Resolution RDC N° 97 of 9 November 2000

The Board of the National Agency of Sanitary Surveillance, in the exercise of the powers
conferred by the art. 11 item IV, of the Regulation of ANVS, in reunion Decree 3029 of April
16, 1999, at a meeting held on November 8, 2000,

considering the need to define the "product group" referred to in item 5 of Annex II of Law No.
9782 dated January 26, 1999, applied to products "health product" that deals the Law No. 6360
of September 23, 1976 and Decree No. 79.094, dated January 5, 1977;

considering there are no criteria to group health products according to their technology, or
application usage and health risks of its users, for purposes of registration, exemption and change
the record in ANVS;

adopted the following Resolution, and determine its publication:

Art. 1° it is defined as "product group" the ones which applies the item 5.3 of Annex II of Law
No. 9782, 1999, the "family of products for health" from the same manufacturer, where each
product that is contained has the following features:

a) product technology, including the fundamentals of its operation and its action, its content or
composition, performance, as well as accessories that integrate it;

b) indication, purpose or use for which the product is intended as indicated by the manufacturer;

c) precautions, restrictions, warnings, cautions and instructions for special storage and
transportation of the product.

Sole Paragraph. The devices discussed here are those defined as "products for health" to Law No.
6360 of September 23, 1976 and Decree 79.094, dated January 5, 1977.

Art. 2° the manufacturer or importer of health products may apply for registration, exemption
and change the family register these products, detailing the similarities and differences between
comparative characteristics of each type of product that is the family.

Art. 3° the ANVS evaluate the characteristics of health products described in Art.1° of this
Resolution and shall indicate their corresponding families.
5045-0910

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