Resolution RDC N° 3, February, 2, 2010

Sets the criteria for chronological analysis

of the processes of registration or Cadastre of products defined
as medical devices under the ANVISA.

The Board of Anvisa, using the powers conferred upon it by item IV of article. 11 of the Regulation
approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of subsection II,
paragraphs 1 and 3 of art. 54 of the Bylaws approved in accordance with Annex I of Decree No. 354 of
ANVISA of August 11, 2006, republished in the Official Gazette of August 21, 2006, at a meeting held on
November 9, 2009, adopts the following resolution I and the Chairman, determine its publication:

Article 1 The general criteria adopted for examining petitions for registration, post-registration,
registration or post-registration of Products for Health is chronological, based on the date and time of
petitioning.

Article 2 For purposes of the petitions in chronological order entry are grouped into four distinct groups:

I - registration application, referring to the first request for registration of a particular product or
product family.

II - request for cadastre on the first request for registration of a particular product or product family.

III - petition for post-registration, referring to the revalidation, amend, or archival record of the expiry of
a product or product family.

IV-petition for post-registration, referring to the revalidation, amend, or archival cadastre of the expiry
of a product or product family.

Article 3° For the chronological order of the petitions of the four groups listed in the previous article are
adopted separate lists for different types of products, according to the following groups:

I - I Subgroup - Products In Vitro Diagnostic Use:

a) in vitro diagnostic products intended for Immunohematology and blood-borne diseases:

b) other in vitro diagnostic products.

II - Subgroup II - Materials for use in Health

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 a) orthopedic protheses and orthoses;
b) other materials for use in health.

III - Subgroup - Equipment

a) electrical appliances with mandatory certification of compliance with technical standards;

b) equipment without mandatory certification.

Article 4 Above the chronology for the ordering of rows in each group or subgroup products grouped in
one or more of the following conditions:

I - Products identified as priorities by the Ministry of Health that are the subject of:

a) strategic actions relating to the health of the population:

b) projects or processes of technological development with funding from government agencies or
with partnerships that involves government agencies;

II - originated petitions demanding dismemberment of registers and cadastres of health products;

III - petitions concerning products that are complementary to others who are in the process of analysis;

IV - petitions concerning the same subject matter required by the same person and that can be
processed together;

Sole Paragraph. An indication of the priority products in accordance with paragraph I of this article, must
observe proper act of the Ministry of Health, detailing the motivation.

Article 5 of this Resolution enters into force 30 days after its publication.

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