Homologation and importation of medical products in Brazil - ANVISA
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Transcript of Homologation and importation of medical products in Brazil - ANVISA
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REGISTER OF HEALTH EQUIPMENT - ANVISA
Adler Araújo e Associados
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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.
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DEFINITION
Medical equipment are included in the category of health
equipment, as per their classification under RDC 185/2001.
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FLOWCHART – STEP 1HTTP://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)
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FLOWCHART – STEP 1HTTP://PORTAL.ANVISA.GOV.BR/
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.
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FLOWCHART – STEP 2 (WORK SHALL BE CARRIED OUT BY OUR FIRM)HTTP://PORTAL.ANVISA.GOV.BR/
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)?
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FLOWCHART – STEP 3 (DOCUMENTS)HTTP://PORTAL.ANVISA.GOV.BR/
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)
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FLOWCHART – STEP 4 (ADMINISTRATIVE PROCEEDINGS)HTTP://PORTAL.ANVISA.GOV.BR/
Electronic Petitioning
Delivery of Petition
ANVISA’s analysis of the proceedings
Publication on the Official Gazette of the Federal
Executive
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CLASSIFICATION
Equipment are classified into (4) categories, in accordance
with the risks they impose to health. Classification is set
forth by RDC 185/2001.
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CLASSIFICATION
• Class I – low risk
• Class II – intermediate risk
• Class III – high risk
• Class IV – maximum risk.
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CLASSIFICATION
In addition to the risk classification, there is the
classification by rule, which observes the indication and
purpose of the equipment.
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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.
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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.
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REGULARIZATION TYPES
There are (2) two types of equipment regularization before
Anvisa: register and enrollment.
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REGULARIZATION TYPES
The enrollment is a simpler regularization proceeding,
applicable to products of Classes I e II, described on RDC
24/09.
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REGULARIZATION TYPES
Medical equipment subject to register, provided that they
are not enrolled, are those of risk classes I, II, III e IV.
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REGULARIZATION TYPES
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/index.htm
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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.
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DOCUMENTS FOR ENROLLMENTCLASSES 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.
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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;
3. Original proof of payment of the sanitary authority’s fee;
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.
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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;
3. Original proof of payment of the sanitary authority’s fee;
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.
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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.
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ELECTRONIC PETITIONING
The company shall be previously registered before Anvisa,
in order to be able to take part of the electronic petitioning
proceedings.
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ELECTRONIC PETITIONING
Website for electronic petitioning:
https://www9.anvisa.gov.br/peticionamento/sat/global/
sistemas.asp
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ELECTRONIC PETITIONING
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.
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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.
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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.
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FILING
Copy of an identification document of the legal
representative and copy of the company’s By-laws shall be
attached to the petition.
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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.
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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.
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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.
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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.
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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.
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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.
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THANKS FOR READING.
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