Homologation and importation of medical products in Brazil - ANVISA

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REGISTER OF HEALTH EQUIPMENT - ANVISA

Adler Araújo e Associados


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 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)


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.


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)?


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)


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


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/index.htm

http://www.anvisa.gov.br/produtosaude/enquadramento/index.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 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.

http://www.anvisa.gov.br/servicos/form/protocolo/peticao_v11.doc




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.



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/

sistemas.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.


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Homologation and importation of medical products in Brazil - ANVISA