payment certificate;

(2) Information used to identify the manufacturer or importer and its medical devices;

(3) A copy of the authorization from the overseas manufacturer or exporter authorizing the importer to commercialize the medical device in Brazil;

(4) Registration certificate or free sale certificate issued by the competent authority of the country where the medical device is manufactured and marketed;

(5) Demonstrate compliance with the regulatory provisions in the technical regulations.

Class I medical device manufacturer or importer should submit documents (1), (2) and (5) above to ANVISA.

V. System Assessment

The GMP certificate is a certificate issued by ANVISA to certify that a company complies with good manufacturing practices. Medical devices exported to Brazil need to comply with BGMP requirements. Resolution RDC 183/2017 describes the regulatory process for granting GMP certification of medical devices to foreign manufacturers.

BGMP inspections are conducted for Class III and IV medical device manufacturers. BRH must conduct a risk analysis every 2 years to determine if a re-inspection is required or if the certificate can be renewed based on a document analysis.

Class I and Class II device market authorizations are valid in perpetuity, but may be revoked if there are issues of non-compliance or fraud at the time of reassessment. Premarket approval for Class III and IV products are valid for 10 years and renewal must begin one year prior to expiration.

VI. Brazilian Medical Device Registration Process

1. Determine product classification

2. Specify BRH

3. Certification or testing

4. Comply with BGMP requirements

5. Prepare registration documents

6. Submit application and registration documents

7. Registration approval

8. Sales

9. Duration of the certificate