Homologation and importation of medical products in Brazil - ANVISA

REGISTER OF HEALTH
EQUIPMENT - ANVISA
Adler Araújo e Associados
WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR

DEFINITION
Health equipment are those used in the performance of
medical, dental, laboratory and physiotherapeutic proceedings; in beauty
and cosmetic treatment; diagnostic; treatment and patient’s monitoring.

DEFINITION
Medical equipment are included in the category of health
equipment, as per their classification under RDC 185/2001.

FLOWCHART – STEP 1
HTTP://PORTAL.ANVISA.GOV.BR/
Regularization of the
company before the
sanitation authorities
Company’s operating
license (AFE – as per
IN 01/94)
Municipal operating
license (LF – as per
local legislation)
Good Practices of
Manufacturing and
Crontrolling
(BPFC, as per RDC
59/01)

FLOWCHART – STEP 1
Each of the steps described in the previous slide depend on
physical adaption of the company’s installations to the laws
locally in force, specially phytosanitary and sanitary
regulations.

FLOWCHART – STEP 2 (WORK SHALL BE CARRIED OUT BY
OUR FIRM)
Sanitary
identification of
the equipment.
Classification of
the equipment (as
per RDC 185/01)
Is INMETRO
certification
necessary (as per
RDC 32/07)?
Is the economical
report necessary
(as per RDC
185/06)?

FLOWCHART – STEP 3 (DOCUMENTS)
Identification of the petition
Enrollment of
equipment (Cap II)
Register of
Equipment – Class
I or II
(Cap III)
Register of
Equipment Class
III or IV (Cap IV)
Modification of
Register or
Enrollment(Cap V)
Revalidation and
other Petition (Cap
VII)

FLOWCHART – STEP 4 (ADMINISTRATIVE PROCEEDINGS)
Electronic Petitioning
Delivery of Petition
ANVISA’s analysis of
the proceedings
Publication on the
Official Gazette of the
Federal Executive

CLASSIFICATION
Equipment are classified into (4) categories, in accordance
with the risks they impose to health. Classification is set forth by
RDC 185/2001.

CLASSIFICATION
• Class I – low risk
• Class II – intermediate risk
• Class III – high risk
• Class IV – maximum risk.

CLASSIFICATION
In addition to the risk classification, there is the classification by
rule, which observes the indication and purpose of the
equipment.

CLASSIFICATION
• Non-invasive Products: Rules 1, 2, 3 and 4;
• Invasive Products: Rules 5, 6, 7 and 8;
• Active Products: Rules 9, 10, 11, 12; and
• Special Rules: Rules 13, 14, 15, 16, 17 and 18.

CLASSIFICATION
The description of all classification rules are established under
Annex II of the Technical Ruling approved by Anvisa’s
Resolution RDC nº 185/01.

REGULARIZATION TYPES
There are (2) two types of equipment regularization before
Anvisa: register and enrollment.

The enrollment is a simpler regularization
proceeding, applicable to products of Classes I e II, described
on RDC 24/09.

Medical equipment subject to register, provided that they are
not enrolled, are those of risk classes I, II, III e IV.

Please note that some equipment of Classes I and II shall be
registered due to their nature and risk.
The list is available at:
http://www.anvisa.gov.br/produtosaude/enquadramento/ind
ex.htm

REQUIREMENTS
The following documents are necessary for register or
enrollment:
•Operating license issued by the Sanitary Authority;
•Operating authorization of the company (AFE) issued by
Anvisa;
•Certificate of compliance with the good manufacturing and
controling practices (CBPFC);
•The company shall be registered before Anvisa.

DOCUMENTS FOR ENROLLMENT
CLASSES I AND II
1. Front Page (http://www.anvisa.gov.br/servicos/form/protocolo/peticao_v11.doc);
2. Enrollment petition form;
3. Original proof of payment of the sanitary authority’s fee;
4. Comparative table of product for family enrollment;
5. Security and effectiveness for products with innovative indication/purpose
or new technology;
6. Proof relating to metrology matters for non-electric equipment with
measurement purposes.

SIMPLIFIED REGISTRY
CLASSES I AND II (IN 13/09 AND IN 02/11)
1. Front page (http://www.anvisa.gov.br/servicos/form/protocolo/peticao_v11.doc);
2. Technical sheet;
4. Label model and instructions of use;
5. Technical report;
6. Register or certificate of free trade of the product abroad;
7. Manufacturer authorization for the sale of the product in Brazil;
8. Specific technical regulation;
9. Annex II of IN 13/09 declaration;
10. CBPFC;
11. Comparative table of product for family enrollment. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR

REGISTER CLASSES IV, III AND CLASSES I AND II
FOR LAYPERSON’S USE (IN 02/11)
1. Front page (http://www.anvisa.gov.br/servicos/form/protocolo/peticao_v11.doc);
2. Form for medical equipment manufacturer or importer;
4. Label model and instructions of use;
5. Technical report;
6. Register or certificate of free trade of the product abroad;
7. Manufacturer authorization for the sale of the product in Brazil;
8. Specific technical regulation;
9. CBPFC;
10. Comparative table of product for family enrollment.

ELECTRONIC PETITIONING
The request for register or enrollment of a product before
Anvisa begins with the electronic petitioning. In order to go
through it, the requesting person or entity shall access Anvisa’s
website and fill in the requested information.

The company shall be previously registered before Anvisa, in
order to be able to take part of the electronic petitioning
proceedings.

Website for electronic petitioning:
https://www9.anvisa.gov.br/peticionamento/sat/global/siste
mas.asp

At the end of the electronic petitioning, a Federal Executive
Payment Form is created. It shall be duly paid and attached
to the proceedings along with proof of its payment.

FILING
Once the electronic petitioning proceedings are
concluded, a hard copy of the petition shall be filed before
Anvisa (Unidade de Atendimento e Protocolo), located in
Brasilia/DF.

FILING
The filing may be made either in person or by mail. The petition
shall be signed by the legal representatives and by the
company’s technician responsible.

FILING
Copy of an identification document of the legal
representative and copy of the company’s By-laws shall be
attached to the petition.

EXAMINATION BY ANVISA
After filing, Anvisa shall verify if the presented documents are
in accordance with the sanitary regulations in force. In
affirmative case, the registration or enrollment shall be sent for
publication on the Official Gazette of the Federal Executive. In
negative case, the proceedings shall be rejected or a
technical requirement to be complied with the requesting
person or entity may be set forth.

IMPORTING
Medical equipment importing is subject to consente by
ANVISA. The importer shall register the Importing License (LI) at
Siscomex. It shall be available for the purpose of examination
by the consenting agency.

IMPORTING
ANVISA shall publish the outcome of the examination within tem
working days, in case of Automatic Licensing; and within sixty
days, for Non-Automatic Licensing. In both cases, licenses shall
be valid for ninety days, for the purposes of shipping the produc
abroad.

IMPORTING
As a general rule, the shipping of the product abroad may occur
only after the end of the licensing process. Otherwise, the
importing shall be subject to the penalties set forth under
customs legislation.

IMPORTING
In the case of products subject to consent by Anvisa, the
licensing proceeding may be made effective after the shipping
of the product abroad, provided that licensing occurs before
the begining of the imports customs clearance.

IMPORTING
The customs clearance proceeding for imports is more
bureaucratic than the licensing proceeding of the product
before Anvisa. Please beware that such proceeding may take a
long time.

THANKS FOR READING.
FOR MORE INFORMATION:
www.brazilianlawblog.com
contato@adler.net.br

Homologation and importation of medical products in Brazil - ANVISA

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Homologation and importation of medical products in Brazil - ANVISA